2-isopropoxyethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

Study reported in sufficient detail to be able to judge it as reliable in contributing to the understanding of the skin irritancy properties of this substance. No individual animal data available. Not to GLP

Data source

Reference

Reference Type:

publication

Title:

Experimental study of cutaneous tolerance to glycol ethers

Author:

Zissu D

Year:

1995

Bibliographic source:

Contact Dermatitis, 32, 74-7

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-isopropoxyethanol

EC Number:

203-685-6

EC Name:

2-isopropoxyethanol

Cas Number:

109-59-1

Molecular formula:

C5H12O2

IUPAC Name:

Propan-2-ol

Details on test material:

Purity: 99%, verified by GC
Supplier : Merck

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ‘Elevage Scientifique des Dombes’ (Ain, France)
- Housing: housed individually.
- Diet (e.g. ad libitum): Food available ad libitum.
- Water: available ad libitum


ENVIRONMENTAL CONDITIONS
- Humidity (%): 55%+/-5
- Photoperiod (hrs dark / hrs light): 12hr light/dark cycle.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved for main test. Abraded and non abraded skin used for second test to Draize protocol

Vehicle:

unchanged (no vehicle)

Controls:

other: a number of other glycol ethers were examined in the study.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 100%:

Duration of treatment / exposure:

4 hours (24 for Draize experiment)

Observation period:

3 weeks

Number of animals:

3 for EC method and 6 in Draize protocol experiment

Details on study design:

TEST SITE
- Area of exposure: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: Draize (0-4 for erythema and odema) but using the EU assessment criteria. Subsequent test to Draize test protocol used primary irritation index.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72hrs

Score:

4.8

Max. score:

8

Remarks on result:

other: Sum of 24 and 72 hour observations for both abraded and non abraded skin

Remarks:

Data for individual animals not available in published report

Irritant / corrosive response data:

Main test: irritating
Draize protocol test: severely irritating.

Other effects:

none reported

Any other information on results incl. tables

Primary irritation index result would suggest severe erythema and oedema in some animals.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Data suggests that the substance is irritating in its own right, without taking into account persistence. Whilst individual animal data is not available, a result of >4 for the PII strongly suggests that the criteria for classification will be met. This was also the conclusions of the authors.

Executive summary:

In a reasonably well reported study in rabbits carried out to an EU guideline for irritancy testing, 2 -isopropoxyethanol showed moderate signs of irritation to the skin. The reported primary irritation index (which resulted from a study using abraded and intact skin) was 4.8, which suggested that the animals produced reactions of Draize levels 2 -3 (well defined to marked erythema and slight to moderate odema). Overall, this study indicates that the substance is meets the criteria for classification as a skin irritant in the EU based on the criteria of the CLP regulation.

Synopsis:

Irritating