C.I. Acid Yellow 246

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 July 1984 to 29 August 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Code No: FAT 20306/B
Batch No.: HT 2025/50
Stability: 30 years
Description; solid
Contents of active ingredient approx. 96 %

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif x RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 192 - 215 g
- Fasting period before study: overnight
- Housing: They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding.
- Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) was provided ad libitum.
- Water: water was provided ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 55 ±15
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: 0l. arachidis Ph. H. VI Siegfried AG

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: 10 %
- Type of wrap if used: adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg hody weight

Duration of exposure:

24 h

Doses:

single dose of 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on working days, daily, a.m. and p.m. a.m. on weekends for mortaility; on days 1, 7, 14 and at death for body weight
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

From the body weights, the group means and their standard deviations were calculated. Where: feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Mortality:

No mortailty

Clinical signs:

other: Dyspnoea, exophthalmos, ruffled fur and abnormal body positions.

Gross pathology:

No tireatment-related deviations from normal morphology detected.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

An acute dermal median lethal dose (LD50) of FAT 20306/B to rat is greater than 2000 mg/kg bw.

Executive summary:

In an acute dermal study carried out with FAT 20306/B in rats according to OECD guideline 402, the test substance was applied to the skin of rats (5/sex) for 24 hrs at a dose of 2000 mg/kg. No mortality was observed at test concentration. No deviation from normal morphology at necropsy. No treatment-related deviations from normal morphology was detected in any animal. Dyspnoea, exophthalmus, ruffled fur and abnormal body positions were observed, but all rats had recovered within 12 days. Based on the study results, the LD50 of test substance was estimated to be greater than 2000 mg/kg bw.