3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]

Endpoint summary

Description of key information

LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 12, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf, Switzerland.
- Age at study initiation: approximately 8 weeks.
- Weight at study initiation: males: 184 - 216 grams; females: 150 - 173 grams.
- Fasting period before study: overnight fasting.
- Housing: group housing of 5 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands).
- Diet: standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle Ag, Kaiseraugst, Switzerland) ad libitum.
- Water: ad libitum.
- Acclimation period: at least one week under laboratory conditions after physical examination. Only animals without any visual signs of illness were used for the study.
- Randomisation: randomly selected at time of delivery in groups of five.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55%
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): lighting was 12 hours artificial fluorescent light and 12 hours dark per day.

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 15 days.
- Mortality/Viability: at least three times each day.
- Body Weights: test days 1 (pre-administration), 8 and 15.
- Clinical Signs: each animal was examined for changes to treatment with particular attention paid to changes in behaviour, respiration, motility, body posture, motor susceptibility, skin, eyes, nose and fur. Observations were performed four times during day 1, and once daily during days 2 - 15. All abnormalities were recorded.
- Necropsy: necropsies were performed by experienced prosectors. All animals were necropsied. All animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide asphyxiation.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period

Clinical signs:

other: no clinical signs of ill health or behavioural changes were observed during the study period

Gross pathology:

Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

Method:

The test substance was tested for its Acute Oral Toxicity according to OECD guideline 401.

 

Observations:

No mortality occurred, no clinical signs were observed and no macroscopic abnormalities were seen at necropsy. 

 

Results:

LD50 > 2000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The test substance was tested for its Acute Oral Toxicity according to OECD guideline 401, at a limit dose of 2000 mg/kg bw. No mortality occurred, no clinical signs were observed and no macroscopic abnormalities were seen at necropsy. Therefore the LD50 calculated in this test was > 2000 mg/kg bw.

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).

 

In the case of oral exposure route, the acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories are:

- Category 1: ATE ≤ 5 mg/kg bw

- Category 2: 5 < ATE ≤ 50 mg/kg bw

- Category 3: 50 < ATE ≤ 300 mg/kg bw

- Category 4: 300 < ATE ≤ 2000 mg/kg bw

 

The oral LD50 value was established to be more than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity Category 4: 300 < ATE ≤ 2000 mg/kg bw).