Registration Dossier
Registration Dossier
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EC number: 287-625-4 | CAS number: 85566-16-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Alcohols, C13-15-branched and linear
- EC Number:
- 287-625-4
- EC Name:
- Alcohols, C13-15-branched and linear
- Cas Number:
- 85566-16-1
- Molecular formula:
- C13 H27 OH - C15 H31 OH
- IUPAC Name:
- Alcohols C13-C15 branched and linear, reaction products of C12-C14 olefines
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C13 - C15 - Alkohol
- Physical state: colorless liquid
- Analytical purity: 99.3% alcohols (0.5% low boiling substances, 0.2% high boiling substances)
- Composition of test material, percentage of components: 29.5% i-C13-alcohol, 33% n-C13-alcohol, 19% i-C15-alcohol, 17.8% n-C15-alcohol
- Lot/batch No.: from continuous production
- Sustance number: 88/577
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach / Main, Germany
- Weight at study initiation: male: 3.2 kg; mean(females): 3.2 kg
- Housing: single
- Diet: Kliba 341, 4 mm, Klingentalmuehle, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study (same housing conditions as during the study)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- See observation period, no washing out conducted
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- SCORING SYSTEM: according to OECD 405 / Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: see table below for details
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Other effects:
- Pupil contraction in one animal 24 and 48 h after application.
Any other information on results incl. tables
Animal Number |
Evaluation Interval |
Corneal Opacity |
Area of Corneal Opacity |
Iris |
Conjunctivae |
||
Red |
SW |
DI |
|||||
1 2 3 |
1 hour |
0 0 0 |
0 0 0 |
0 0 0 |
2 2 2 |
0 0 0 |
2 3 2 |
1 2 3 |
24 hours |
0 0 0 |
0 0 0 |
0 0 0 |
1 1 0 |
0 0 0 |
0 0 0 |
1 2 3 |
48 hours |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
1 2 3 |
72 hours |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
0 0 0 |
1 2 3 |
ME |
0.0 0.0 0.0 |
0.0 0.0 0.0 |
0.3 0.0 0.3 0.0 0.0 0.0 |
|||
ME |
0.0 |
0.0 |
0.2 0.0 |
||||
Calculation of the mean according to 83/467/EEC criteria of July 29 th, 1983.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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