Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 292-081-6 | CAS number: 90530-40-8
Endpoint summary
Administrative data
Description of key information
Skin:
Based on the current data, 2-EHMA, iDMA, TDMA and LIMA, methacrylic acid ester 14.6 as well as NUMA as a UVCB and its single constituents are slightly irritating but clearly below the threshold for classification as skin irritant according to GHS.
Eye:
The UVCB substance NUMA with its single constituents are practically non to slightly irritating in the eye in analogy to 2-EHMA.
With only limited available data for the single constituents, this read across is conducted in a worst-case approach, adopting the test outcome and the classification for every constituent and the substance itself from the structural closely analogue 2-EHMA.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.
- Qualifier:
- according to guideline
- Guideline:
- other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
- Principles of method if other than guideline:
- Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials". - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean value 2,5 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and shaved/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
- Amount / concentration applied:
- undiluted 0.5 mL
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24h and 72h post application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100% the whole animal was covered with a gummed bandage
- Type of wrap if used: gummed bandage to wrap up the body of the test animal.
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by removal of the adhesive tape and the bandage, no wash off
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: No data in respect to reversibilty for times after exposure > 72h. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.92
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: No data in respect to reversibilty for times after exposure > 72h. Only data of shaved skin have been used, data of shaved and scarified skin have not been used.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- n-Decyl methacrylate was slightly irritating in a primary skin irritation study in rabbits (24-hour occlusive application, no wash of the
test substance). No data in respect to reversibilty for times after > 72h observation. Only data of shaved skin have been used, data of shaved and
scarified skin have not been used.
According to the results of this dermal irritation study n-Decylmethacrylate has to be classified as follows:
According to GefStoffV: slightly below the irritancy threshold (non-irritant, but 24 hour application, no wash off the test substance)
According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema)
According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour application, no wash off the test substance) slightly irritating - Executive summary:
- Remarks concerning the study result: The study for acute skin irritation/corrosion was performed before OECD 404 came into force. For this reason the test values were reevaluated according to OECD criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant. According to the results of this dermal irritation study n-Decylmethacrylate has to be classified as follows: According to GefStoffV: slightly below the irritancy threshold (non-irritant, but 24 hour application, no wash off the test substance) According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem and oedema) According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour application, no wash off the test substance) mildly irritating NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
In a primary dermal irritation study New Zealand White rabbits were dermally exposed (intact and scarified skin) to
0.5 mL undiluted n-Decyl methacrylate for 24 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize et al, 1959.
The mean erythema score (average value of the single scores (animals 1-6; erythema; intact skin, 24h and 72h) was determined to be 1.667 out of 4 and the mean edema score was 0.9167 out of 4.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets minimum scientific standards for a dermal irritation study and provides sufficient information for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Labeling Act Regulations, Section 191.12, Federal Register: 29, 13009 (1964)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24 and 72-h post dosing
- Number of animals:
- 6
- Details on study design:
- Six NZ White rabbits were restrained in stocks and the fur removed by clipping. Half of the exposed area was abraded and the other half remained intact. 0.5 ml(vol) of test compound was applied to the shaved intact and abraded skin sites and covered with surgical gauze. The area was then wrapped with impervious tape and a stockinette sleeve. Test material remained in contact for 24 hrs and then removed. Irritation scores were determined at 24 and 72 hours after patch removal.
- Irritation parameter:
- erythema score
- Remarks:
- erythema score
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Remarks:
- erythema score
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: scarified skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: scarified skin
- Irritant / corrosive response data:
- The reactions displayed at the first reading interval ranged from barely perceptible to moderate reddening and swelling of the skin, at both intact and abraded sites. Evidence of irritation persisted to the end of the test period in each animal. Examples of a general increase in turgor, discolouration and induration were also identified in this study.
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Executive summary:
The cutaneous irritation that could be induced by 2-ETHYLHEXYL METHACRYLATE was evaluated in the rabbit according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.11, published in the Federal Register (USA) -29 F.R. 13009, 1964.
2-ETHYLHEXYL METHACRYLATE was applied as supplied, at the dose level of 0.5 ml per animal, under an occlusive patch for 24 hours, to the intact and abraded skin of six New-Zealand albino rabbits. The cutaneous reactions were observed when the patches were removed and were again made at 72 hours.
Barely perceptible to moderate reddening and swelling of the skin were exhibited 24 hours following application. Reactions persisted to 72 hours. For the intact skin, the mean scores over 24 and 72 h were 1.9 and 2.2 for erythema and oedema, respectively.
Under these experimental conditions, 2-ETHYLHEXYL METHACRYLATE was considered as an slight irritant when applied 24 hours to the rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OSHA Toxicity Screening Test. Limited documentation of the study.
- Guideline:
- other: OSHA Toxicity Screening Test
- Principles of method if other than guideline:
- Draize Scoring
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean value 2,5 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Type of coverage:
- not specified
- Preparation of test site:
- other: shaved and shaved/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted, 3000 mg/kg body weight
- Duration of treatment / exposure:
- no substance removal reported
- Observation period:
- 24h and 72h post application and after 14 days
- Number of animals:
- 6
- Details on study design:
- SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4 - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #4
- Time point:
- other: mean 24 + 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Occlusive, exposure during whole observation (not washed) , observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- erythema score
- Basis:
- animal: #3, #5, #6
- Time point:
- other: mean 24 + 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Occlusive, exposure during whole observation (not washed) , observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #4
- Time point:
- other: mean 24 + 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Occlusive, exposure during whole observation (not washed) , observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- edema score
- Basis:
- animal: #3, #5, #6
- Time point:
- other: mean 24 + 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: Occlusive, exposure during whole observation (not washed) , observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU, GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In an acute dermal toxicity study 3000mg/kg of undiluted test substance were applicated to the shaved and shaved/abradet skin of 6 albino rabbits. Skin was observed after 24 und 72 hours for irritating reactions. Skin reactions were reevaluated acc. CLP criteria.
