4,4'-azobis[4-cyanovaleric] acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 February 1999 - 16 June 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

yes

Remarks:

no deviations that were considered to have affected the integrity or validity of the study

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

1996

Deviations:

yes

Remarks:

no deviations that were considered to have affected the integrity or validity of the study

GLP compliance:

yes

Remarks:

expiry date of the test item is not indicated

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-azobis[4-cyanovaleric] acid

EC Number:

220-135-0

EC Name:

4,4'-azobis[4-cyanovaleric] acid

Cas Number:

2638-94-0

Molecular formula:

C12H16N4O4

IUPAC Name:

4,4'-azobis[4-cyanovaleric] acid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature in the dark and at 4 °C in the dark

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan U.K. Ltd., Bicester, Oxon, England
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 105 - 137 g
- Fasting period before study: yes
- Housing: 3 rats (same sex) / cage
- Diet: standard laboratory rodent diet, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: minimum 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 27 -52
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 or 20%
- Amount of vehicle: 10 mL/kg bw

Doses:

200 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations; twice daily; Weighing: On Days 1 (prior to dosing), 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths in groups of six rats (three males and three females) following an oral administration of the test substance at dosages of 200 and 2000 mg/kg bodyweight.

Clinical signs:

other: Piloerection was observed in all rats within four minutes of dosing. This sign persisted and was accompanied in rats later on Day 1 and/or at later intervals during the study by; hunched posture notable in all rats treated at 200 or 2000 mg/kg, with waddl

Gross pathology:

No abnormalities were revealed at the macroscopic examination at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met