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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:
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:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
yes
Remarks:
; limit 1000 not 2000 mg/kg bw , no females tested, reporting deficiencies
GLP compliance:
no
Test type:
other: limit test
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3,4-Dichloroanilin rein
- Physical state: solid

Test animals

Species:
rat
Strain:
other: Wistar TNO W 74
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 14 weeks
- Weight at study initiation: 197 g
- Fasting period before study: no
- Housing: 5 animals per Macrolon type III cage
- Diet: ad libitum, Altromin 1324
- Water: ad libitum, tap water

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:
other: liquid not specified
Details on dermal exposure:
according to Noakes and Sanderson, 1969, Brit. J. Industr. Med. 26: 59-63
Duration of exposure:
4 or 24 h not specified
Doses:
1000 mg/kg bw
No. of animals per sex per dose:
10 male
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: repeated observation on day of application, twice a day thereafter
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight
Statistics:
no data

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Mortality:
no mortality observed
Clinical signs:
no signs of toxicity
Body weight:
no difference
Gross pathology:
not applicable

Applicant's summary and conclusion

Executive summary:

Löser, E., 1981

After acute dermal exposure of male Wistar rats to 1000 mg 3,4-dichloroaniline /kg bw no signs of toxicity were evident and no mortality was observed.