All scores were < 2.3. The highest mean erythema score is 2 for 3/6 animals, the highest edema score 0.5 for 3/6 animals. As the exposure time is too short, it strictly cannot be excluded that the substance has a higher irritating potential but reversibility is supposable. - Executive summary:
In an acute dermal toxicity study 3000 mg/kg of undiluted test substance were applicated to the shaved and shaved/abradet skin of 6 albino rabbits. Skin was observed after 24 und 72 hours for irritating reactions. Skin reactions were reevaluated acc. CLP criteria.
All scores were < 2.3. The highest mean erythema score is 2 for 3/6 animals, the highest edema score 0.5 for 3/6 animals. As the observation time is too short, it strictly cannot be excluded that the substance has a higher irritating potential but reversibility is supposable, but it is assumable that the animals were exposed with the test substance during the whole observation time.
According CLP classification Isodecylmethacrylate is not irritating in this study.
Remarks concerning the study result: The study for acute skin irritation/corrosion was performed before OECD 404 came into force. For this reason the test values were reevaluated according to CLP criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 20.06.1989-28.06.1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study OECD 404, GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 21 May 1981. EEC Directive 84/449/EEC, Part B: methods for the determination of Toxicity, B5. Acute Toxicity. Skin irritation. Official Journal of the European Communities, No L251, pp. 106-108
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The animals were housed individually. Conventional laboratory diet (mümmel z, ssniff / Soest) and an unrestricted supply of drinking water
were available. The temperature of the experimental animal room was 18 °C (±2 °C) and the relative humidity 40 to 50 %.
Lighting sequence: 12 hrs light, 12 hrs darkness
Condition time: 7 days - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g, undiluted
- Duration of treatment / exposure:
- 4 hours
At the end of the exposure period, residual test substance was removed by water - Observation period:
- After patch removal the skin was examined at 1 h, then at 24, 48 and 72 hrs and at day 8.
- Number of animals:
- 3, 10 weeks old
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data availible
- Type of wrap if used: non-irritating tape, semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by water
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24+48+72 hours
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 4-h semiocclusive exposure, reevaluated acc. CLP-criteria
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean 24+48+72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 4-h semiocclusive exposure, reevaluated acc. CLP-criteria
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24+48+72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 4-h semiocclusive exposure, reevaluated acc. CLP-criteria
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean 24+48+72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 4-h semiocclusive exposure, reevaluated acc. CLP-criteria
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24+48+72 hours
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 4-h semiocclusive exposure, reevaluated acc. CLP-criteria
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24+48+72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: 4-h semiocclusive exposure, reevaluated acc. CLP-criteria
- Other effects:
- No evidence of systemic effects.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: other: CLP, EU, GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- Isotridecyl methacrylate has some mild irritating potential to skin.
However, it is non-irritating with respect to EU and UN-GHS classification criteria. - Executive summary:
In a primary dermal irritation study (OECD 404, GLP) 3 New Zealand White rabbits were dermally exposed for 4 hours with 0.5 g undiluted Isotridecyl methacrylate under semiocclusiv conditions. Animals were observed after 1h, 24h, 48h 72h and after 8 or 9 days. The test was reevaluated acc. CLP criteria. Mean erythema scores after 24, 48 and 72 hours were 0, 0.33 and 0.66 of max. 4. Mean edema scores 0, 1.33 and 1.66 of max. 4. All reactions were fully reversible after 72 h or 8 days. Under CLP criteria Isotridecyl methacrylate is not irritating to skin.
The results demonstrate that Isotridecyl methacrylate (CAS 85736-97-6) is not a dermal irritant.
Therefore the test substance has to be classified - according to EU and GHS classification criteria - as non irritant for skin (GHS-hazard category: none).
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 15, 2017 - May 22, 2017 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted on 28 July 2015
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN™ - 0.38 cm2
- Tissue batch number(s): 17-EKIN-020
- Shipping date: 15 May 2017
- Delivery date: 16 May 2017
- Date of initiation of testing: 15 May 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature of post-treatment incubation: 37°C, 5% CO2 and saturated humidity
REMOVAL OF TEST MATERIAL AND CONTROLS
At the end of the exposure, each tissue was rinsed with approximately 25mL of sterile D-PBS,
filling and empting the tissue insert. The excess liquid was carefully removed and the sample
transferred in new wells pre-filled with 2mL/well of maintenance medium.
- Modifications to validated SOP: not indicated in the report
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 2mL/well of MTT ready-to-use solution
- Incubation time: approximately 3 hours at 37°C, 5% CO2 and saturated humidity
- Wavelength: 595 nm
- Linear OD range of spectrophotometer: confirmed by MTT formazan calibration curve
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
Criteria Classification
Mean relative viability ≤ 50% UN GHS Category 2 or 1
Mean relative viability > 50% UN GHS No Category (for member states that do not adopt optional category 3) - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL, NEGATIVE and POSITIVE CONTROL
- Amount(s) applied: 20 μL (i.e. approx. 53 µL/cm2) - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- A 42 ± 1 hour recovery period was allowed by incubation at 37°C, 5% CO2 and saturated humidity
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 95
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Viability range of three test item replicates: 84.7 - 103.3% ; standard deviation 9.4
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this GLP conform in vitro study according to OECD 439, the test item 2-EHMA is not irritant to the skin (UN GHS No Category).
- Executive summary:
The potential of the test item 2-EHMA to be irritant to the skin was investigated through an GLP conform in vitro skin irritation study according to OECD 439, using a commercial reconstructed human epidermis (RhE) model named EPISKIN™.
The blank, negative and positive controls gave acceptable results and the study was accepted as valid.
The mean cell viability of the test item treated tissues, after the blank subtraction, was 95%.
