Registration Dossier
Registration Dossier
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EC number: 310-080-1 | CAS number: 102242-49-9 The complex residue resulting from the vacuum distillation of C6-24 fatty alcohols which is derived from hydrogenation of C6-24 fatty acids methyl esters. It consists predominantly of satd. fatty alcohols having carbon numbers greater than C18, dimerization products, and long chain esters having carbon numbers greater than C32 and boils at > 250°C (482°F) at 10 torr.
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:
- other: Study according to OECD test guideline 405 under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- Alcohols, C6-24, distn. residues
- EC Number:
- 310-080-1
- EC Name:
- Alcohols, C6-24, distn. residues
- Cas Number:
- 102242-49-9
- Molecular formula:
- Not available for this UVCB (see Remarks)
- IUPAC Name:
- Alcohols, C6-24, distn. residues
- Details on test material:
- - Name of test material (as cited in study report): C-SAT 100018
- Physical state: slightly yellowish solid
- Analytical purity: 100%
- Lot/batch No.: CF00460029
- Expiration date of the lot/batch:26.02.2011
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian Rabbit
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- 1h
- Observation period (in vivo):
- 72h
- 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: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Redness of score 1 (all three rabbits) and chemosis of score 1 (one rabbit) was observed after 1 hour.
- Other effects:
- none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a study according to OECD test guideline 405 under GLP, the test substance was not irrritating to the eye.
- Executive summary:
The eye irritation potential of the test substance was investigated in a study according to OECD test guideline 405.
The amount of 0.1g was applied to eyes of three Russian rabbits and washed out after 1 hour. After 1 hour, redness (score 1) was observed in all rabbits and chemosis of score 1 in one rabbit. No irritant reaction was present after 24, 48 and 72 hours in all rabbits. Therefore, the test substance is considered to be not irritating to the eye.
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