Registration Dossier
Registration Dossier
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EC number: 290-754-9 | CAS number: 90218-76-1
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- Ecotoxicological Summary
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- Short-term toxicity to fish
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- Irritation / corrosion
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Endpoint summary
Administrative data
Description of key information
1,2,4 -benzenetricarboxylic acid, mixed decyl and octyl triesters showed either no or slight irritant to skin and eye
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:
- supporting study
- Study period:
- 29 May 2013 to 01 June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with OECD and EU Guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.49 to 2.59 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: Free access to food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon., UK)
- Water: Free access to mains drinking water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23 degrees C.
- Humidity (%): The humidity was set to achieve 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to 12 hours continous light (06:00 to 18:00) and 12 hours darkness.
IN-LIFE DATES: From: 29 March 2013 To: 1 April 2013 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
The pH of the test item was determined prior to the commencement of the study and found to be as follows:
Undiluted as supplied: Immediately: pH 7.9
90% v/v aqueous preparation of the test item: immediately: pH 7.7, after 10 minutes: pH 7.8 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: No information.
- % coverage: No information.
- Type of wrap if used: 2.5 cm x 2.5 cm cotton gauze patch. Secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing: The corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale:
Erythema and Eschar Formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema: 4
Edema Formation:
No edema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well-defined by definite raising) : 2
Moderate edema (raised approximately 1 millimeter): 3
Severe edema (raised more than 1 millimeter and extending beyond the area of exposure): 4
Any other skin reactions and clinical signs of toxicity, if present, were also recorded.
Individual body weights were recorded on Day O (the day of dosing) and at the end of the observation period. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: Total of erythema and edema scores at 24 and 72 hours for all 3 animals divided by 6
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Very slight erythema was noted at one treated skin site one hour after patch removal. No evidence of skin irritation was noted at two treated skin sites.
- Other effects:
- All animals showed expected gain in body weight.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize Classification Scheme.No corrosive effects were noted.
- Executive summary:
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.
A single 4 -hour semi-occluded application of the test item to intact skin of three rabbits produced an isolated incident of very slight erythema at one treated skin site one hour after patch removal. No evidence of skin irritation was noted at two treated skin sites.
The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-04-18 to 1989-05-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 8 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 10 x 10 cm of shaved skin of the dorsal and lateral parts of the trunk of the animals, application of the test substance on a skin area of approx. 6 cm²
- % coverage: not mentioned
- Type of wrap if used: semi-occlusion with a gauze patch (2.5 cm x 2.5 cm). The patch was secured in position by an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline 404 - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 8
- Reversibility:
- fully reversible within: 6 to 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: after 6 days Scaling which disappears after 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1.56
- Edema: 0.11
All animals showed slight to well-defined erythema, and two animals after 1 resp. 24 hours slight edema. Allanimals were free of symptoms after 6 - 8 days. - Other effects:
- scurf formation in one animal
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- All animals showed slight to well-defined erythema, and two animals after 1 resp. 24 hours slight edema. All animals were free of symptoms after 6 - 8 days.
1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters showed a slightly irritant effect on the skin of the test animals with a primary dermal irritation index (PDII) of 1.67/8. The average scores were as follows: Erythema: 1.56, Edema: 0.11 - Executive summary:
To test the acute skin irritant effect, 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was applied to shaven dorsal skin of rabbits. The product was administered undiluted, and the time of exposure in the patch test was 4 hours. The test was carried out in accordance with OECD guideline 404 (12 May 1981).
The test substance showed a slightly irritating effect (primary dermal irritation index (PDII): 1.67) on the skin of male rabbits. Mean Irritation scores derived from the respective erythema and edema scores for the 24, 48 and 72 hours observations were 1.56 (erythema) and 0.11 (edema).
