3-cyclohexylaminopropylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 1963

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

study review

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

sex not specified, test substance not removed after 24 h, no statistics, only 3 animals per dose group used, shorter observation period of 7 days

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-cyclohexylaminopropylamine

EC Number:

222-001-7

EC Name:

3-cyclohexylaminopropylamine

Cas Number:

3312-60-5

Molecular formula:

C9H20N2

IUPAC Name:

N1-cyclohexylpropane-1,3-diamine

Test material form:

liquid

Details on test material:

3-Cyclohexylaminopropylamine from Performance Chemicals, lot number: 68-219-BC

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

Rabbits weighting between 2.0 and 2.8 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

Three dose groups were used in the study. All rabbits were prepared for the test by closely clipping the fur over the trunk and each rabbit was given a single application of the test compound. The test material was spread evenly over the back by a glass rod, and the rabbit was then wrapped in gauze and covered by a further wrapping of rubber damming, fastened with adhesive tape. The rabbits were then returned to their cages where food and water were available.

Duration of exposure:

After single exposure of test material, the animals were observed for seven days.

Doses:

Group 1 2000 mg/kg 3 rabbits
Group 2 632 mg/kg 3 rabbits
Group 3 200 mg/kg 3 rabbits

No. of animals per sex per dose:

3 animals per dose

Control animals:

no

Details on study design:

Three dose groups. All rabbits were prepared for the test by closely clipping the fur over the trunk and each rabbit was given a single application of the test compound. The test material was spread evenly over the back by a glass rod, and the rabbit was then wrapped in gauze and covered by a further wrappingof rubber damming, fastened with adhesive tape.. The rabbits were then returned to their cages where food and water were available.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

not specified

Dose descriptor:

LD100

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 632 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All rabbits in the high dose group died within 28 hours after dosing

Clinical signs:

other: Considerably pain in the HD and MD dose group because the animals in these dose groups screamed for several minutes after application if test compound

Gross pathology:

Badly damaged skin and necrosis in the MD animals. In dead animals of the HD group: Black thickened skin and internally adhesions of cecum and portions of small intestine to the peritoneal lining of one rabbit receiving 632 mg/kg.

Any other information on results incl. tables

Acute Dermal toxicity for the Rabbit

Rabbit No	Dose in mg/kg	Body weight initial [kg]	Body weight sacrifice [kg]	Day 1	Day 2	Day 3	Day 4	Day 5	Day 6	Day 7	Autopsy
1	2000	2.3		dead							Compound has burned through all layers of skin and the entire intestinal tract appeared hemorrhagic
2	2000	2.0		XXX							Pupils dilatated, weak, depressed apperance
Erythema					dead
Edema
3	2000	1.9		dead							Compound has burned through skin
4	632	2.0	1.7								Pupils dilated
Erythema				XXX	XXX	XXX	XXX	Black, necrotic		sac
Edema				XXX	XXX	XXX	XXX
5	632	2.1	1.8								Pupils dilated
Erythema				XXX	XXX	XXX	XXX	Black, necrotic		sac
Edema				XXX	XXX	XXX	XXX
6	632	2.3	1.9								Pupils dilated
Erythema				XXX	XXX	XXX	XXX	necrotic		sac
Edema				XXX	XXX	XXX	XXX
7	200	2.4	2.2								Pupils slightly dilated
Erythema				XXX	XXX	XX	XX	necrotic		sac
Edema				XXX	XXX	XXX	XXX
8	200	2.3	2.1								Pupils slightly dilated
Erythema				XXX	XXX	XX	XX	necrotic		sac
Edema				XXX	XXX	XXX	XX
9	200	2.4	2.2								Pupils slightly dilated
Erythema				XXX	XXX	XX	XX	necrotic		sac
Edema				XXX	XXX	XXX	XX

Applicant's summary and conclusion

Conclusions:

The compound is considered to be a severe skin irritant and possesses the ability to penetrate the skin and produce systemic toxicity and even death in the rabbit.

Executive summary:

Nine albino rabbits were divided into three dose groups of 200, 632 and 2000 mg/kg. The test material was applied to the clipped skin once and then the rabbit was wrapped in gauze and covered by wrapping of rubber damming. All three rabbits of the high dose died within the first 28 h after dosing. All survivors lost 300 - 400 g in body weight. The skin wad badly damaged in all cases and showed severe necrosis. Post-mortem observations on survivors included: black, thickened skin and internally adhesions of cecum and portions of small intestine to the peritoneal lining of one rabbit in MD.

The compound must be considered as severe skin corrosive and possesses the ability to penetrate the skin and to produce systemic toxicity and the LD 50 value was determined to be between 632 and 2000 mg/kg bw/d.