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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
Nitrobenzene
EC Number:
202-716-0
EC Name:
Nitrobenzene
Cas Number:
98-95-3
Molecular formula:
C6H5NO2
IUPAC Name:
nitrobenzene
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 or test system 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:
other: 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