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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific priciples, only female rats were used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Method: other: see freetext TC
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: 1,2-dichloro-4-nitrobenzene, no data on purity

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMAL
- Weight at study initiation: 167-193 g
- Housing: individually
- Diet . ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: sesame oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 30 cm²
- Type of wrap if used: alu fole

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological examination
Statistics:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
see section"remarks on results includieng tables and figures"
Clinical signs:
see section"remarks on results includieng tables and figures"
Body weight:
see section"remarks on results includieng tables and figures"
Gross pathology:
see section"remarks on results includieng tables and figures"

Any other information on results incl. tables

RS-Freetext:
Mortality: 0/6
The dermal application caused no irritation and the
macroscopic examination after 14 d gave no adverse effects.

Applicant's summary and conclusion

Executive summary:

Single dermal application of 1,2 -Dichloronitrobenzene to the shaved, intact back of 6 female rats caused no mortalit and no clinical findings. Thus the LD50 > 2000 mg/kg bw is determined (Hoechst AG 1975).