Registration Dossier
Registration Dossier
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EC number: 208-759-1 | CAS number: 540-84-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observation day past 7 days post exposure not planned
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- Observation day past 7 days post exposure not planned
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2,4-trimethylpentane
- EC Number:
- 208-759-1
- EC Name:
- 2,2,4-trimethylpentane
- Cas Number:
- 540-84-1
- Molecular formula:
- C8H18
- IUPAC Name:
- 2,2,4-trimethylpentane
- Details on test material:
- - Name of test material (as cited in study report): Isooctane
- Analytical purity: 100% pure commercial product
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animals served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single treatment
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
SCORING SYSTEM: Draize scale for scoring ocular lesions
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: female rabbit
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritant / corrosive response data:
- Conjunctival redness (grade 2) was noted in four rabbits at 1 hour post instillation and persisted in one rabbit to 24 hours. The redness reversed by 48 hours. No corneal opacity, iritis, conjunctival chemosis, or discharge was noted in any of the six rabbits.
- Other effects:
- No effects.
Any other information on results incl. tables
The initial protocol did not include provision for 21-day observation, but it was not necessary as all irritation reversed by 48 hours after instillation, which is acceptable per current protocols.
The test substance was not irritating to the eyes according to the criteria of the EU and the GHS.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Remarks:
- Criteria used for interpretation of results: other: GHS, EU, 2007
- Conclusions:
- Based on the study design the test substance, 2,2,4-trimethylpentane, is not irritating.
- Executive summary:
Based on the study design the test substance, 2,2,4 -trimethylpentane, is not irritating.
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