Registration Dossier
Registration Dossier
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EC number: 266-367-6 | CAS number: 66455-17-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.02.1981-11.02.1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a protocol that is comparable to current guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- yes
Test material
- Reference substance name:
- Alcohols, C9-11
- EC Number:
- 266-367-6
- EC Name:
- Alcohols, C9-11
- Cas Number:
- 66455-17-2
- Molecular formula:
- CnH(2n+2)O n= 9..11
- IUPAC Name:
- Alcohols C7-C9
- Details on test material:
- - Name of test material (as cited in study report): C9-11 alcohols Cas# 66455-17-2 (Neodol 91) 84% linear monobranched at the 2 position
- Physical state: clear 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: Camm Research Institute, USA
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: Individually housed in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 20.9C
- Humidity (%): average 56.3
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 0.5 minute(s)
- Observation period (in vivo):
- 7 days (examination points at 1, 24, 48 and 72 hours and at 7 days)
- Number of animals or in vitro replicates:
- 3M+3F unrinsed; 3M rinsed.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize, 1963 plus Kay & Callandra 1962 (modified)
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- other: nonwashed eyes
- Time point:
- other: 24 hours
- Score:
- 8.8
- Max. score:
- 110
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0.17
- Max. score:
- 0.67
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0.5
- Max. score:
- 0.67
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: unrinsed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72h
- Score:
- 0.39
- Max. score:
- 1.3
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- AVERAGE SCORE (24+48+72 hour) rinsed
- Cornea: individual scores all 0 (group mean score 0)
- Iris: Individual scores all 0 (group mean score 0)
- Conjunctivae (Redness): individual scores 0.3, 0, 0.3 (group mean score 0.2) -
Conjunctivae (Chemosis): individual scores 0.3, 0, 0.3 (group mean score 0.2)
- Overall irritation score: Maximum mean total score 4.7 at 1 hours after instillation.
All scores were 0 at 7 days both rinsed and unrinsed. - Other effects:
Conjunctival discharge reported in some rabbits up to 48 hours post instillation (unrinsed) and 1 hour after instillation (rinsed).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Neodol 91 is not an eye irritant by either EU or GHS criteria.
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