Reaction mass of sodium 3-[[4-[(4-ethoxy-m-tolyl)azo]-1-naphthyl]azo]benzenesulphonate and sodium 3-[[4-[(4-ethoxyphenyl)azo]-1-naphthyl]azo]benzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Remarks:

source of read across

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

Test item was administered, by oral gavage, to 5 male and 5 female rats at a single dose of 5000 mg/kg bw; substance was dissolved in water at room temperature and given at volume of 30 mg/kg bw. Animals were observed over a period of 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen.
- Age at study initiation: 9 - 14 weeks.
- Weight at study initiation: 173 g
- Housing: Makrolon cage type III, in groups of 5.
- Diet: Altromin R 1324, ad libitum.
- Water: tap water ad libitum.
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1.5 °C
- Relative humidity: 60 ± 5 °C
- Photoperiod: 12 hrs dark / 12 hrs light; artificial illumination from 7 a.m. to 7 p.m.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Substance was dissolved in water at room temperature and given at volume of 30 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice a day (once on weekends and holidays).

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

Clinical signs:

Test item resulted to be relatively non-toxic in the acute test.

Body weight:

Body weight resulted to be unaffected.

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

LD50 (males and females) > 5000 mg/kg bw

Executive summary:

Test item was administered, by oral gavage, to 5 male and 5 female rats aa a single dose of 5000 mg/kg bw; substance was dissolved in water at room temperature and given at volume of 30 mg/kg bw. Animals were observed over a period of 14 days.

Body weight resulted to be unaffected and the test item resulted to be relatively non-toxic. The LD50 value was indicated to be higher than 5000 mg/kg bw.

Conclusion

LD50 (males and females) > 5000 mg/kg bw