Registration Dossier
Registration Dossier
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EC number: 203-517-1 | CAS number: 107-74-4
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:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,7-dimethyloctane-1,7-diol
- EC Number:
- 203-517-1
- EC Name:
- 3,7-dimethyloctane-1,7-diol
- Cas Number:
- 107-74-4
- Molecular formula:
- C10H22O2
- IUPAC Name:
- 3,7-dimethyloctane-1,7-diol
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: DR . K . THOMAE GMBH, BIBERACH, FRG
- Age at study initiation: YOUNG ADULT ANIMALS
- Weight at study initiation: 3.00-3.38 kg
- Housing: single housing
- Diet (e.g. ad libitum): ABOUT 250 ML TAP WATER PER ANIMAL PER DAY
- Water (e.g. ad libitum): KLIBA-LABORDIAET 341, KLINGENTALMUEHLE AG, KAISERAUGST, SWITZERLAND, (ABOUT 130 G PER ANIMAL PER DAY)
- Acclimatization period: at least 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70 %
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: negative control: untreated eye
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 24 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1/24/48/72h and 8 d
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1/24/48/72h and 8d
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 1/24/48/72 h and 8 d
- Score:
- 2.1
- Max. score:
- 3
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- Due reversible of conjunctivae redness (score >=2) a classification of Category 2B is justified.
- Executive summary:
Three White New Zealand were subject to a single ocular application of 0.1 mL. The average score for irritation (24 h-72 h) was 0.3 for corneal opacity, 0.2 for iris, 2.1 for conjuntivae redness and 0.8 for chemosis. All effects were reversible within 8 d.
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