Based on the results obtained, the test item 2-EHMA is classified as not irritant to the skin (UN GHS No Category).
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study meets acceptable scientific standards and provides sufficient information for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959).
- Deviations:
- not specified
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2.5 kg
- Housing:
- Diet (e.g. ad libitum): Höing 222
- Water (e.g. ad libitum): tap water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-1
- Humidity (%): 50-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved or shaved/scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: two untreated areas (shaved and shaved/scarified) were used as the control
- Amount / concentration applied:
- undiluted; 0.5 ml
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24 and 72 hours post dosing
- Number of animals:
- 6
- Details on study design:
- Six New Zealand White rabbits were assigned to study. In order to investigate the reproducibility of the effects, each rabbit had two separate dose sites (shaved and shaved/scarified), which were treated with 0.5 ml of undiluted test material. In addition, two untreated areas (shaved and shaved/scarified) were used as the control. Only reactions which were different from those of the control were evaluated as positive reactions. For each treated dose site, 0.5 ml of undiluted test material was soaked onto a gauze patch (approx. 6 cm²/1 in²) which was held in place with adhesive tape on the shaved and shaved/scarified skin of the test animals. The animals were fixed in a holding device and their bodies were wrapped in a rubberised cloth for 24 hours. After this time dressing and adhesive tape were removed and the local reactions wer examined. 72 hours after application, the examinations were repeated. The test result is the average of the scores of the 24- and 72-hour examinations.
- Irritation parameter:
- edema score
- Remarks:
- edema score shaved skin
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- erythema score
- Remarks:
- erythema score
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: scarified skin
- Irritation parameter:
- erythema score
- Remarks:
- erythema score shaved skin
- Basis:
- mean
- Time point:
- other: 24+72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: shaved skin
- Irritation parameter:
- edema score
- Remarks:
- edema score scarified skin
- Basis:
- mean
- Time point:
- other: 24+72h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- other: scarified skin
- Irritant / corrosive response data:
- Shaved skin: 24 hours after application 5 of 6 animals showed well defined erythema. 72 hours after application 3 animals had well defined erythema while the other 3 had very slight erythema. Slight edema (and in two cases very slight edema) was present in all animals 24 hours after application. After 72 hours, no edema was observed except for one animal with very slight edema.
Shaved and scarified skin: 24 hours after application all animals showed well defined erythema. 72 hours after application the well defined erythema was still present in 5 of 6 animals while in one case it had developed to moderate to severe erythema. Slight edema (and in one case moderate edema) was present in all animals 24 hours after application. After 72 hours, very slight edema was observed in all animals. - Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Executive summary:
The cutaneous irritation that could be induced by 2-ETHYLHEXYL METHACRYLATE was evaluated in the rabbit according to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959). 2-ETHYLHEXYL METHACRYLATE was applied as supplied, at the dose level of 0.5 ml per animal, under an occlusive patch for 24 hours, to the intact and abraded skin of six New-Zealand albino rabbits. The cutaneous reactions were observed when the patches were removed and were again made at 72 hours. On the shaved skin, 24 hours after application 5 of 6 animals showed well defined erythema. 72 hours after application 3 animals had well defined erythema while the other 3 had very slight erythema. Slight edema (and in two cases very slight edema) was present in all animals 24 hours after application. After 72 hours, no edema was observed except for one animal with very slight edema. On the shaved and scarified skin, 24 hours after application all animals showed well defined erythema, 72 hours after application the well defined erythema was still present in 5 of 6 animals while in one case it had developed to moderate to severe erythema. Slight edema (and in one case moderate edema) was present in all animals 24 hours after application. After 72 hours, very slight edema was observed in all animals. For the shaved skin, the mean scores over 24 and 72 h were 1.66 and 0.9 for erythema and oedema, respectively. Under these experimental conditions, 2-ETHYLHEXYL METHACRYLATE was considered as an slight irritant when applied 24 hours to the rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.
- Qualifier:
- according to guideline
- Guideline:
- other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
- Principles of method if other than guideline:
- Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
Information about the method, described in the study report ( Draize test: skin irritation/corrosion), is given in the free text field "methods and
materials". - GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino rabbits (no more data)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: mean value 2,5 kg
- Housing: single housing
- Diet: rabbit standard diet (Höning 222), ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and shaved/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated skin areas of the test animals serve as the control (shaved, scarified).
- Amount / concentration applied:
- undiluted 0.5 mL
- Duration of treatment / exposure:
- 24 hour(s)
- Observation period:
- 24h and 72h post application
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: no data availible
- Type of wrap if used: gummed bandage to wrap up the body of the test animal.
REMOVAL OF TEST SUBSTANCE
- Removal of the test substance by removal of the adhesive tape and the bandage.
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Very severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4
Edema Formation
No edema: 0
Very slight edema (barely perceptible) : 1
Slight edem (edges of area well defined by definite raising):2
Moderate edema (raised approximately 1mm): 3
Severe edema (raised more than 1mm and extending beyond area of exposure):4
Maximum possible: 4 - Irritation parameter:
- erythema score
- Remarks:
- (mean)
- Basis:
- animal: # 1,# 2, #3, #4, #5, #6
- Time point:
- other: 24 and 72 hours
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean).
- Irritation parameter:
- edema score
- Remarks:
- (mean)
- Basis:
- animal: # 1,# 2, #3, #4, #5, #6
- Time point:
- other: 24 and 72 hours
- Score:
- 0.08
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. DSD (overall mean)
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24 + 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #3, #4, #6
- Time point:
- other: mean 24 + 72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- erythema score
- Basis:
- animal: #5
- Time point:
- other: mean 24 + 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #6
- Time point:
- other: mean 24 + 72 h
- Score:
- 0
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: mean 24 + 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: occlusive, exposure time 24 h, observation time 72 h, intact skin, reevaluated acc. CLP criteria
- Irritant / corrosive response data:
- Shaved skin: Under the described test conditions, 24 hours after application all of the animals showed signs of slight to moderate erythema. Slight erythema persisted in 4 animals after 72 hours and moderate erythema persited in 2 animals after 72 hours. Slight edema persited in 1 animal after 72 hours.
