Direct Yellow 169

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: Guideline- and GLP-compliant 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))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): FAT 40'403/A
- Physical state: red solid

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. Wolferstrasse 4 CH-4414 Fullinsdorf
- Age at study initiation: males: 10 weeks; females: 12 weeks
- Weight at study initiation: males: 216 - 247 g; females: 194 - 210 g
- Fasting period before study: no data
- Housing: Individually in Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch 70/90 rat maintenance diet ("Kliba",
Klingentalmuehle AG, CH-4303 Kaiseraugst) ad libitum
- Water (e.g. ad libitum):Community tap water from Itingen, 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 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: 10


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with lukewarm tap water, dried with disposable paper towels
- Time after start of exposure:Twenty-four hours after the application


VEHICLE
- Amount(s) applied (volume or weight with unit):4 ml at 2000 mg/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg

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 / Viability: Four times during test day 1, and daily during days 2 - 15.
Body Weights: Test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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

Mortality:

none

Clinical signs:

males: skin/fur: skin yellow (back)
erythema focal (back)
females - skin/fur: skin yellow (back)

Body weight:

not affected

Gross pathology:

not affected

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not acute toxic via dermal application.