Disodium 7-[[2-(acetylamino)-4-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]azo]naphthalene-1,3-disulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 05th to 26th, 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted May 12, 1981

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Yellow 125

IUPAC Name:

Reactive Yellow 125

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 213 - 227 g; females 179 - 196 g.
- Fasting period before study: animals were fasted for 12 to 18 hours. Food was again presented approximately one hour after dosing.
- Water: ad libitum.
- Acclimation period: 7 days.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

- Application volume: 20 ml
- Vehicle: 4 % solution of CMC.
- Preparation: a weight by volume dilution was prepared using a homogenizer. Homogenicity of test article in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made immediately prior to dosing.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3 males and 3 females

Details on study design:

- Duration of observation period following administration: 14 days

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:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths occurred during the test

Clinical signs:

other: Sedation, ruffled fur were recorded; rats has recovered within 2 observation days.

Gross pathology:

No macroscopic organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) 1272/2008

Conclusions:

LD50 (female and male) > 5000 mg/kg bw

Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the KFM-Han. Wistar rat. The method followed the OECD Guidelines No. 401. A group of three fasted females and three fasted males was treated with the test material at a dose level of 5000 m/kg bw. The test material was administered orally in 4 % solution of CMC. Clinical signs were recorded over the 14 days observation period.

No deaths occurred during the test. Sedation, ruffled fur were recorded; rats has recovered within 2 observation days. No macroscopic organ changes were observed.

The acute oral median lethal dose (LD50) of the test material, in the rat, was estimated as being greater than 5000 mg/kg bodyweight.

Conclusion

LD50 (female and male) > 5000 mg/kg bw