Referenceopen allclose all
Individual skin reactions:
Skin Reaction |
Observation Time (following patch removal) |
Individual Scores -Rabbit Number and Sex |
Total |
||
73212 Male |
73213 Male |
73214 Male |
|||
Erythema/Eschar Formation |
Immediately |
0 |
0 |
0 |
( 0) |
1 Hour |
1 |
0 |
0 |
(1) |
|
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
( 0) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Edema Formation |
Immediately |
0 |
0 |
0 |
( 0) |
1 Hour |
0 |
0 |
0 |
( 0) |
|
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
( 0) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72-Hour Readings (S) 0 |
|||||
Primary Irritation Index (S/6) 0/6 =0.0 |
|||||
Classification NON-IRRITANT |
( ) = Total values not used for calculation of primary irritation index
Individual Body Weights and Body Weight Change:
Rabbit Number and Sex |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
Day 0 |
Day 3 |
||
73212 Male |
2.49 |
2.53 |
0.04 |
73213 Male |
2.59 |
2.67 |
0.08 |
73214 Male |
2.50 |
2.55 |
0.05 |
Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
1/2/1 |
0/1/0 |
24 h |
1/2/2 |
0/0/1 |
48 h |
1/2/2 |
0/0/0 |
72 h |
1/2/1 |
0/0/0 |
Average 24h, 48h, 72h |
1.56 |
0.11 |
Reversibility*) |
c. |
c. |
Average time (unit) for reversion |
8 days |
8 days |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 17 June 2013 to 27 June 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with OECD and EU Guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.13 to 2.64 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: Free access to food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon. UK
- Water: Free access to mains drinking water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 17 to 23 degrees C.
- Humidity (%): The humidity was set to achieve 30 to 70%.
- Air changes (per hr): At least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to 12 hours continous light (06:00 to 18:00) and 12 hours darkness.
IN-LIFE DATES: From: 17 June 2013 To: 27 June 2013 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1mL
- Concentration: 100%
The pH of the test item was determined prior to the commencement of the study and found to be as follows:
Undiluted as supplied: Immediately: pH 7.9
90% v/v aqueous preparation of the test item: immediately: pH 7.7, after 10 minutes: pH 7.8 - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: N/A
SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation (Draize, J.H, 1977).
TOOL USED TO ASSESS SCORE: light source from a standard opthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: This is corneal opacity score. Multiplied by area of cornea involved and by 5 to give total score ( max: 80)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: This is corneal opacity score. Multiplied by area of cornea involved and by 5 to give total score ( max: 80)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: This is corneal opacity score. Multiplied by area of cornea involved and by 5 to give total score ( max: 80)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 amd 72 hours (mean)
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Score is multiplied by 5 to give total score (max: 10)
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Score is multiplied by 5 to give total score (max: 10)
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Score is multiplied by 5 to give total score (max: 10)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 1.33
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Includes chemosis, redness and discharge scores. Score is multiplied by 2 to give total score (max: 20)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 1
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Includes chemosis, redness and discharge scores. Score is multiplied by 2 to give total score (max: 20)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 1.67
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Includes chemosis, redness and discharge scores. Score is multiplied by 2 to give total score (max: 20)
- Irritation parameter:
- other: conjunctival redness
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: conjunctival redness
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- other: conjunctival redness
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours (mean)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No corneal effects were noted during the study.
Iridial inflammation was noted in one treated eye at the 24 hour observation.
Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation noted in two treated eyes one hour after treatment. Minimal conjunctival irritation was noted in all treated eyes at the 24 hour and 48 hour observations.
All treated eyes appeared normal at the 72 hour observation. - Other effects:
- Slight body weight loss was noted in one animal and two animals showed expected gain in body weight during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item produced a maximum group mean score of 6.7 (at 1 hour observation) and was classified as mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. In accordance with the CLP regulation, the substance is not classified for eye irritation.
- Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit.
Results
A single application of the test item to the non-irrigated eye of three rabbits produced iridial inflammation and minimal to moderate conjunctival irritation. All treated eyes appeared normal at the 72-Hour observation.
Conclusion
The test item produced a maximum group mean score of 6.7 (at 1 hour observation) and was classified as mild irritant to the rabbit eye according to a modified Kay and Calandra classification system. In accordance with the CLP regulation, the substance is not classified for eye irritation.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-05-09 to 1989-05-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.0 - 2.2 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³ - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 h and 7 days after treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 72 hours
SCORING SYSTEM: according to Draize (Appraisals of the Saftey of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas 1959, page 51)
TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 72 hours after administration - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjuntivae (Redness): 0.0
- Conjuntivae (Chemosis): 0.0 - Other effects:
- DESCRIPTION OF LESIONS: 1 hour after application circumcorneal injections in all animals and mild discharge in one animal
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:
Cornea opacity: 0.0
Iris lesion: 0.0
Redness of conjuntiva: 0.0
Oedema of conjunctiva: 0.0
Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa. - Executive summary:
To test the acute irritant effect of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters on the eyes and mucosa, 0.1 cm³ of the liquid test substance was administered into the conjunctival sac of one eye of each of three male rabbits. After exposure for 72 hours, the eyes were washed out with warm physiological saline. The test was carried out according to OECD guideline 405 (12 May 1982).
