N-(trans-4-Hydroxycyclohexyl)-3,5-dibromo-2-hydroxybenzylidenamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13.05.2003 - 03.06.2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study procedures described in this report meet or exceed the requirements of the following guidelines: Directive 92/69 EEC, 8.4. "Acute Toxicity - Skin Irritation", July 31 , 1992. OECD Guidelines for Testing of Chemicals, Section 4, number 404 "Acute Dermal irritation / Corrosion", adopted April 24, 2002.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dibromo-6-({[(1r,4r*)-4-hydroxycyclohexyl]imino}methyl)phenol

EC Number:

924-083-6

Molecular formula:

C13 H15 Br2 N O2

IUPAC Name:

2,4-dibromo-6-({[(1r,4r*)-4-hydroxycyclohexyl]imino}methyl)phenol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): NA 1523
- Physical state: Yellow powder
- Lot/batch No.: 03020182
- Expiration date of the lot/batch: August 2003
- Storage condition of test material: at room temperature, away from direct sunlight.

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, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: 8-9 weeks(females), 10 weeks(males)
- Weight at study initiation: 1971-2026g
- Housing: stainless steel cages
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum
- Acclimation period: Under Iabaratory conditions after health examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C,
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g moistened with approximately 0.1 ml of purified water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: (ca. 4 cm x 4 cm)
- Type of wrap if used: gauze patch covered with a semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm tap water
- Time after start of exposure: 1, 24, 48 and 72 hours after the removal of gauze patch

SCORING SYSTEM:
EEC Commission Directive 92/69/EEC, July 31, 1992

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

animal: all 3 animals

Time point:

other: 1h, 24h, 48h, 72 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based upon the referred classification criteria (Commission Directive 2001 /59/EC of
August 06, 2001 ), NA 1523 is considered tobe "not irritating" to rabbit skin.

Executive summary:

The primary skin irritation potential of NA 1523 was investigated according to OECD test

guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to

the intact left flank of each of three young adult New Zealand White rabbits. The duration of

treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and

72 hours, as weil as 7, 10 and 14 days afterremoval of the dressing.

The test item did not elicit any skin reactions at the application site of any animal at any of

the observation times (all scores 0), except slight yellow staining. The individual mean score

for erythemaleschar and oedema for each of the three animals was therefore 0.

The test item caused slight yellow staining of the treated skin which persisted in one animal

up to the end of the Observation time. No corrosive effects were noted on the treated skin of

any animal at any of the measuring intervals and no other clinical signs of substance related

effects were observed.

Thus, the test item did not induce significant or irreversible darnage to the skin.

Based upon the referred classification criteria (Commission Directive 2001 /59/EC of

August 06, 2001 ), NA 1523 is considered tobe "not irritating" to rabbit skin.