2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 September 1978 - 16 November 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

two dose levels; scarce study report omitts details of test conditions which are, however, contained in raw data.

Principles of method if other than guideline:

BASF-Test

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)

EC Number:

229-962-1

EC Name:

2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)

Cas Number:

6864-37-5

Molecular formula:

C15H30N2

IUPAC Name:

4-[(4-amino-3-methylcyclohexyl)methyl]-2-methylcyclohexan-1-amine

Test animals

Species:

rabbit

Strain:

Vienna White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males: 2.95 kg; females: 3.1 kg
- Diet: SNIFF, ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm² (200 mg/kg bw) and 45 - 102 cm² (400 mg/kg bw)

REMOVAL OF TEST SUBSTANCE
- Washing: After the application time the skin was washed with water/Lutrol (1:1)
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

200, 400 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 400 mg/kg bw

Mortality:

400 mg/kg bw: After day 7 4/5 males and 5/5 female rabbits died and mortality ocurred mainly within the first 24 hours.
200 mg/kg bw: None of the 5 male rabbits died and 3/5 females died within 24 hours.

Clinical signs:

other: Systemic toxicity: cyanosis, apathy, dyspnea, accelerated breathing, abdominal position with flaccid extremities, lateral position, trembling. Local irritations: All animals showed formation of soft necrosis after removal of dressing. The surviving animal

Gross pathology:

Animals that died:
Heart: acutely dilated, right; acute congestion;
Lungs: notable congestion, in some animals edematized;
Liver: gray-white lobular periphery broader.

Any other information on results incl. tables

Table 1: Mortality

Dose (mg/kg bw)	Gender	1 h	24 h	48 h	7 days	14 days
200	male	0/5	0/5	0/5	0/5	0/5
200	female	0/5	3/5	3/5	3/5	3/5
400	male	0/5	3/5	3/5	4/5	4/5
400	female	0/5	5/5	5/5	5/5	5/5

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria