Registration Dossier
Registration Dossier
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EC number: 270-700-0 | CAS number: 68476-80-2 Complex combination obtained by steam distillation of mixed vegetable oils followed by condensation of the steam. Contains fatty acids, sterols, aldehydes and ketones.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reviewed studies reported in European Chemicals Agency (ECHA) Committee for Risk Assessment (RAC) opinion, but with limited study details.
Data source
Reference
- Reference Type:
- publication
- Title:
- Annex 1: Background document to the opinion proposing harmonised classification and labelling at Community level of decanoic acid, EC number: 206-376-4; CAS number: 334-48-5
- Author:
- ECHA Committee for Risk Assessment (RAC)
- Year:
- 2 013
- Bibliographic source:
- CLH-O-0000002590-79-03/A1
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The eye irritation potential of octanoic and nonanoic acid were evaluated on the basis of two non-GLP studies conducted in rabbits (Smyth et al, 1962 and Briggs et al, 1976 cited in the ECHA RAC opinion).
- GLP compliance:
- not specified
- Remarks:
- This information is not available in the RAC opinion
Test material
- Reference substance name:
- Octanoic acid
- EC Number:
- 204-677-5
- EC Name:
- Octanoic acid
- Cas Number:
- 124-07-2
- Molecular formula:
- C8H16O2
- IUPAC Name:
- octanoic acid
- Reference substance name:
- Nonanoic acid
- EC Number:
- 203-931-2
- EC Name:
- Nonanoic acid
- Cas Number:
- 112-05-0
- Molecular formula:
- C9H18O2
- IUPAC Name:
- nonanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Octanoic acid and Decanoic acid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- not specified
- Number of animals or in vitro replicates:
- Smyth et al., 1962 study: 5 rabbits per group
Briggs et al., 1976 study: no information available
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Corneal effects
- Basis:
- mean
- Time point:
- other: not specified
- Score:
- ca. 9
- Max. score:
- 10
- Reversibility:
- not specified
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: No details provided
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the studies, the substances were considered to cause severe damage to the eyes.
- Executive summary:
Two non-GLP studies were conducted to evaluate the eye irritation potential of the constituent fatty acids octanoic and decanoic acids in rabbits. One of the study (by Smyth et al, 1962 cited in ECHA RAC, 2013) conducted in 5 rabbits per group resulted in grade 9 corneal effects, indicating risk for severe damage to the eye for both octanoic and decanoic acid. No information on the concentration or on the reversibility was provided. The other study (by Briggs et al, 1976 cited in ECHA RAC, 2013) revealed corneal opacity, with no reversibility over up to 72 h. No information on the number of rabbits or on the concentrations of the substances was provided and no scoring was applied. Overall, under the conditions of the studies, both the substances were considered to cause severe damage to the eyes (ECHA, RAC, 2013).
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