2-chloro-4-nitrotoluene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 84/449 EWG

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-chloro-4-nitrotoluene

EC Number:

204-501-7

EC Name:

2-chloro-4-nitrotoluene

Cas Number:

121-86-8

Molecular formula:

C7H6ClNO2

IUPAC Name:

2-chloro-1-methyl-4-nitrobenzene

Details on test material:

- Name of test material (as cited in study report): 2-Chlor-4-nitrotoluol rein krist.
- Purity: 99.4 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann (Borchen, Germany)
- Age at study initiation: approx. 10 wks (males) and approx. 14 wks (females)
- Mean weight at study initiation: 249 g (males) and 209 g (females)
- Housing: individually in polycarbonate cages on low dust wood granulate bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 10
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: polyethylene glycol 400

Details on dermal exposure:

TEST SITE
- % coverage: approx. 10
- Type of wrap if used: gauze patch fixed with an elastic adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with tepid water
- Time after start of exposure: approx. 24 hours

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of application as well as at least once daily during observation period (clinical signs, mortality); animals were weighed individually at application, after one week and at the end of the 14-day observation period.
- Necropsy of survivors performed: yes

Statistics:

none (limit test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All male and female animals survived the treatment.

Clinical signs:

other: Neither clinical signs nor local skin reactions were observed in both sexes.

Gross pathology:

The necropsies performed at the end of the study revealed no findings in male and female animals.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Executive summary:

The acute dermal toxicity of 2-Chlor-4-nitrotoluol rein krist. was low with an LD50 value > 2000 mg/kg bw for male and female rats according to guideline 84/449 EWG. The test dose 2000 mg/kg bw revealed no mortality. Neither clinical signs nor local skin reactions were observed in both sexes. There were no effect on body weight development in males. In females the body weight gain was decreased in the first week and 4/5 females showed an increase in body weight during the second week.