The treated abraded skin sites showed identical effects as the intact sites. For reevaluation only the sores of the intact skin were used.
Methacrylicacid ester 12.6 is a slight to moderate irritant under the conditions of the test.The data were reevaluated acc. DSD and CLP criteria and the test substance was classified as not irritating. - Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU, GHS, (Regulation (EC) No 1272/2008)
- Conclusions:
- Methacrylic acid ester 12.6 was slightly irritating in a primary skin irritation study (24 h exposure, occlusive, no wash of the test substance 72 h
observation time) in rabbits and is not skin irritating acc. CLP criteria.
Slightly irritating, but not irritating according to EU criteria.
Classification: not irritating - Executive summary:
In a primary dermal irritation study albino rabbits (strain: no data) were dermally exposed for 24 hours (intact and scarified skin) to 0.5 mL undiluted Methacrylic acid ester 12.6 for 24 hours. Animals then were observed for 72 hours. Irritation was scored by the method of Draize et al, 1959.
The test was performed with 6 animals so that both, the CLP and DSD approaches for evaluation were conducted. With the CLP approach the response of the individual animal values were averaged over the two observation times (24 hours and 72 hours after application) separate for erythema and edema. The mean erythema values were 1 for one animal, 1.5 for four animals and 2 for one animal. All values were below 2.3 that the substance has not to be classified acc. CLP criteria.
With the DSD approach the average score overall animals was used separate for erythema and edema. The overall mean erythema score was 1.25 and the mean overall edema score 0.08. Both values are below 2.3 that the substance has not to be classified acc. DSD criteria.
Methacrylic acid ester 12.6 is not skin irritating acc. CLP criteria.
Performance of the study does not comply with requirements of the relevant recent EU and OECD guidelines, where semi-occlusive dressing, an exposure period of 4 hours, treatment of only intact skin and a recovery period of up to 14 days is stipulated. This study is therefore of limited adequacy for C&L purposes due to intensity of the exposure regime and too short recovery period.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included as attachment. Please also see attached justification.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The constituents of the UVCB substance NUMA (Nonyl-Undecyl methacrylate) are structurally related mono alkyl methacrylate esters differing only in the respective alcoholic moieties. The main proportion of these esters are of the n-type the minor proportion of the iso type. Considering the small amount of iso-types and the negligible differences in (eco-) toxicological properties between the n- and iso types, in this assessment both types of one ester with one specific chain length are assessed together as a whole.
Further information is included as attachment. Please also see attached justification Chapter 1
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Further information is included as attachment. Please also see attached justification Chapter 1.
3. ANALOGUE APPROACH JUSTIFICATION
Please see attached justification Chapter 1 and 3.
4. DATA MATRIX
Please see attached justification Chapter 1.- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- other: read across
- Remarks:
- Based on read across to analogues substances and/or constituents of the target UVCB substance. The substance is regarded a mildly irritant to the skin, since the source chemicals are mildly irritating in rabbit in the worst case.
- Remarks on result:
- probability of mild irritation
- Remarks:
- Based on read across to analogues substances and/or constituents of the target UVCB substance. The substance is regarded a mildly irritant to the skin, since the source chemicals are mildly irritating in rabbit in the worst case.
- Conclusions:
- Based on read across to analogues substances and/or constituents of the target UVCB substance. The UVCB substance is regarded a mildly irritant to the skin, since the source chemicals are mildly irritating in rabbit in the worst case.
- Executive summary:
Based on the current data, 2-EHMA, iDMA, TDMA and LIMA, methacrylic acid ester 14.6 as well as NUMA as a UVCB and its single constituents are slightly irritating but clearly below the threshold for classification as skin irritant according to GHS.
Referenceopen allclose all
Overall primary irritation score (PDII): 2.6 of 8 scores FDA (Draize), 1959,
re-evaluated according to OECD 404
|
||||||||||||||||||||||||||||||||||||||||||||||||||
Remarks concerning the study result: The study for acute skin irritation/
corrosion was performed before OECD 404 came into force. For this reason the
test values were reevaluated according to OECD criteria and test scores
(erythema, oedema) obtained for the scarified skin were regarded as irrelevant.
Classification criteria according to the different classification systems:
EU-GHS:
Category 1: Corrosive subcategories
Corrosive in >= 1 of 3 animals
(applies to authorities not using subcategories): Corrosive
(only applies to some authorities)
Subcategory Exposure Observation
------------------------------------------------------------
1A <= 3 minutes <= 1 hour
1B > 3 minutes to <= 1 hour <= 14 days
1C > 1 hour to <= 4 hours <= 14 days
------------------------------------------------------------
A: Single harmonized corrosion category, using the results of animal testing.
A: Corrosive is a test substance that produces destruction of skin tissue, namely,
visible necrosis through the epidermis and into the dermis, in at least 1 of 3
tested animals after exposure up to 4 hours duration. Corrosive reactions are
typified by ulcers, bleeding, bloody scrabs and, by the end of observation at 14
days, by discoloration due to bleaching of the skin, complete areas of alopecia
and scars. Histopathologic determinations should be consided evaluate questionable
lesions.
Substances and/or mixtures are considered corrosive (Skin categorry 1) if it has
a pH of 2 or less or a pH of 11.5 or greater. If consideration of alkali/acid
reserve suggests the substance or prepatration may not be corrosive despite the
low or high pH value, then further testing needs to be carried out to confirm
this, preferably by use of an appropriate validated in vitro test.
