Bontron E-108

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 2000 ber 2000

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 relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: February 28th 2000, Date of signature: April 26th 2000

Test material

Test material information

Constituent 1

Details on test material:

Sponsor's identification :S178207
Description : white powder
Batch number : SBT-5-0254
Date received : 08 November 2000
Storage conditions :room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: ad libitum - STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water: ad libitum - mains drinking water
- Acclimation period: acclimatisation period of at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness


IN-LIFE DATES: From: Day of application (Day 0) To: Sacrifice (72 hours after application)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped free of fur

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 ml of distilled water
- Concentration (if solution): not applicable


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution):not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable

Duration of treatment / exposure:

Four hours

Observation period:

72 hours

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm patches
- % coverage: not stated in report
- Type of wrap if used: cotton gauze patch secured in position with a strip of surgical adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize, J.H. (1977) "Dermal and eye Toxicity Tests" In: Principles and Procedures for evaluating the toxicity of household Substances, National Academy of Sciences, Washington DC, p 31.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 12 Male

Time point:

other: Mean of 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No effects observed

Results 2

Irritation parameter:

erythema score

Basis:

animal: 13 Female

Time point:

other: Mean of 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No effects observed

Results 3

Irritation parameter:

erythema score

Basis:

animal: 19 Male

Time point:

other: Mean of 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No effects observed

Results 4

Irritation parameter:

edema score

Basis:

animal: 12 Male

Time point:

other: Mean of 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No effects observed

Results 5

Irritation parameter:

edema score

Basis:

animal: 13 Female

Time point:

other: Mean of 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No effects observed

Results 6

Irritation parameter:

edema score

Basis:

animal: 19 Male

Time point:

other: Mean of 24, 48 and 72 hours

Score:

0

Max. score:

0

Reversibility:

other: No effects observed

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study. No corrosive effects were noted.

Other effects:

None

Any other information on results incl. tables

No evidence of skin irritation was noted during the study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material did not meet the criteria for classification as irritant or corrosive according to EU or GHS labelling regulations. No symbol or risk phrase are required.

Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

§        OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 17 July 1992)

§        Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)

Results. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.

Conclusion. The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 93/21/EEC.