4-chloro-2-nitroaniline

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Test performed prior to the implementation of the current acknowledged testing and GLP guidelines . The test conduct however was in principle very similar to the OECD TG 401 as adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-chloro-2-nitroaniline

EC Number:

201-925-4

Cas Number:

89-63-4

Molecular formula:

C6H5ClN2O2

IUPAC Name:

4-chloro-2-nitroaniline

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Hoe WISKf (SPF71)
- Source: Hoechst AG, breeding colony
- Weight at study initiation: 174 to 184 g, average 180,4 g
- Fasting period before study: 16 hours
- Housing: plastic cage
- Diet: Altromin 1324, ad libitum
- Water. tap water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2 % starch mucilage

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 % suspension (w/v)

Doses:

5.000 mg/kg bw

No. of animals per sex per dose:

10 females

Control animals:

not specified

Details on study design:

No difference between the sexes were observed in preliminary experiments. Therefore female animals were selected for the main experiment.

- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

- 1 animal 24 h after application

Clinical signs:

other: - urine was stained orange, skin yellow. Passivity, prone possition, palpebr. fissure narrow. 1 day after application coat bristling and irregulate respirating in addition.

Gross pathology:

Yellow staining of fat tissue and gastrointestinal tract in the animal, that died after 24 h.
No findings in all other animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Single application of the limit dose of 5.000 mg test item per kg bw did cause 10 % lethality in female rats during the 14 days observation period, resulting in a LD50 > 5.000 mg/kg bw.

Executive summary:

Female rats were subjected to test acute oral toxicity. The test item was administered at the limit dose of 5.000 mg/kg bw to 10 female rats. During the 14 days observation period 1 animals died (24 h after application). Yellow stained fat tissue and gastrointestinal tract found in necropsy of this animal. There were no findings in all other animals

Thus leading to a LD50 > 5.000 mg/kg bw. Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.