Category 2:
(1) Mean value of >= 2.3 to < 4.0 for erythem/eschar or for oedema in at least 2
of 3 animals from gradings at 24, 48 and 72 hours after patch removal or, if
reactions are delayed, from grades on 3 consecutive days after the onset of
skin reactions, or
(2) Inflammation that persits to the end of the observation period normally 14
days in at least 2 animals, particularly taking into account alopecia
(limited area), hyperkeratosis, hyperplasia, and scalling, or
(3) In some cases where there is pronounced variability of response amoung
animals, with very definite positive effects related to chemical exposure
in a single animal but less than the criteria above.
UN-GHS (additional category 3):
Category 3: Mild irritant (Applies to only some authorities for e.g. UN-GHS)
Mean value of >= 1.5 to < 2.3 for erythem/eschar or for oedema from gradings
in at least 2 of 3 tested animals from grades at 24, 48 and 72 hours or, if
reactions are delayed, from grades on 3 consecutive days after the onset of
skin reactions (when not included in the irritant category above).
According to the results of this dermal irritation study n-Decylmethacrylate
has to be classified as follows:
According to GefStoffV: slightly below the irritancy threshold (non-irritant,
but 24 hour exposition, no wash off the test substance)
According to EU-GHS (CLP): Hazard category: None (effects < 2.3 both erythem
and oedema)
According to UN-GHS: Hazard category: 3 (Erythem > 1.5 but < 2.3, 24 hour
exposition, no wash off the test substance)
ems:
Classification criteria according to the different classification systems:
Classification criteria according to the different classification systems:
Classification criteria according to the different classification systems:
EU-GHS:
Category 1: Corrosive subcategories
Corrosive in >= 1 of 3 animals
(applies to authorities not using subcategories): Corrosive
(only applies to some authorities)
Subcat. Exposure Observation
1A <= 3 minutes <= 1 hour
1B > 3 minutes -- <= 1 hour <= 14 days
1C > 1 hour -- <= 4 hours <= 14 days
A single harmonized corrosion category is provided in Table 3.2.1, using the results of animal
testing. A corrosive is a test material that produces destruction of skin tissue, namely, visible necrosis
through the epidermis and into the dermis, in at least 1 of 3 tested animals after exposure up to a 4 hour
duration. Corrosive reactions are typified by ulcers, bleeding, bloody scabs and, by the end of observation at
14 days, by discoloration due to blanching of the skin, complete areas of alopecia and scars. Histopathology
should be considered to discern questionable lesions.
A mixture is considered corrosive (Skin Category 1) if it has a pH of 2 or less or a pH of 11.5 or greater. If
consideration of alkali/acid reserve suggests the substance or preparation may not be corrosive despite the low or high pH value, then further testing needs to be carried out to confirm this, preferably by use of an appropriate validated in vitro test.
Isodecyl methacrylate, Skin irritation
Reevaluation acc. to CLP regulation, Skin irritation
Rohm & Haas 1973
Albino Rabbits
Coverage: not stated, shaved skin (results from scarified skin were regarded irrelevant)
Dosage: 3000 mg/kg, undiluted. No substance removal reported
Skin reactions
Animal Nr. |
Erythema 24 h |
Erythema 48 h |
Erythema 72h |
Mean Erythema |
Edema 24 h |
Edema 48 h |
Edema 72 h |
Mean Edema |
1 |
0 |
- |
0 |
0 |
0 |
- |
0 |
0 |
2 |
0 |
- |
0 |
0 |
0 |
- |
0 |
0 |
3 |
2 |
- |
2 |
2 |
1 |
- |
0 |
0.5 |
4 |
0 |
- |
0 |
0 |
0 |
- |
0 |
0 |
5 |
2 |
- |
2 |
2 |
1 |
- |
0 |
0.5 |
6 |
2 |
- |
2 |
2 |
1 |
- |
0 |
0.5 |
Comparison with CLP criteria:
Remark: Exposure time was longer than 4 hours (during the whole
observation time) and the observation time was only 72 hours.
All scores < 2.3. The highest mean erythema score is 2 for 3/6 animals,
the highest edema score 0.5 for 3/6 animals..
Reversibility: no pathologic changes were noted 14 days after exposure. Remarks concerning the study result: The study for acute skin irritation/ corrosion was performed before OECD 404 came into force. For this reason the test values were reevaluated according to OECD criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.
