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Toxicological information

Eye irritation

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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:
2013
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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

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:
other: Severe irritating to eyes
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).