N-cyclohexyl-N-methylcyclohexylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15/11/82 to 20/12/82

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: unspecified guideline

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-cyclohexyl-N-methylcyclohexylamine

EC Number:

231-453-4

EC Name:

N-cyclohexyl-N-methylcyclohexylamine

Cas Number:

7560-83-0

Molecular formula:

C13H25N

IUPAC Name:

N-cyclohexyl-N-methylcyclohexanamine

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL - ABBOTT-32512 (POLYCAT 12)
- Source and lot/batch No.of test material: lot No. 1104-232
- Expiration date of the lot/batch: not specified

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no, there is indicated direct calculation from ml of liquid (Polycat 12) to mg by specific gravity

OTHER SPECIFICS:
liquid; specific gravity 0.9235 mg/L

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

Details on test animals or conditions are not specified in incomplete copy of study report - there is available only a record sheet with identification data of study and final results plus copy of tables.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not available - incomplete copy of study report
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): exces test material were removed (from comment under table for local effects - detailed specification is not available)
- Time after start of exposure: on day 1

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): intact skin 0.3, 0,35, 0.41 ml/kg; abraded skin 0.22, 0,30, 0.41 ml/kg

Duration of exposure:

24 h

Doses:

intact skin 0.3, 0.35, 0.41 ml/kg; abraded skin 0.22, 0,30, 0.41 ml/kg
resp.
intact skin 277, 323, 379 mg/kg; abraded skin 203, 277, 379 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: day 0 exposure + 13 days of observation
- Frequency of observations and weighing: local effect observed on day 1, 3, 6, 9, 13; table for weighing is not available, probably not examined
- Necropsy of survivors performed: yes
All rabbits that died and up to three survivors per group were necropsied.
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Remarks:

intact skin

Effect level:

323 mg/kg bw

Based on:

test mat.

95% CL:

> 0.28 - < 0.43

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Remarks:

abraded skin

Effect level:

295 mg/kg bw

Based on:

test mat.

95% CL:

> 0.26 - < 0.41

Mortality:

see table below

Clinical signs:

other: see table below Comments: Most adverse effects were observed within an hour after treatment and lasted several hours. The onset of paralysis occurred between several hours and two days after treatment. Paralysis affected only the hindlimbs in some rabbits

Gross pathology:

yes; see attached picture Incidence of Gross Observations

Any other information on results incl. tables

Acute dermal toxicity of ABBOTT-32512 (POLYCAT12) in male rabbits

Systemic Effects

Dose level ml/kg	Dose level mg/kg	Mortality ratio (a)	Observations - Intact Skin
0.30	277	1/6	Increased activity, ataxia, jerks, tremors, dyspnea, convulsions, vocalization, paralysis, squinting(b) and cyanosis(b)
0.35	323	3/6	Paralysis, decreased activity (b), ataxia(b), tremors(b), dyspnea(b) and convulsions(b)
0.41	379	5/6	Decreased activity, ataxia, jerks, tremors, dyspnea, convulsions, vocalization, paralysis(b), squinting (b) and cyanosis (b)

Dose level ml/kg	Dose level mg/kg	Mortality ratio (a)	Observations - Abraded Skin
0.22	203	0/6	Paralysis(b)
0.30	277	3/6	Decreased activity, ataxia, jerks, tremors, dyspnea, convulsions, vocalization, paralysis(b) and cyanosis (b)
0.41	379	5/6	Decreased activity, ataxia, jerks, tremors, dyspnea, convulsions, vocalization, squinting, cyanosis and paralysis(b)

(a) number of rabbits that died/number of rabbits treated

(b) observed in only one or two rabbits

Acute dermal toxicity of ABBOTT-32512 (POLYCAT12) in male rabbits

Local Effects

local reaction	Dosage [ml/kg]	Average score - Intact skin
Day (a)		1	3	6	9	13
Erythema	0.30	3	3	3	2	2
	0.35	3	3	3	3	3
	0.41	4	3	3	3	3
Corrosion	0.30	1	1	1	2	2
	0.35	1	2	2	2	2
	0.41	2	1	1	1	1
Swelling	0.30	1	0	0	0	0
	0.35	2	0	0	0	0
	0.41	2	0	0	0	0

local reaction	Dosage [ml/kg]	Average score - Abraded skin
Day (a)		1	3	6	9	13
Erythema	0.22	3	3	3	3	3
	0.30	3	3	2	2	2
	0.41	4	3	3	3	2
Corrosion	0.22	2	2	2	2	2
	0.30	1	1	2	2	2
	0.41	1	1	1	1	1
Swelling	0.22	1	0	0	0	0
	0.30	2	0	0	0	0
	0.41	2	0	0	0	0

(a) The test material and an occlusive wrapping were applied on day 0. The wrapping and excess test material was removed on day 1.

 

0 = None

1 = Very slight

2 = Slight

3 = Moderate

4 = Severe

Applicant's summary and conclusion

Interpretation of results:

other: The substance has been classified according to the scale in box Overall remarks as very toxic.