Tabulated results
| Blank | Negative Control | |||||
| OD | sample | OD | OD-blank | mean | Viability (%) | |
| 0.037 | N1-1 | 0.696 | 0.6590 | |||
| 0.037 | N1-2 | 0.627 | 0.5900 | 0.6245 | 98.7 | |
| 0.036 | N2-1 | 0.702 | 0.6650 | |||
| 0.037 | N2-2 | 0.673 | 0.6360 | 0.6505 | 102.8 | |
| 0.038 | N3-1 | 0.675 | 0.6380 | |||
| 0.037 | N3-2 | 0.647 | 0.6100 | 0.6240 | 98.6 | |
| mean | 0.037 | 0.7 | 0.6 | 100 | ||
| SD | 0.001 | 0.03 | 0.02 | 2.4 | ||
| CV (%) | 1.7 | 4.3 | 2.4 | 2.4 | ||
| Positive Control | ||||||
| sample | OD | OD-blank | mean | Viability (%) | ||
| P1-1 | 0.081 | 0.0440 | ||||
| P1-2 | 0.075 | 0.0380 | 0.0410 | 6.5 | ||
| P2-1 | 0.068 | 0.0310 | ||||
| P2-2 | 0.065 | 0.0280 | 0.0295 | 4.7 | ||
| P3-1 | 0.086 | 0.0490 | ||||
| P3-2 | 0.081 | 0.0440 | 0.0465 | 7.3 | ||
| mean | 0.1 | 0.04 | 6 | |||
| SD | 0.01 | 0.01 | 2.4 | |||
| CV (%) | 10.8 | 22.2 | 22.2 | |||
| Test item | ||||||
| sample | OD | OD-blank | mean | Viability (%) | ||
| A1-1 | 0.653 | 0.6160 | ||||
| A1-2 | 0.632 | 0.5950 | 0.6055 | 95.7 | ||
| A2-1 | 0.592 | 0.5550 | ||||
| A2-2 | 0.554 | 0.5170 | 0.5360 | 84.7 | ||
| A3-1 | 0.710 | 0.6730 | ||||
| A3-2 | 0.672 | 0.6350 | 0.6540 | 103.3 | ||
| mean | 0.6 | 0.6 | 95 | |||
| SD | 0.06 | 0.06 | 9.4 | |||
| CV (%) | 8.8 | 9.9 | 9.9 |
Overall primary irritation score (PDII): 1.33 of 8 scores FDA (Draize), 1959,
re-evaluated according to OECD 404
|
||||||||||||||||||||||||||||||||||||||||||||||||||
Remarks concerning the study result: The study for acute skin irritation/ corrosion was performed before OECD 404 came into force. For this reason the test values were reevaluated according to OECD criteria and test scores (erythema, oedema) obtained for the scarified skin were regarded as irrelevant.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2,4 - 2,6 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each treated animal
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hours, unrinsed
- Observation period (in vivo):
- 7 days after treatment
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: mean 24 + 48 +72 hr
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: mean 24 + 48 +72 hr
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: mean 24 + 48+ 72 hr
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: mean 24 + 48+ 72 hr
- Score:
- 0
- Max. score:
- 3
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: other: CLP, EU, GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- Classification: not irritating
- Executive summary:
In a primary eye irritation study ( according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FAD Draize (1959)) 0.1 mL undiluted Methacrylic acid ester 12.6 was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits, (2.4 -2.6 kg body weight) for 72 hours (not rinsed). Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according CLP criteria.
In this study Methacrylic acid ester 12.6 is not irritating to eyes.
OECD GHS Category: none
EU GHS Category: none
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 February 1987
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each treated animal serves as controll
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml
The eyes were not rinsed after administration of the test substance. - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Three rabbits had 0.1 ml of undiluted test material instilled into the conjunctival sac of the left eye. The right eye of each rabbit, which remained untreated, served as a control. Animals were observed for irritating effects of the cornea, iris, conjunctivae 1, 24, 48 and 72 hours after treatment.
SCORING SYSTEM: Draize scale - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Except for some initial redness, none of the animals showed any effects of the treatment.
- Interpretation of results:
- not irritating
- Conclusions:
- Classification: not irritating
- Executive summary:
The ocular irritation that could be induced by 3,5,5 -Trimethylhexyl methacrylate was evaluated in the rabbit according to the recommendations of the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959). A single application of 0.1 ml of 3,5,5 -Trimethylhexyl methacrylate in its original form was placed into the conjuctival sac of one eye of three rabbits.
The ocular reactions were observed at 1, 24, 48 and 72 hours after the instillation. Mean values (24+48+72 h) for ocular irritation were: 0.0 for chemosis, redness, chemosis and opacity. Under these experimental conditions,
3,5,5 -Trimethylhexyl methacrylate was considered as not irritating when administered to the rabbit by ocular route.
OECD GHS Category: none
EU GHS Category: none
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. Study well documented, meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
- Principles of method if other than guideline:
- Method: according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2,4 - 2,6 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of each treated animal
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hours, unrinsed
- Observation period (in vivo):
- 7 days after treatment
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- other: index of primary eye irritation
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 13
- Reversibility:
- fully reversible
- Remarks on result:
- other: re-evaluated according to OECD405
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: not irritating
- Executive summary:
In a primary eye irritation study ( according to Appraisal of the Safety of Chemicals in foods, drugs and cosmetics, FDA Draize (1959)) 0.1 mL undiluted Decyl methacrylate, roh was instilled into the conjunctival sac of the left eye of 6 New Zealand White rabbits, (2.4 -2.6 kg body weight) for 72 hours (not rinsed). Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.
In this study Decyl methacrylate, roh is not irritating to eyes.
OECD GHS Category: none
EU GHS Category: none
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Labeling Act Regulations, Section 191.12, Federal Register: 29, 13009 (1964)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Not rinsed
- Observation period (in vivo):
- 24, 48 and 72 hours post dosing
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: opthalmoscope and 2.0% fluoroscein sodium solution - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Conclusions:
- Very sligthly irritating
- Executive summary:
The ocular irritation that could be induced by 2-ETHYLHEXYL METHACRYLATEwas evaluated in the rabbit according to the recommendations of the Federal Hazardous Substances Labelling Act Regulations, Section 191.12, published in the Federal Register (USA) -29 F.R. 13009, 1964.A single application of 0.1 mlof 2-ETHYLHEXYL METHACRYLATE in its original form was placed into the conjunctival sac of one eye of six New-Zealand white rabbits. The ocular reactions were observed at 24, 48 and 72 hours after the instillation. Mean values (24+48+72 h) for ocular irritation were 0.11 for chemosis, 0.33 for enanthema and 0.00 for congestion and opacity. Under these experimental conditions, 2-ETHYLHEXYL METHACRYLATE was considered as very slightly irritating when administered to the rabbit by ocular route.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OSHA Toxicity Screening Test. Limited documentation of the study.
- Qualifier:
- according to guideline
- Guideline:
- other: OSHA Toxicity Screening Test
- Principles of method if other than guideline:
- Draize
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Albino
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hours, unrinsed
- Observation period (in vivo):
- 7 days after treatment
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: not rinsed
- Irritation parameter:
- other: index of primary eye irritation
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hr
- Score:
- 0
- Max. score:
- 13
- Reversibility:
- fully reversible
- Remarks on result:
- other: re-evaluated according to OECD405
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Classification: not irritating
- Executive summary:
In a primary eye irritation study (OSHA Toxicity Screening Test, according to Draize) 0.1 mL undiluted Isodecyl methacrylate was was applied to 6 Albino rabbits. Animals were observed for 7 days. Irritation was scored according to Draize scoring and re-evalutated according OECD-GHS criteria.
