3-[[2-(acetyloxy)ethyl][4-[(4-nitrophenyl)azo]phenyl]amino]propiononitrile

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:

From April 30 to May 15, 1985

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:

1985

Report date:

1985

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:

Male and female rats were administered the test substance at 5000 mg/kg bw by oral gavage. The application was followed by a 14-d observation period and thereafter the animals were sacrificed.

GLP compliance:

not specified

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 material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Breeder: Winkelmann, Borchen
Age: ca. 8 weeks old
Body weight: 153 -157 g
Temperature and relative humidity: 22 ± 1.5 °C and 60 ± 5 %, respectively
Light period: 12 h light - 12 h dark
Feed: Altromin R 1324

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

water

Details on oral exposure:

The test substance was diluted into water and administered at a constant rate by gavage. Animals did not have access to feed and water from 16 h before to 4 h after application.

Doses:

20 ml/kg (5000 mg/kg bw)

No. of animals per sex per dose:

5

Details on study design:

This was followed by a 14-d observation period. At the end of the study, animals were sacrified and an anatomo-pathological examination was done.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the study period.

Clinical signs:

No clinical symptoms were observed.

Gross pathology:

After the anatomo-pathological examination, no signs of toxicity were detected.

Applicant's summary and conclusion

Interpretation of results:

other: not classified within the CLP Regulation (EC 1272/2008)

Conclusions:

No mortality occurred at the dose of 5000 mg/kg, thus no LD50 could be determined.

Executive summary:

Method

Acute oral toxicity was assessed as limit test in rats; no guideline was specified. Male and female rats were dosed with test substance at concentration of 5000 mg/kg bw by oral gavage. The application was followed by a 14 -d observation period. At the end of the study, animals were sacrificed and a gross pathological examination was conducted.

Results

No deaths, no clinical symptoms during the observation period and no signs of toxicity at necropsy were recorded. Therefore, LD0 = 5000 mg/kg bw, LD50 > 5000 mg/kg bw.