The test showed that administration of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters caused no irritation reactions at cornea and iris. At the conjunctivae 1 hour after application circumcorneal injections in all animals and mild discharge in one animal were observed, after 24 hours all animals were free of symptoms.
The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:
Cornea opacity: 0.0
Iris lesion: 0.0
Redness of conjuntiva: 0.0
Oedema of conjunctiva: 0.0
Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa.
Referenceopen allclose all
Individual Scores and Individual Total Scores for Ocular Irritation:
Rabbit Number andSex |
73261Male |
73283Male |
73284Male |
|||||||||
IPR =0 |
IPR =0 |
IPR =0 |
||||||||||
Time After Treatment |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
CORNEA |
|
|
|
|
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
|
|
|
|
D |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x5) |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
|
|
|
A =Redness |
2 |
2 |
1 |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
0 |
B =Chemosis |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
C =Discharge |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
Score (A + B + C) x2 |
8 |
6 |
2 |
0 |
6 |
4 |
2 |
0 |
6 |
2 |
2 |
0 |
TotalScore |
8 |
11 |
2 |
0 |
6 |
4 |
2 |
0 |
6 |
2 |
2 |
0 |
Individual Total Scores and Group Mean Scores for Ocular Irritation:
Rabbit Number and Sex |
Individual Total Scores At: |
|||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
|
73261 Male |
8 |
11 |
2 |
0 |
73283 Male |
6 |
4 |
2 |
0 |
73284 Male |
6 |
2 |
2 |
0 |
Group Total |
20 |
17 |
6 |
0 |
Group Mean Score |
6.7 |
5.7 |
2.0 |
0.0 |
Individual Body Weights and Body Weight Change:
Rabbit Number and Sex |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
Day 0 |
Day 3 |
||
73261 Male |
2.64 |
2.63 |
-0.01 |
73283 Male |
2.13 |
2.15 |
0.02 |
73284 Male |
2.44 |
2.54 |
0.10 |
Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
24 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
0 |
0 |
Area effected |
- |
- |
- |
- |
Maximum average score (including area affected, max 110) |
0 |
0 |
2.67 |
0 |
Reversibility*) |
- |
- |
c. |
- |
Average time (unit) for reversion |
- |
- |
24 hours |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Acute skin and eye irritation studies with 1,2,4 -Benzenetricarboxylic acid, decyl octyl ester have been conducted in rabbits.
In the key study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was slightly irritating to the skin, the effects in the skin were fully reversible within 8 days. In a supporting study no skin irritation was found.
In the key study to test the acute irritant effect of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters on the eyes and mucosa, 0.1 cm³ of the liquid test substance was administered into the conjunctival sac of one eye of each of three male rabbits. After exposure for 72 hours, the eyes were washed out with warm physiological saline. The test was carried out according to OECD guideline 405 (12 May 1982).
The test showed that administration of 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters caused no irritation reactions at cornea and iris. At the conjunctivae 1 hour after application circumcorneal injections in all animals and mild discharge in one animal were observed, after 24 hours all animals were free of symptoms.
The following mean values, based on the results from the 24 -, 48 - and 72 hour-readings were calculated:
Cornea opacity: 0.0
Iris lesion: 0.0
Redness of conjuntiva: 0.0
Oedema of conjunctiva: 0.0
Based on the result of this study 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters was judged to be non irritating to eyes and mucosa.
In a supporting study the test item produced a maximum group mean score of 6.7 (at 1 hour observation) was slightly irritant.
Effects on skin irritation/corrosion: slightly irritating
Justification for classification or non-classification
The results of the skin and eye irritating studies show that 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters does not warrant classification according to Regulation (EC) No 1272/2008.
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