2,7-NAPHTHALENEDISULFONIC ACID 5-[[4-CHLORO-6-(ETHYLPHENYLAMINO)-1,3,5-TRIAZIN-2-YL]AMINO]-3-[[5-[(2,3-DIBROMO-1-OXOPROPYL)AMINO]-2-SULFOPHENYL]AZO]-4-HYDROXY-,SODIUM SALT

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 40508/A
- Batch No.: Roe TV 1P
- Storage conditions: below 5°C
- Expiration date: December 1997

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Ltd., Animal production, 4332 Stein / Switzerland
- Weight at study initiation: 213-260g
- Housing: individually in Macrolon cages type 3, with standard soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

- Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
- The test substance (4mL/kg bw) was evenly dispersed on the skin. It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic band. After 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the skin reaction was appraised repeatedly.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days, Signs and symptoms: daily for 14 days, Body weight: immediately before administration and on days 7 and 14.
- Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No symptoms were observed.

Gross pathology:

No deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was determined to be greater than 2000 mg/kg bw.

Executive summary:

In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Tif: RAI f (SPF) rats (5/sex) were administered the test substance (2000 mg/kg bw). The test substance was dissolved in water, applied on the skin and covered with a semi-occlusive dressing for 24 hours. The treated skin was washed after 24 hours and a 14 -day observation period followed. No mortality, no clinical signs, and no abnormalities were found on necropsy. Therefore, the toxicity of the test substance was estimated to be >2000 mg/kg bw.