Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed according to EPA OPP Guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Bis-4-aminocyclohexylmethane, no further details.
Physical state is a solid powder. Indicates trans-trans content of 48% or higher.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
- Age: no data
- Weight at study initiation: 2-3 kg

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: none, test substance applied as powder
Details on dermal exposure:
no data
Duration of exposure:
no data
Doses:
- Males: 200, 400, 1580, 6310 mg/kg
- Females: 200, 1580, 2240, 3160, 6310 mg/kg
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
ADMINISTRATION:
- Area covered: 10% of the body surface
- Occlusion: semi-occlusive, 24 hours contact time
- Removal of the test substance: with water or an appropriate solvent.

EXAMINATIONS:
- Mortality and clinical signs (twice daily on weekdays and once daily on weekends)
- body weight (day of dosing, after 1 week, and prior to sacrifice)
- necropsy (all animals).
Statistics:
Statistical method: Moving Average Method

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 110 mg/kg bw
Based on:
test mat.
Mortality:
- Males: 200, 400, 1580, 6310 mg/kg: 0/5, 0/5, 3/5, 5/5. All deaths within 4 days post-dose
- Females: 200, 1580, 2240, 3160, 6310 mg/kg: 0/5, 0/5, 3/5, 5/5, 5/5. All deaths within 4 days post-dose
Clinical signs:
Males:
- Mild erythema, oedema and/or signs of necrosis were noted after unwrapping at 24 hours.
- Throughout the observation period surviving males showed slight irritation (200 mg/kg) or necrosis (400, 1580, 6310 mg/kg). Incidental findings were dried faecal material, absence of faecal material, nasal discharge, lethargy and labored breathing.
Females:
- Mild erythema, oedema and/or signs of necrosis were noted after unwrapping at 24 hours.
- Throughout the observation period surviving females showed necrosis. Incidental findings were ataxia, tremors, lethargy, dehydration, cyanosis and labored breathing.
Body weight:
A decreased body weight gain was noted for the surviving females. Body weight gain for surviving males was considered to be normal.
Gross pathology:
Males:
- Hemorrhagic lungs, nasal discharge, injected stomach vessels at 1580-6310 mg/kg, pale mottled liver and pale kidneys were observed in several males at 6310 mg/kg.

Females:
- Hemorrhagic lungs and nasal discharge at 3160 mg/kg. Pale mottled liver and pale kidneys were observed at 3160 and 6310 mg/kg.

Any other information on results incl. tables

The test material used in this test may be different from the material used currently. The currently available substance is a colorless liquid, whereas this substance is described as a powder. The difference has been explained by different proportions of isomers.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50=2110 mg/kg bw