C.I. Reactive Blue 230

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

1985

Report date:

1985

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 40181/B
- Batch No.: UO-1131/85
- Expiration date: January 1, 1995
- Stability of test article: Stable
- Stability of test article dilution: stable for at least 2 hours

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf, Switzerland
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: Males: 246 - 263 g, Females: 208-260 g
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz, Switzerland).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch 22/85 rat maintenance diet ("Kliba", Klingentalmuehle AG, Kaiseraugst, Switzerland), available ad libitum.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum.
- Acclimation period: One week under laboratory conditions, after veterinary examination

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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

4% in distilled water

Details on dermal exposure:

Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 20 square centimeters. On test day 1, 4 mL of the test article was applied evenly on the skin and covered with an occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Twenty-four hours after the application, the dressing was removed and the skin reaction was assessed according to the method of Noaks and Sanderson (Noaks, D.N. and Sanderson, D.M. "A Method for Determining the Dermal Toxicity of Pesticides". Brit. J. Industr. Med., 26, 59-64, 1969).

Duration of exposure:

24 hours under an occlusive dressing and open for an additional 14 days, because the skin was not washed when the dressing was removed.

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
- Mortality/viability were measured four times during test day 1 and daily during days 2 - 15.
- Body weights were measured on day 1 (pre administration), 8 and 15.
- All animals were necropsied.
- Each animal had an examination for changes in appearance and behavior four times during day 1, and daily during days 2-15 (general behaviour, respiration, eye, nose, motility, body position, motor susceptibility, skin), gross pathology.

Statistics:

The Logit model could not be applied to the observed rate of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

0%

Clinical signs:

other: Necrosis, at termination of observation, the animals had not recovered from the described local symptoms.

Gross pathology:

No macroscopic organ changes were observed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance was estimated to be greater than 2000 mg/kg bw

Executive summary:

In a GLP compliant dermal toxicity study, performed according to OECD guideline 402, Wistar rats (5/sex) were administered test substance (2000 mg/kg bw). The test substance was dissolved in a 4 % CMC solution and applied on the skin and covered with an occlusive dressing for 24 hours. After 24 hours, a 14-day observation period followed. No mortality and no macroscopic organ changes were observed during this period. Necrosis was observed of which the animals did not recover before the end of the observation period. Therefore, the LD50 of the test substance was estimated to be >2000 mg/kg bw.