Benzene, poly(propene) derivatives

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): AL305B
- Physical state: clear, colourless, slightly viscous liquid
- Lot/batch No.: TS07003
Analytical purity: 100%
Expiry date: 01 March 2008
Storage: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, Tennessee
- Age at study initiation: 10 weeks of age
- Weight at study initiation: 2.4-2.6 kg prior to dosing
- Housing:
- Diet (e.g. ad libitum): PMI Certified Rabbit Chow #5322 (PMI Nutrition International) ad libitum
- Water (e.g. ad libitum): municipal tap water ad libitum
- Acclimation period: minimum of five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22 °C
- Humidity (%): 53-69
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

4 hours

Observation period:

Up to 7 days after patch application

Number of animals:

3 rabbits

Details on study design:

Removal of test material: gauze moistened with mineral oil, USP, followed by dry gauze, followed by gauze moistened with distilled water, followed by a dry gauze.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 hours

Score:

1.11

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0

Any other information on results incl. tables

Exposure to the test article produced slight to well-defined erythema and very slight edema at 3/3 test sites by the 1-hour scoring interval. The dermal irritation resolved completely at 3/3 test sites by the day 7 scoring interval.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the conditions of the test, the test substance is not considered to be a skin irritant.

Executive summary:

Each of three New Zealand white rabbits received a 0.5 ml dose of the test substance as a single dermal application. The dose was held in contact with the skin under a semi-occlusive binder for approximately 4 hours. Following the exposure period, the binder was removed and remaining test substance wiped from the skin using gauze moistened with mineral oil followed by a dry gauze moistened with deionised water and a dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 7 days following patch application.

Exposure to the test substance produced slight to well-defined erythema and very slight edema at 3/3 test sites by the 1-hour scoring interval. The dermal irritation resolved completely at 3/3 test sites by the day 7 scoring interval.

Based on the results of this study, the Primiary Irritation Index for AL305B was determined to be 1.50.