C.I. Acid Yellow 246

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 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 401 (Acute Oral 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: Rat, 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: 178 - 202 g
- Fasting period before study: overnight
- Housing: They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bed-ding.
- 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

Route of administration:

oral: gavage

Vehicle:

other: 01. arachidis Ph. H. VI Siegfried AG

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg body weight
- Rationale for the selection of the starting dose: 5000 mg/kg bw

Doses:

one single dose of 5000 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: 1, 7 and 14 day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Statistics:

From the body weights, the group means, and their standard deviations were calculated. Where feasible, 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:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality found

Mortality:

No mortality

Clinical signs:

other: Dyspnoea, exophthalmos, ruffled fur, and curved body position and a slight diarrhoea were observed. However, the animals recovered within 13 days.

Gross pathology:

No gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute oral median lethal dose (LD50) of FAT 20306/B is determined to be greater than 5000 mg/kg bw.

Executive summary:

In an acute oral toxicity study carried out with FAT 20306/B in rats according to OECD guideline 401, the test article was administrated to rats (5/sex) by oral gavage at one single dose of 5000 mg/kg. No mortality was observed. Dyspnoea, exophthalmus, ruffled fur, and curved body position and a slight diarrhoea were observed . However, the animals recovered within 13 days. No gross organ changes were observed. Based on the study results, acute oral median lethal dose (LD50) of FAT 20306/B is determined to be greater than 5000 mg/kg bw.