In this study Isodecyl methacrylate is not irritating to eyes.
EU GHS Category: none
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 20-06-1989 - 28-06-1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study OECD 401, GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Lippische Versuchstieranstalt Hagemann GmbH & Co. KG, Extertal, Germany
Age at study initiation: 10 w
The animals were housed individually. Conventional laboratory diet (mümmel z, ssniff / Soest) and an unrestricted supply of drinking water
were available. The temperature of the experimental animal room was 18 °C (±2 °C) and the relative humidity 40 to 50 %.
Lighting sequence: 12 hrs light, 12 hrs darkness
Condition time: 7 days - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- The eyes were not washed out following the instillation
- Observation period (in vivo):
- 1, 24, 48 and 72 hours as well as 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: ophthalmoscope and fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: mean 24 + 48 + 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: mean 24 + 48 + 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: mean 24 + 48 + 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- other: mean 24 + 48 + 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One hour after dosing, one animal exhibited slight conjunctival redness and slight discharge, a second animal slight discharge only.
At 24 hrs following dosing, all signs of irritation had resolved.
The remaining animal showed no signs of irritation at any time during the test. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: other: CLP, EU, GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In an OECD 405 eye irritation study Isotridecyl methacrylate showed no signs of irritation. Therefore the substance has not to be classified acc. CLP
criteria. - Executive summary:
In an OECD 405 guideline study, with GLP, Isotridecyl methacrylate (0.1 ml) was placed in the conjunctival sac of the right eye of three New Zealand White rabbits. The lids were then gently held together for one second. The test eyes were not washed out following the instillation. The left eye remained untreated for control. The eyes were examined at 1, 24, 48 and 72 hours as well as 8 days from beginning of test. Eye irritation was scored for signs of corneal damage (density, area), iris reaction and lesions of the conjunctivae (erythema, chemosis, discharge). Additionally, the cornea was examined with the aid of fluorescein after recording the observations at 24 hours. One hour after dosing, one animals exhibited slight conjunctival redness and slight discharge. A second animal exhibited slight discharge one hour after dosing. At 24 hours following dosing all signs of irritation had resolved. The remaining third animal showed no signs of irritation at any time during the test. Isotridecyl methacrylate is considered as non-irritating to eyes.
The results demonstrate that Isotridecyl methacrylate (CAS 85736-97-6) is not an eye irritant.
Therefore the test substance has not to be classified - according CLP criteria.
NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study. The test followed recognized toxicology testing procedures and recognized scoring procedures of the results.
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation:
- Weight at study initiation: 2.4-2.6 kg
- Housing: no data
- Diet (e.g. ad libitum): Mümmel Z, Plange
- Water (e.g. ad libitum): tap water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- Not rinsed
- Observation period (in vivo):
- 24, 48 and 72 h, and 4, 5, 6 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Six New Zealand White rabbits had 0.1 ml of undiluted test material instilled into the conjunctival sac of the left eye. The right eye of each rabbit, which remained untreated, served as a control. Animals were observed for irritating effects of the cornea, iris, conjunctivae 24, 48 and 72 hours and 4, 5, 6 and 7 days after treatment.
SCORING SYSTEM: Draize scale - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Except for some initial redness, none of the animals showed any effects of the treatment.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
- Executive summary:
The ocular irritation that could be induced by 2-ethylhexyl methacrylate was evaluated in the rabbit according to the recommendations of the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", Division of Pharmacology, FDA (Draize) (1959). A single application of 0.1 ml of 2-ethylhexyl methacrylate in its original form was placed into the conjunctival sac of one eye of six New-Zealand white rabbits. The ocular reactions were observed at 24, 48 and 72 hours and up to 7 days after the instillation. Mean values (24+48+72 h) for ocular irritation were: 0.0 for chemosis, enanthema, congestion and opacity. Under these experimental conditions, 2-ethylhexyl methacrylate was considered as not irritating when administered to the rabbit by ocular route.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included as attachment. Please also see attached justification.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The constituents of the UVCB substance NUMA (Nonyl-Undecyl methacrylate) are structurally related mono alkyl methacrylate esters differing only in the respective alcoholic moieties. The main proportion of these esters are of the n-type the minor proportion of the iso type. Considering the small amount of iso-types and the negligible differences in (eco-) toxicological properties between the n- and iso types, in this assessment both types of one ester with one specific chain length are assessed together as a whole.
Further information is included as attachment. Please also see attached justification Chapter 1
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Further information is included as attachment. Please also see attached justification Chapter 1.
3. ANALOGUE APPROACH JUSTIFICATION
Please see attached justification Chapter 1 and 3.
4. DATA MATRIX
Please see attached justification Chapter 1.- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- other:
- Remarks:
- Based on read across to analogues substances and/or constituents of the target UVCB substance. The substance is practically non to slightly irritating in the eye in analogy to 2-EHMA.
- Remarks on result:
- probability of weak irritation
- Remarks:
- Based on read across to analogues substances and/or constituents of the target UVCB substance. The substance is practically non to slightly irritating in the eye in analogy to 2-EHMA.
- Conclusions:
- The UVCB substance NUMA with its single constituents are practically non to slightly irritating in the eye in analogy to 2-EHMA.
- Executive summary:
The UVCB substance NUMA with its single constituents are practically non to slightly irritating in the eye in analogy to 2-EHMA.
With only limited available data for the single constituents, this read across is conducted in a worst-case approach, adopting the test outcome and the classification for every constituent and the substance itself from the structural closely analogue 2-EHMA. This read across is conducted with high confidence.
