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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: Comparable to guideline study with acceptable restrictions (no data on purity of test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Principles of method if other than guideline:
Method: other: acc. to protocols of Publication 1138 of the Natl. Acad. of Science, Natl. Res. Council (1964)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): nitrobenzene, J. T. Baker
- Analytical purity: no data
- Lot: 24 752

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
ethanol
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped trunk
- Type of wrap if used: sleeves secured with extra layers


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Animals were rinsed with cold tap water and wiped dry.
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 7 - 10 ml in the solvent, depending on animal size
- Concentration (if solution): no data
Duration of exposure:
24 h
Doses:
560, 760 and 1000 mg/kg
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: no data
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs and determination of methemoglobin

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
ca. 760 mg/kg bw
Remarks on result:
other: estimated
Mortality:
At 560 mg/kg, no animal died. At 760 and 1000 mg/kg, 80% of the animals died. Death occured at 48 to 96 and 24 to 48 h after application, respectively.
Clinical signs:
560 mg/kg: lethargy, persisting discoloration of skin and eyes; 760 and 1000 mg/kg: lethargy, collapse, loss of coordination
Other findings:
Methemoglobinemia manifested in less than 20 minutes post application.

Any other information on results incl. tables

Dose [g/kg]

Mortality ratio

Observation time

Reactions

Screening

0.33

0/1

14 days

Discoloration, slight cyanosis, lethargy

1

0/1

14 days

Discoloration, cyanosis, lethargy

1.35

2/2

24 h

Death 24 h

1.8

1/1

24 h

Death 24 h

3.3

1/1

48 h

Comatose and death at 30 h

Test trials

0.56

0/5

14 days

Lethargy, persisting discoloration of skin and eyes

0.76

4/5

14 days

Lethargy, collapse, loss of coordination, death 48 – 96 h

1

4/5

14 days

Lethargy, collapse, loss of motor coordination, death 24 – 48 h

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information