Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 276-171-2 | CAS number: 71902-01-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: CFR 16, 1500.42
- GLP compliance:
- no
Test material
- Reference substance name:
- Sorbitan, isooctadecanoate
- EC Number:
- 276-171-2
- EC Name:
- Sorbitan, isooctadecanoate
- Cas Number:
- 71902-01-7
- Molecular formula:
- C23H48O8
- IUPAC Name:
- 2-(3,4-dihydroxyoxolan-2-yl)-2-hydroxyethyl 3-methylheptadecanoate
- Details on test material:
- - Name of test material (as cited in study report): Only trade name given
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino rabbit, not further specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- assumption, since according to followed guideline liquids are applied undiluted
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 7 days, reading timepoints: 1, 2, 3, 4 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.72
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.056
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
Any other information on results incl. tables
Table 1: Numerical scores awarded to the cornea reactions elicited by the test substance.
Animal No. |
Evaluation after |
Positive responder ? |
|||||
24 h |
48 h |
72 h |
4 d |
7 d |
Ø-score≥3 |
Ø-score≥1 |
|
1 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
2 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
3 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
4 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
5 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
6 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
Effects are reversible. Cut-off values according to CLP.
Table 2: Numerical scores awarded to the iris reactions elicited by the test substance.
Animal No. |
Evaluation after |
Positive responder ? |
|||||
24 h |
48 h |
72 h |
4 d |
7 d |
Ø-score≥1.5 |
Ø-score≥1 |
|
1 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
2 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
3 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
4 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
5 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
6 |
0 |
0 |
0 |
0 |
0 |
no |
no |
Ø 24h/48h/72h = 0 |
|
|
|||||
Effects are reversible. Cut-off values according to CLP.
Table 3: Numerical scores awarded to conjunctiva erythema elicited by the test substance.
Animal No. |
Evaluation after |
Positive responder ? |
||||
24 h |
48 h |
72 h |
4 d |
7 d |
Ø-score≥2 |
|
1 |
1 |
1 |
1 |
0 |
0 |
no |
Ø 24h/48h/72h = 1 |
|
|
||||
2 |
1 |
1 |
0 |
0 |
0 |
no |
Ø 24h/48h/72h = 0.67 |
|
|
||||
3 |
1 |
1 |
1 |
0 |
0 |
no |
Ø 24h/48h/72h = 1 |
|
|
||||
4 |
1 |
1 |
0 |
0 |
0 |
no |
Ø 24h/48h/72h = 0.67 |
|
|
||||
5 |
1 |
1 |
0 |
0 |
0 |
no |
Ø 24h/48h/72h = 0.67 |
|
|
||||
6 |
1 |
0 |
0 |
0 |
0 |
no |
Ø 24h/48h/72h = 0.33 |
|
|
||||
Effects are reversible. Cut-off values according to CLP.
Table 4: Numerical scores awarded to conjunctiva chemosis elicited by the test substance.
Animal No. |
Evaluation after |
Positive responder ? |
||||
24 h |
48 h |
72 h |
4 d |
7 d |
Ø-score≥2 |
|
1 |
0 |
0 |
1 |
0 |
0 |
no |
Ø 24h/48h/72h = 0.33 |
|
|
||||
2 |
0 |
0 |
0 |
0 |
0 |
no |
Ø 24h/48h/72h = 0 |
|
|
||||
3 |
0 |
0 |
0 |
0 |
0 |
no |
Ø 24h/48h/72h = 0 |
|
|
||||
4 |
0 |
0 |
0 |
0 |
0 |
no |
Ø 24h/48h/72h = 0 |
|
|
||||
5 |
0 |
0 |
0 |
0 |
0 |
no |
Ø 24h/48h/72h = 0 |
|
|
||||
6 |
0 |
0 |
0 |
0 |
0 |
no |
Ø 24h/48h/72h = 0 |
|
|
||||
Effects are reversible. Cut-off values according to CLP.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
