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Registration Dossier
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EC number: 700-897-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982-04-26 to 1982-05-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Remarks:
- Study conducted in compliance with agreed protocols, with minor deviations from standard test guidelines, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.3- Federal Hazardous Substances Act Regulations - (16 CFR, 1500.42)
- GLP compliance:
- yes
Test material
- Reference substance name:
- bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] (2E)-but-2-enedioate
- EC Number:
- 700-897-5
- Molecular formula:
- C40H76O4
- IUPAC Name:
- bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] (2E)-but-2-enedioate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Fasting period before study: No
- Age at study initiation: 3 months of age
- Housing: stainless steel cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclaimation: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 65-75
- Photoperiod (hrs dark / hrs light): 12 /12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Eyes were not rinsed throughout study
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- 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:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- 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:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #6
- 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:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- 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:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
The individual ocular scores
Rabbit No. |
Day |
Cornea |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
||||
1 |
1 |
0 |
0 |
2 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
3 |
1 |
0 |
0 |
2 |
1 |
0 |
4 |
1 |
0 |
0 |
1 |
0 |
0 |
5 |
1 |
0 |
0 |
0 |
0 |
0 |
6 |
1 |
0 |
0 |
1 |
0 |
0 |
|
|
|
|
|
|
|
1 |
2 |
0 |
0 |
1 |
0 |
0 |
2 |
2 |
0 |
0 |
2 |
1 |
0 |
3 |
2 |
0 |
0 |
2 |
0 |
0 |
4 |
2 |
0 |
0 |
1 |
0 |
0 |
5 |
2 |
0 |
0 |
0 |
0 |
0 |
6 |
2 |
0 |
0 |
1 |
0 |
0 |
|
|
|
|
|
|
|
1 |
3 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
0 |
0 |
1 |
0 |
0 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
4 |
3 |
0 |
0 |
0 |
0 |
0 |
5 |
3 |
0 |
0 |
0 |
0 |
0 |
6 |
3 |
0 |
0 |
0 |
0 |
0 |
|
|
|
|
|
|
|
1 |
4 |
0 |
0 |
0 |
0 |
0 |
2 |
4 |
0 |
0 |
0 |
0 |
0 |
3 |
4 |
0 |
0 |
0 |
0 |
0 |
4 |
4 |
0 |
0 |
0 |
0 |
0 |
5 |
4 |
0 |
0 |
0 |
0 |
0 |
6 |
4 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.
- Executive summary:
Test Guidance
Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act,
Method and Material
0.1 mL of the test material was instilled into the right eye of six young adult Newzeland rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3 and 4 days following treatment. Interpretation of results was made in accordance with the Draize scale.
Results
No effects on the cornea or iris were observed in any animal at any observation period (all scores were 0). The average conjunctivae score was 0.89 at 24, 48 and 72 hour. The average chemosis score was 0.17 at 24, 48 and 72 hour. All observed effects were fully reversible in 4 days.
Conclusion
In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye 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.
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