[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read across from supporting substance

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

Study conducted before 1981

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Blue 158

IUPAC Name:

Acid Blue 158

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7 weeks
- Weight at study initiation: 192 g (♂) and 151 g (♀).
- Housing: Rats were caged singly
- Diet: A commercial pelleted diet ad libitum
- Water: ad libitum
- Fasting period before study: 18 hours

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: a 25 % (w/v) suspension of the compound in tap water.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
Deaths and clinical symptoms wars recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the 14 day observation period.

Clinical signs:

other: No clinical symptoms were recorded

Gross pathology:

At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation (EC n. 1272/2008)

Conclusions:

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

Executive summary:

The substance has been tested for acute toxicity after oral exposure, the test item was administered by gavage in a single dose of 5000 mg/kg bw to rats (5 male and 5 female).

After the administration, the animals were observed for 14 days. No deaths occurred and no clinical symptoms were recorded.

The acute oral median lethal dose LD50 of test item in rats is greater than 5000 mg/kg bw.