Registration Dossier
Registration Dossier
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EC number: 205-571-1 | CAS number: 142-91-6
Eye irritation
Administrative data
- 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 with acceptable restrictions, basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited documentation, analytical purity of test substance not specified
- Principles of method if other than guideline:
- Protocol according to FHSA
- GLP compliance:
- no
Test material
- Reference substance name:
- Isopropyl palmitate
- EC Number:
- 205-571-1
- EC Name:
- Isopropyl palmitate
- Cas Number:
- 142-91-6
- Molecular formula:
- C19H38O2
- IUPAC Name:
- propan-2-yl hexadecanoate
- Details on test material:
- - Name of test material (as cited in study report): Isopropyl palmitate
- Name of test material (as cited in study report): Hexadecanoic acid, 1-methylethyl ester
- CAS No. of test material (as cited in study report): 142-91-6
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 1, 24, 48 and 72h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: no
SCORING SYSTEM: according to Draize scale for scoring ocular lesions
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects in any animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Remarks on result:
- other: no effects in any animal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- other: average 24, 48 and 72h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
Any other information on results incl. tables
Individual Scores:
Animal Number |
Hours after Application |
|||||||||||||||
1 |
24 |
48 |
72 |
|||||||||||||
A |
B |
C |
D |
A |
B |
C |
D |
A |
B |
C |
D |
A |
B |
C |
D |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
A = Cornea Score
B = Iris Score
C = Conjunctiva Score
D = Chemosis Score
After a single instillation the test substance causes mild irritations to rabbit eyes that were fully reversible within 72h. According to DSD and CLP the test substance has not to be classified.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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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