Cyclohexyl(methyl)amine

Acute Toxicity: dermal

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: non GLP, but reported in detail and procedure comparable to OECD guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Body weight after 14 days not reported; less details on housing conditions and test item.

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Name of the test substance used in the study report: N-Monomethylcyclohexylamin
physical state: liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weights for male animals: 218 g, mean body weights for female animals: 180 g
A standardized animal laboratory diet as well as drinking water were available ad libitum.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test substance was applied in concentrations of 50% (400 mg/kg) and 100% (1000 mg/kg).
The product was applied to the clipped skin of the back and flank (area about 50 cm2) unchanged in a dose of 1000 mg/kg and as a 50% aqueous formulation in a dose of 400 mg/kg.
The hair was removed from the dorsal and lateral parts of the trunk using electric clippers about 15 to 24 hours before the application. Only animals with healthy and intact skin were used for the study.
The test substance or the formulation of the test substance was applied uniformly to an area of about 50 cm2. The treated area of skin was then covered with an inert foil, which was secured in position with adhesive tape. The bandage was removed after a 24-hour period of contact; subsequently the compound was washed off with warm water and dried with cellulose.

Duration of exposure:

24 h

Doses:

400, 1000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Examinations:
Mortality within 14 days
Signs of systemic toxicity and local changes
Necropsy of the animals that died intercurrently and of those sacrificed by carbon dioxide at the end of the observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 400 - < 1 000 mg/kg bw

Mortality:

400 mg/kg: no deaths after 14 days
1000 mg/kg: 5/6 after 14 days
(see table 1)

Clinical signs:

Signs af systemic toxicity: Dyspnea, apathy, excitatian, staggering, atony, trembling, poor general state.
Local changes: 24 hours after application severe soft necrosis, slight till severe edema; after 7 days severe parchmeng-like necrosis, partly sallied; after 13 days severe leather-like necrosis, partly sallied.

Gross pathology:

Animals that died: acute congestive hyperemia; heart: acute dilatation of the atrium; lung: slightly edematous, acute middle-graded pulmonary emphysema; liver: peripheral lobule delineation.
Sacrificed animals: nothing abnormal detected.

Any other information on results incl. tables

Table 1: Onset and incidence of mortality

			number of animals found dead
Dose	gender	total number in dose group	1h	24h	48h	7 days	14 days
1000 mg/kg bw	males	3	0	0	0	2	2
1000 mg/kg bw	female	3	0	1	3	3	3
400 mg/kg bw	males	3	0	0	0	0	0
400 mg/kg bw	females	3	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LC50 (rat, dermal) is between 400 and 1000 mg/kg bw.