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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation, other
Remarks:
Pre-existing in vivo study.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Experimental studies were performed in a reliable research institute prior to establishment of international guidelines and GLP

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Range-Finding toxicity Data: List IV
Author:
Smyth, Jr. H.F.
Year:
1951
Bibliographic source:
Arch. Ind. Hyg. Occup. Med. 4: 119-122
Reference Type:
review article or handbook
Title:
Safety assessment of alkyl benzoates as used in cosmetics
Author:
Becker LC, Bergfeld WF, Belsito DV, et al.
Year:
2012
Bibliographic source:
Int. J. Toxicol. 31:342S-72S

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Precedes establishment of guideline and GLP. It is assumed that this scientific study was performed according to the accepted standards of its day.
GLP compliance:
no
Remarks:
Precedes establishment of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl benzoate
EC Number:
213-361-6
EC Name:
Isopropyl benzoate
Cas Number:
939-48-0
Molecular formula:
C10H12O2
IUPAC Name:
propan-2-yl benzoate
Constituent 2
Reference substance name:
propan-2-yl benzoate
IUPAC Name:
propan-2-yl benzoate
Test material form:
other: liquid
Details on test material:
no data

Test animals / tissue source

Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
no data

Test system

Amount / concentration applied:
5 microliters
Observation period (in vivo):
24 h after instillation
Number of animals or in vitro replicates:
5
Details on study design:
Five albino rabbits are selected. Prior to administering the test material, the animals are selected based on an absence of grossly visible staining in the eye by a 5% aqueous solution of fluorescein sodium, flushed with distilled water 20 seconds after application. After a two hour interval allowing the eye to return to normal, 0.005 ml of undiluted material is administered while the eye lid is retracted; about 1 minute later, the lids are released. Assessment of injury occurs 18-24 hours after administration, in strong diffuse daylight and then in an examination aided with fluorescein. The injury is then scored. A level of 5 (of 20) is representative of severe injury, corresponding to necrosis covering about 75% of cornea or a smaller area of more severe necrosis. Guided by the result and the table of injury grades, additional applications are made. The average injury score per animal is divided by 5 (number of animals) and assigned a grade. If dilution of a chemical is necessary, the preferred solvent is propylene glycol, and then water.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
non-standard scale
Basis:
mean
Time point:
other: 24 h after application
Score:
1
Max. score:
20
Reversibility:
not specified
Remarks on result:
other: low irritation
Irritant / corrosive response data:
Using a non-standard scale to evaluate eye irritation, the score was 1 (of 20 maximum) at 24 h after application of IPB.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Using a non-standard scale to evaluate eye irritation in rabbits, the score was 1 (of 20 maximum) at 24 h after application of IPB.