Reaction products of 1-naphtylamino-5-sulfonic acid, 1,3-diaminobenzene and 4,4'-dinitrostilbene-2,2'-disulfonic acid, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed not in GLP and no guideline is reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Administrationof a single dose of the substance to rats by gavage.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Brown 238

IUPAC Name:

Acid Brown 238

Test material form:

solid: particulate/powder

Details on test material:

The substance was suspended in tap water before the administration.

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: aged 7 weeks
Weight at study initiation: of 185 g (males) 146 g females).
Fasting period before study: bred on the premises
Housing: caged singly
Diet: commercial pelleted diet (Oakes Special Diet with added V/it. E), ad libitum
Water: ad libitum

ENVIRONMENTAL CONDITIONS
Temperature: 21°C (+/- 2°)
Photoperiod (hrs dark / hrs light): 12/12 hours

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

A 25% W/V suspension of the compound in tap water was administered as a single dose by gavage to rats which had been, fasted for 18 hours,at a dose rate of 20 ml/kg (equivalent to 5 g/kg of compound).

No. of animals per sex per dose:

10 rats (5 male, 5 female)

Details on study design:

OBSERVATION
After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 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

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

Acute oral median lethal dose (LD50 ) in rats: > 5 g/kg body weight.

Executive summary:

A 25% W/V suspension of the compound in tap water was administered as a single dose by gavage to rats which had been, fasted for 18 hours,at a dose rate of 20 mL/kg (equivalent to 5 g/kg of compound). No guideline was reported and no GLP was followed.

After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period« surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.

The acute oral median lethal dose (LD50 ) in rats was stated greater than 5 g/kg body weight.