Isopropyl benzoate

Endpoint summary

Description of key information

Isopropyl benzoate is not irritating to the skin or eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

Pre-existing in vivo study.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to GLP, however, documentation is incomplete.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
No details on the test animals were provided in the report.

Type of coverage:

not specified

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

0.5 ml

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): None
VEHICLE: None

Duration of treatment / exposure:

4 hours. After 4 hours of exposure the skin was cleaned and decontaminated with water.

Observation period:

1 hr and 1, 2 and 3 days after exposure.

Number of animals:

Three

Details on study design:

- Area of exposure: Shaved flank
REMOVAL OF TEST SUBSTANCE
- Washing with water: Yes
- Time after start of exposure: 4 hrs
SCORING SYSTEM:
Draize scale

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: Mean scores calculated from 1, 2 and 3 day readings

Score:

0

Max. score:

4

Remarks on result:

other: No measurable erythema or edema

Irritant / corrosive response data:

There was no measurable irritation or corrosive response on three rabbits tested.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance was non-irritating following a single four hour application to rabbit skin. The test was conducted on three rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

no data

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
experimental data

Justification for selection of eye irritation endpoint:
experimental data

Justification for classification or non-classification

Considering that isopropyl benzoate is not irritating to the skin or eye of rabbits, and that is has a long history of safe use in cosmetic ingredients in the EU and other jurisdictions, the substance is not classified for irritation or corrosion, according to Regulation EC No. 1272/2008.