Hydrogen [4-[[4-(diethylamino)-o-tolyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

June 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

The test was conducted by means of Read Across approach. Further information was attached at section 13

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)

Principles of method if other than guideline:

A single dose was administered to rats by oral gavage.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Acid Blue 015 - Similar Substance 01

IUPAC Name:

Acid Blue 015 - Similar Substance 01

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals:
Healthy Sprague-Dawley derived rats, bred on the premises, aged 5 - 6 weeks, having an average body weight of 167 g. (Males) and 125 g (Females).

Husbandry:
Rats were caged singly and kept in a room maintained at a temperature of 21 °C. (+/-2°). Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hour period. A commercial pelleted diet (Oakes Special Diet with added Vit. E) was fed ad lib. Hater was available at all times.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

Administration of Compound:
A 25 % w/v suspension of the compound in a 2 % aqueous solution of Carboxymethyl Cellulose was administered as a single dose by gavage to rats which had been fasted for 10 hours, at a dose rate of 20ml/kg. (Equivalent to 5g/kg compound).

Doses:

20 ml/kg (Equivalent to 5g/kg compound).

No. of animals per sex per dose:

Ten rats (5 males and 5 females).

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, organ examinations.

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No deaths occurred during the 14-day observation period.

Clinical signs:

No clinical symptoms were recorded during the 14 days observation period.

Body weight:

Not measured

Gross pathology:

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

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 > 5000 mg/kg body weight.

Executive summary:

The test article was administered as a single dose by oral gavage to rats of both sexes, at a dose of 5000 mg/kg in a solution of Carboxymethyl Cellulose. No clinical symptoms were recorded and no deaths occurred during the 14 day observation period.

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

The following death rate was observed:

0 % at 5000 mg/kg

The acute oral toxicity (LD50) of the test substance in rats of both sexes, observed over a period of 14 days, was estimated to be > 5000 mg/kg.