Registration Dossier
Registration Dossier
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EC number: 235-878-6 | CAS number: 13019-22-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 March 1982 - 9 March 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: recommended guideline for 'Acute Eye Irritation Testing', Interagency regulatory liaison group, CPSC, EPA, FDA, OSHA, January 1981
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Dec-9-en-1-ol
- EC Number:
- 235-878-6
- EC Name:
- Dec-9-en-1-ol
- Cas Number:
- 13019-22-2
- Molecular formula:
- C10H20O
- IUPAC Name:
- dec-9-en-1-ol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: caged individually in stainless steel cages
- Diet (e.g. ad libitum): standard rabbit maintenance feed, ad libitum
- Water (e.g. ad libitum): automatic drinking water supply
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12 hours/ day
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount: 0.1 mL
- Duration of treatment / exposure:
- Single application, a few seconds
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 out of 6 rabbits, the treated eye was flushed with physiological saline for about one minute.
- Time after start of exposure: approximately 30 seconds
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 7.6
- Max. score:
- 7.6
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- rinced
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- not rinced
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 14.7
- Max. score:
- 24.3
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Assessment of irritation:
0 to 10: none
11 to 25: slight
26 to 56: moderate
57 to 110: marked - Other effects:
- Rinsing the eyes following substance instillation practically abolished the action of the compound.
Any other information on results incl. tables
Effect of rinsing: 29.4
Scaling:
Less than 1 : rinsing increased the effect of the compound
1 : no effect
1.1 to 1.5 : practically no effect
1.6 to 2.0 : little but assessable effect
2.1 to 4.0 : good effect
4.1 to 10 : very good effect
Above 10 : action of the compound practically abolished
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of this experiment the test material was classified as Category 2.
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