Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Fragrance material review on isoamyl salicylate
Author:
A. Lapczynski , L. Jones, D. McGinty, S. Bhatia, C.S. Letizia, A.M. Api
Year:
2007
Bibliographic source:
Food and Chemical Toxicology 45 (2007) S418–S423

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
An eye irritation study of isoamyl salicylate (CAS No: -87-20-7)was conducted on rabbits.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopentyl salicylate
EC Number:
201-730-4
EC Name:
Isopentyl salicylate
Cas Number:
87-20-7
Molecular formula:
C12H16O3
IUPAC Name:
3-methylbutyl 2-hydroxybenzoate
Constituent 2
Reference substance name:
isopentyl salicylate (Synonym: isoamyl salicylate)
IUPAC Name:
isopentyl salicylate (Synonym: isoamyl salicylate)
Test material form:
liquid
Details on test material:
Chemical Name: isopentyl salicylate (Synonym: isoamyl salicylate)
Molecular Formula:C12H16O3
Molecular Weight: 208.26 g/mol
Nature of chemical: Organic
Physical State: Liquid
Specific details on test material used for the study:
Chemical Name: isopentyl salicylate (Synonym: isoamyl salicylate)
Molecular Formula:C12H16O3
Molecular Weight: 208.26 g/mol
Nature of chemical: Organic
Physical State: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
15% or 100%
Duration of treatment / exposure:
No Data
Observation period (in vivo):
No Data
Number of animals or in vitro replicates:
Six rabbits
Details on study design:
TEST SITE
- Area of exposure: lower eyelids of rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0
Remarks on result:
other: 15% isoamyl salicylate, no irritation observed
Irritation parameter:
overall irritation score
Basis:
mean
Score:
0
Remarks on result:
other: 100% isoamyl salicylate, irritation observed in 1 of 6 rabbits
Irritant / corrosive response data:
No irritation was observed with 15% isoamyl salicylate when instilled in the lower eyelids of rabbit. Irritation though was observed in 1 rabbit with neat isoamyl salicylate.
Other effects:
No data

Any other information on results incl. tables

No irritation was observed with 15% isoamyl salicylate when instilled in the lower eyelids of rabbit. Irritation though was observed in 1 rabbit with neat isoamyl salicylate.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
An eye irritation study of isoamyl salicylate was conducted on rabbits. No irritation was observed with 15% isoamyl salicylate. Irritation though was observed in 1 rabbit with neat isoamyl salicylate. Thus, under the conditions of the test, isoamyl salicylate was not considered to be a primary eye irritant.
Executive summary:

An eye irritation study of isoamyl salicylate(CAS No: -87-20-7)was conducted on rabbits. 15% and 100% isoamyl salicylate was instilled into the lower eyelids of 6 rabbits. No irritation was observed with 15% isoamyl salicylate. Irritation was observed in 1 rabbit with neat(100%) isoamyl salicylate. Thus, under the conditions of the test, isoamyl salicylate(CAS No: -87-20-7)was not considered to be a primary eye irritant.