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Registration Dossier
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EC number: 220-482-8 | CAS number: 2781-11-5
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: not irritating (eq. EPA OPP 81-5, K, Rel.12.
Eye irritation: not irritating (eq. OECD 405, K, rel.2).
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
- Study period:
- 15 Jul - 16 Dec 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 49, Part 173, Appendix II
- Version / remarks:
- 1977
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- 1978
- Deviations:
- yes
- Remarks:
- : no 72 h observation period
- Principles of method if other than guideline:
- - Principle of test: patch-test
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Receipt date: 25 Jun 1981
- Color: amber
- Form: viscous liquid - Species:
- rabbit
- Strain:
- other: Stauffland albino rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, USA - Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Reading time points: 4 and 48 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch of intact skin
- Type of wrap: gauze patch held in place with adhesive tape and wrapped with rubberized damming
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
- 4 and 48 h
SCORING SYSTEM:
- Method of calculation: as described by Draize (1965) - Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 4/48 hr
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No indication of irritation. The observation time points differs from the 24/48/72 standard, however since there was no irritation observed at 4 or 48 hours, this deviation would probably not alter the conclusion.
- Irritant / corrosive response data:
- No adverse effects were observed for all tested animals at the time points 4 and 48 h.
- Other effects:
- - Other adverse local effects: none
- Other adverse systemic effects: none - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material is not classified according to Regulation (EC) 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a primary dermal irritation study, conducted similarly to the EPA OPP 81-5 Guideline, six female Stauffland albinorabbits were dermally exposed to (0.5mL) of undiluted test material to the dorsal area of the trunk. Test sites were covered with an occlusive dressing for 4 hours. Skin reactions of the animals were assessed at removal of the patches and 48 hours after. Irritation was scored according to the Draize scale.
The test material produced no irritation in intact skin of albino rabbits.
Mean (4/48 hrs) individual erythema score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.
Mean (4/48 hrs) individual oedema score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.
Under the conditions of this study, the test material is not classified according to Regulation (EC) 1272/2008 (CLP) and to the GHS.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 Jul - 16 Dec 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- 1978
- Deviations:
- no
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Receipt date: 25 Jun 1981
- Color: amber
- Form: viscous liquid - Species:
- rabbit
- Strain:
- other: Stauffland albino rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, USA - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 µL
- Duration of treatment / exposure:
- 3 animals: 20-30 sec
6 animals: 7 d - Observation period (in vivo):
- 7 days with several reading time points (1, 2, 3, 4, and 7 d after treatment)
- Number of animals or in vitro replicates:
- 9 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 20-30 sec
SCORING SYSTEM: Draize guidelines (1965)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4, #5 & #6 (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #4, #5 & #6 (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #4, #5 & #6 (unwashed eye)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Redness of the conjunctiva which occured only in the test animals with unwashed eyes was observed at day one and two. This effect was fully reversible within 3 days in all animals and the average score (24/48/72 h) for the conjunctiva was not greater than or equal to 2.
- Other effects:
- - Effects of rinsing or washing: When rinsing the eye with water 20-30 sec after treatment, no irritation was observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material is not classified according to Regulation (EC) 1272/2008 (CLP) and to the GHS.
- Executive summary:
In a primary eye irritation study conducted similarly to OECD TG 405, 0.1 mL of undiluted test material was instilled into the conjunctival sac of one eyes of 9 female Stauffland albino Rabbits. On 3 of these animals the eye was washed with water 20-30 seconds after exposure, and on the remaining 6 animals the eyes were not washed. Irritation was scored according to the Draize scale.
Mean (24/48/72 hrs, unwashed eye) individual corneal opacity / iris / chemosis score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.
Mean (24/48/72 hrs, unwashed eye) individual conjunctiva score: 0.67 / 0.67 / 1.00 / 1.00 / 0.67 / 0.67.
Under the conditions of this study, the test material is not classified according to Regulation (EC) 1272/2008 (CLP) and to the GHS.
Reference
Table 1: Individual Draize scores and means (total scores) for 24 h, 48 h and 72 h
Animal number |
Irritation |
Pre-treatment |
Individual scores after |
Weighted total scores (mean) after |
|||||
24 h |
48 h |
72 h |
24 h |
48 h |
72 h |
||||
81-F-206 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
1 |
1 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
81-F-207 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
2 |
0 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
81-F-214 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
6 |
4 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
2 |
1 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
1 |
1 |
0 |
|||||
81-F-215 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
4 |
2 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
2 |
1 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
81-F-216 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
2 |
2 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
1 |
1 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
81-F-217 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
|||||
Iris |
0 |
0 |
0 |
0 |
|||||
Conjunctiva |
Redness |
0 |
1 |
0 |
0 |
||||
Chemosis |
0 |
0 |
0 |
0 |
|||||
Discharge |
0 |
0 |
0 |
0 |
|||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
A key study was identified (Miller and Morgan, 1983). The study was conducted similarly to the EPA OPP 81-5 Guideline.
The test material produced no irritation in intact skin of albino rabbits.
Mean (4/48 hrs) individual erythema score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.
Mean (4/48 hrs) individual oedema score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.
The test material is not a skin irritant under the test conditions.
Eye irritation.
A key study was identified (Miller and Morgan, 1983). The study was conducted similarly to OECD TG 405.
Mean (24/48/72 hrs, unwashed eye) individual corneal opacity / iris / chemosis score: 0.00 / 0.00 / 0.00 / 0.00 / 0.00 / 0.00.
Mean (24/48/72 hrs, unwashed eye) individual conjunctiva score: 0.67 / 0.67 / 1.00 / 1.00 / 0.67 / 0.67.
The test material is not an eye irritant under the test conditions.
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Based on the available information no additional self-classification is proposed regarding both skin and eye irritation according to the CLP and to the GHS.
No data was available regarding respiratory irritation, however the substance not being classified for skin and eye irritation, no classification is expected for respiratory irritation.
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.
