3-cyclohexylaminopropylamine

Endpoint summary

Description of key information

There is no skin irritation/corrosion study available and therefore a data waiver is claimed. However, results of an acute dermal toxicity study (Abbott Labs, 1963) are available which indicate that

the compound N-Cyclohexyl-1,3-propanediamine must be considered as severe skin corrosive (Cat. 1). N-Cyclohexyl-1,3-propanediamine 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.

No study regarding eye irritation is available and a data waiver is claimed. The study does not need to be conducted because N-Cyclohexyl-1,3-propanediamine is classified as skin corrosive Cat. 1.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

poor documentation

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Species:

rabbit

Strain:

other: Albino

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml of test compound

Duration of treatment / exposure:

One application

Observation period (in vivo):

24 h

Number of animals or in vitro replicates:

6 albino rabbits

Details on study design:

Six adult albino rabbits were each treated by instilling into one eye 0.1 ml of the test compound. The opposite eye served as controlin each case and treatment was alternated, right to left, among the animals.
Eye damage was evaluated by the scoring system of Draize as described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics pp.51 (published by the association of Food and Drug Officials of the United States). Observations were made at 2 to 4 and at 24 hours, when these animals were sacrified.

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

mean of all animals

Time point:

other: 2-4- hours

Score:

80

Max. score:

80

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

Animal 1 and 2

Time point:

other: 2-4 hours

Score:

12

Max. score:

20

Reversibility:

not specified

Remarks on result:

probability of severe irritation

Irritant / corrosive response data:

All six rabbits screamed in pain upon instillation of the test compound. By two hours it was apparent that the eyes were permanently damaged, with the adjacent membranes and tissues severely burned. At 24 hours it was decided to sacrifice these rabbits since all were obviously permanently blinded and in great pain.

Rabbit Eye Irritation test Results

			Cornea			Iris		Conjunctivae
Rabbit No	Body weight initial [kg]	Observation time	Opacity	Area of involvement	Score	Iritis	Score	Erythema	Edema	Discharge	Score	Total score	Autopsy
1	2.4	2 - 4 h	4	4	80			3	2	1	12	92	Lids blackened, Permanent damage
		24h
		48h
		72h
		5 days
		7 days
2	2.3	2 - 4 h	4	4	80			3	2	1	12	92	Lids blackened, permanent damage
		24h
		48h
		72h
		5 days
		7 days
3	2.1	2 - 4 h	4	4	80			3				80	Permanent damage
		24h
		48h
		72h
		5 days
		7 days
4	2.3	2 - 4 h	4	4	80			3				80	Permanent damage
		24h
		48h
		72h
		5 days
		7 days
5	2.4	2 - 4 h	4	4	80			3				80	Permanent damage
		24h
		48h
		72h
		5 days
		7 days
6	2.3	2 - 4 h	4	4	80			3				80	Permanent damage
		24h
		48h
		72h
		5 days
		7 days

Conclusions:

The test compound must be considered to be a very severe eye corrosive substance, and small amounts in the eye may cause permanent blindness.

Executive summary:

Six adult albino rabbits were each treated by instilling into one eye 0.1 ml of the test compound. The opposite eye served as control in each case and treatment was alternated, right to left, among the animals.

Eye damage was evaluated by the scoring system of Draize. All six rabbits screamed in pain upon instillation of the test compound. By two hours it was apparent that the eyes were permanently damaged, with the adjacent membranes and tissues severely burned. At 24 hours it was decided to sacrifice these rabbits since all were obviously permanently blinded and in great pain. The test compound must be considered a very severe eye irritant, and small amounts in the eye may cause permanent blindness.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the assessment of two available animal studies (acute dermal toxicity and eye irritation) and according to criteria of CLP regulation 1272/2008 the substance N-Cyclohexyl-1,3-propanediamine is considered to causes severe skin burns and eye damage and was classified as Skin Corrosive Cat. 1.