Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Principles of method if other than guideline:
Acute dermal toxicity in rats
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,3-Dichloronitrobenzene
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 179 g
- Housing: 5 animals per cage (Macrolon type III)
- Diet (e.g. ad libitum): Altromin R 1324 (Altromin GmbH, Lage, Germany) ad libitum
- Water (e.g. ad libitum): tap-water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
not specified
Vehicle:
polyethylene glycol
Duration of exposure:
not specified
Doses:
2500 mg/kg bw
No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs and mortality several times on the day of administration, and twice daily thereafter (once on weekends and holidays) up to the end of the observation period. Animals were weighed on the day of admisitration and at hte end of the 14-days observation period.
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
no effects
Clinical signs:
no effects
Body weight:
no effects
Gross pathology:
not examined

Any other information on results incl. tables

No signs of toxicity were observed in all male animals treated with 2500 mg/kg bw. No mortalities occurred.

Applicant's summary and conclusion