JAUNE REACTIF 181

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 April 1990 to 19 April 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

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 40'400/A
- Lot/batch No.: BG 3247/TV 6
- Expiration date of the lot/batch: March 1995
- Stability: Stable
- Stability of test article dilution: at least 2 hours

Specific details on test material used for the study:

Identification Code: FAT 40400/A
Batch No.: BG 3247/TV6
Appearance: red solid
Purity: 84 %
Solubility (in water): a.100 g/l
Storage: room temperature
Stability: 03/95

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 9 weeks, females, 11 weeks
- Weight at study initiation: males: 218 - 243 g, females: 194 - 206 g
- Housing: Individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batches 67/90 and 68/90 rat maintenance diet ("Kliba" Klingentalmuehle AG, CH-4303 Kaiseraugst, available ad libitum
- Water: Community water from Itingen, available ad libitum
- Acclimation period: One week under laboratory conditions, after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10 % of the total body surface. On test day 1, 4 mL at 2000 mg/kg test article was applied evenly on the skin with a syringe and covered with a semi-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. The treated skin was washed with lukewarm tap water and dried with disposable paper towels and the skin reaction was assessed.

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
- Mortality/viability were measured four times during test day 1 (pre-administration) and daily during days 2 - 15.
- Body weights were measured on day 1, 8 and 15.
- All animals were necropsied.
- Each animal had an examination for changes in appearance and behaviour four times during day 1, and daily during days 2-15. All abnormalities were recorded.

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:

No deaths occured

Clinical signs:

other: - skin/fur: scales (back), skin yellow (back). Scales and discoloration were observed until termination of the study. - No systemic symptoms were observed in the animals during the study.

Gross pathology:

No macroscopic organ findings were observed in the animals.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of FAT 40400/A was estimated to be >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 FAT 40400/A at the dose of 2000 mg/kg bw. The test substance was dissolved in water and applied on the skin with a syringe 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 was observed during this period. Scales and discoloration were observed until termination of the study. No macroscopic findings were noted. Therefore, the acute dermal median lethal dose (LD50) of FAT 40400/A was estimated to be >2000 mg/kg bw.