Referenceopen allclose all
Index of primary eye irritation: 0.0 of 13 (re-evaluated according to
OECD 405)
An initial slight irritation of the conjunctiva within the first 8 hours
(irritation scores 0-1) disappeared entirely within the first 24 h; non-irritating
Classification of eye irritation studies according OECD-GHS-criteria
Substance: Methacrylic acid ester 12,6 CAS: 90551 -76 -1
Internal No.: UNTER77 -005
Date/Expert: 25 -03 -2010/RG
Animal No. |
Corneal opacity/Hornhauttrübung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Iritis/Regenbogenhautentzündung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
none |
|||||||
Classification: Hazard Category |
none |
Classification Criteria for serious Eye Damage/Eye
Category 1
- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
- Mean Draize score in 2 of 3 canimals:
corneal opacity≥3
iritis≥ 1,5
Category 2
- Reversible adverse effects on cornea, iris, conjunctiva
- Mean Draize score in 2 of 3 animals:
corneal opacity >= 1
iritis >=1
redness >= 2
chemosis >= 2
Subcategory 2A
- Reversible in 21 days
Subcategory 2B
- Reversible in 7 days
MMAS (Modified Maximum Average Score) (0+0+0)/3 = 0
Classification of eye irritation studies according OECD-GHS-criteria
Substance: 3,5,5 -Trimethylhexyl methacrylate CAS: 13453 -03 -7
Internal No.: LITSU 01-0120
Date/Expert: 14-05 -2018/RG
Animal No. |
Corneal opacity/Hornhauttrübung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1 |
0 |
0 |
0 |
0 |
- |
- |
||
2 |
0 |
0 |
0 |
0 |
- |
- |
||
3 |
0 |
0 |
0 |
0 |
- |
- |
||
none |
||||||||
Animal No. |
Iritis/Regenbogenhautentzündung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1 |
0 |
0 |
0 |
0 |
- |
- |
||
2 |
0 |
0 |
0 |
0 |
- |
- |
||
3 |
0 |
0 |
0 |
0 |
- |
- |
||
none |
||||||||
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1 |
0 |
0 |
0 |
0 |
- |
- |
||
2 |
0 |
0 |
0 |
0 |
- |
- |
||
3 |
0 |
0 |
0 |
0 |
- |
- |
||
none |
||||||||
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|||
1 |
0 |
0 |
0 |
0 |
- |
- |
|
2 |
0 |
0 |
0 |
0 |
- |
- |
|
3 |
0 |
0 |
0 |
0 |
- |
- |
|
none |
|||||||
Classification: Hazard Category |
none |
Classification Criteria for serious Eye Damage
Category 1
- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
- Mean Draize score in 2 of 3 animals:
corneal opacity≥3
iritis≥ 1,5
Category 2
- Reversible adverse effects on cornea, iris, conjunctiva
- Mean Draize score in 2 of 3 animals:
corneal opacity >= 1
iritis>= 1
redness >= 2
chemosis >= 2
Subcategory 2A
- Reversible in 21 days
Subcategory 2B
- Reversible in 7 days
Index of primary eye irritation: 0.0 of 13 (re-evaluated according to
OECD 405)
An initial slight irritation of the conjunctiva within the first 8 hours
(irritation scores 0 -2) disappeared entirely within the first 24 h; non-irritating
Classification of eye irritation studies according OECD-GHS-criteria
Substance: Decyl methacrylate, roh CAS: 3179 -47 -3
Internal No.: UNTER78 -016
Date/Expert: 10 -05 -2012/RG
Animal No. |
Corneal opacity/Hornhauttrübung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Iritis/Regenbogenhautentzündung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
none |
|||||||
Classification: Hazard Category |
none |
Classification Criteria for serious Eye Damage/Eye
Category 1
- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
- Mean Draize score in 2 of 3 canimals:
corneal opacity ≥3
iritis ≥ 1,5
Category 2
- Reversible adverse effects on cornea, iris, conjunctiva
- Mean Draize score in 2 of 3 animals:
corneal opacity >= 1
iritis >= 1
redness >= 2
chemosis >= 2
Subcategory 2A
- Reversible in 21 days
Subcategory 2B
- Reversible in 7 days
Index of primary eye irritation: 0.0 of 13 (re-evaluated according to
OECD 405)
An initial irritation of the conjunctiva within the first hour
(irritation score 2.3) disappeared entirely within the first 24 h; non-irritating
Classification of eye irritation studies according OECD-GHS-criteria
Substance: Isodecyl methacrylate CAS: 29964 -84 -9
Internal No.: UNTER 00 -113
Date/Expert: 06 -12 -12 / Mls
Animal No. |
Corneal opacity/Hornhauttrübung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Iritis/Regenbogenhautentzündung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Conjunctiva redness (erythem) /Bindehautrötung[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
||||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
||||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
||
none |
||||||||
Animal No. |
Conjunctiva chemosis /Bindehautödem[Scores] |
Mean Draize score |
Reversibility [scores] |
Hazard category |
|||
after 24 h |
after 48 h |
after 72 h |
in 7 days |
in 21 days |
|||
1, 2 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
3, 4 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
5, 6 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
- |
|
none |
|||||||
Classification: Hazard Category |
none |
Classification Criteria for serious Eye Damage/Eye
Category 1
- Irreversible damage to cornea, iris, conjunctiva 21 days after exposure in at least one animal
- Mean Draize score in 2 of 3 canimals:
corneal opacity≥3
iritis≥ 1,5
Category 2
- Reversible adverse effects on cornea, iris, conjunctiva
- Mean Draize score in 2 of 3 animals:
corneal opacity >= 1
iritis >=1
redness >= 2
chemosis >= 2
Subcategory 2A
- Reversible in 21 days
Subcategory 2B
- Reversible in 7 days
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
