Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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. Non-GLP. Restrictions: Observation period only 72 h, only two observations, duration of treatment 24 h instead of 4h.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977

Materials and methods

Test guideline
Qualifier:
according to
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
other: albino rabbits (no more data)
Details on test animals 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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

Overall primary irritation score (PDII): 1.33 of 8 scores FDA (Draize), 1959,  

re-evaluated according to OECD 404

Reevaluation of the test results according to OECD404/GHS: only records for the shaved skin (not scarified) were considered  Erythema/ 24h     Erythema/72h  Oedema/24h  Oedema/72h
 animal 1  2  2  0  0
 animal 2  1  1  0  0
 animal 3  1  1  0  0
 animal 4  1  1  0  0
 animal 5  1  2  0  1
 animal 6  1  1  0  0
 average (single scores: animal 1-6)  1,1667  1,333  0  0,1667
 Primary irritation index I = Mean erythema score  (Erythema; 24h, 72h);  out of 4 scores  1,25  Primary irritation index II =  Mean oedema score (Oedema; 24h, 72h);   out of 4 scores  0,0833  
 Overall average PDII out of 8 scores; For evaluation according to GHS classification system:  1,3333    

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.

Applicant's summary and conclusion

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.