Cyclohex-1,2-ylenediamine

Endpoint summary

Description of key information

The substance showed corrosive effects when applied to the skin of rabbits. When applied to eyes of rabbits, the substance caused irreversible damage.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study (short-term test)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1981

Deviations:

yes

Remarks:

short exposure periods (3 m/ 1 h)

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: 3.04 - 3.48 kg
- Housing: individually in cages of stainless steel with wire mesh walk floors, 40*51 cm
- Diet (e.g. ad libitum): Kliba 341, 4 mm, Klingenthalmuehle AG, Kaiseraugst, CH; ca. 130 g/d
- Water (e.g. ad libitum): tap water, ca 250 mL/d
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS in fully air-conditioned rooms
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL

Duration of treatment / exposure:

3 min, 1 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5*2.5 cm on the upper third of the back or flanks

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)

SCORING SYSTEM: OECD Draize scoring system

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 min exposure

Time point:

other: 24 - 48 - 72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: full thickness necrosis in all animals; see table for details

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 min exposure

Time point:

other: 24 - 48 - 72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Irritation parameter:

erythema score

Basis:

mean

Remarks:

1 h exposure

Time point:

other: 24 - 48 - 72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: full thickness necrosis in all animals

Irritation parameter:

edema score

Basis:

mean

Remarks:

1 h exposure

Time point:

other: 24 - 48 -72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Exposition:	3 min
Animal	Reading *	Erythema	Edema	Symptoms
1	3 m	4	2	necrosis
2	3 m	4	2	necrosis
3	3 m	4	2	necrosis
1	24 h	4	2	necrosis
2	24 h	4	2	necrosis
3	24 h	4	1	necrosis
1	48 h	4	1	necrosis
2	48 h	4	1	necrosis
3	48 h	4	0	necrosis
1	72 h	4	1	full thickness necrosis, confirmed by grosspathology
2	72 h	4	1	full thickness necrosis, confirmed by grosspathology
3	72 h	4	0	full thickness necrosis, confirmed by grosspathology
mean animal 1	24 - 72 h	4.00	1.33
mean animal 2	24 - 72 h	4.00	1.33
mean animal 3	24 - 72 h	4.00	0.33
mean	24 - 72 h	4.00	1.00

Exposition:	1 h
Animal	Reading *	Erythema	Edema	Symptoms
1	1 h	4	2	necrosis
2	1 h	4	2	necrosis
3	1 h	4	2	necrosis
1	24 h	4	2	necrosis
2	24 h	4	3	necrosis
3	24 h	4	2	necrosis
1	48 h	4	2	necrosis
2	48 h	4	2	necrosis
3	48 h	4	1	necrosis
1	72 h	4	1	full thickness necrosis, confirmed by grosspathology
2	72 h	4	1	full thickness necrosis, confirmed by grosspathology
3	72 h	4	1	full thickness necrosis, confirmed by grosspathology
mean animal 1	24 - 72 h	4.00	1.67
mean animal 2	24 - 72 h	4.00	2.00
mean animal 3	24 - 72 h	4.00	1.33
mean	24 - 72 h	4.00	1.67

* time after start of exposure

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

Under the applied test conditions the test substance induced skin corrosion in all animals.

Executive summary:

A skin irritation/corrosion test was performed according to OECD 404 with six rabbits. The animals were exposed to 0.5 ml of test substance on the clipped skin under semiocclusive conditions for 3 minutes or 1 h. The skin reactions were observed for 72 h after the initial exposure. All six animals showed severe skin corrosion.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

other: Fed. Reg. 38 No .187 § 1500.42; adopted 1973

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: own breed of the test laboratory
- Weight at study initiation: 2.3 - 2.8 kg
- Diet (e.g. ad libitum): ALTROMIN 2023, Altromin GmbH, Lage, D

ENVIRONMENTAL CONDITIONS
not reported

Vehicle:

other: olive oil

Controls:

other: the untreated eyes served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Treatment was once

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
no

SCORING SYSTEM: OECD Draize scoring system

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

within 72 h

Remarks on result:

other: Effects already observed 1 h after treatment

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks:

within 72 h

Remarks on result:

other: Probable values; effects already observed 1 h after treatment

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks:

within 72 h

Remarks on result:

other: Effects already observed 1 h after treatment

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

within 72 h

Remarks on result:

other: Effects already observed 1 h after treatment

Other effects:

Strong discharge (score 3) was observed in all readings.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the conditions of the test the test substance is corrosive to the rabbit eye.

Executive summary:

An eye irritation/corrosion test was performed with six rabbits according to a FDA guideline. The animals were exposed to 0.1 ml of test substance. Strong corrosive effects were observed in all animals.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation 

Four skin irritation/corrosion tests were conducted each one using between three and eight rabbits and having DCH as test material. The animals were exposed to 0.5 or 1 ml or 500 mg of test substance on the clipped skin for up to 24 h (1 min, 3 min, 5 min, 15 min, 4 h, 20 h, under semi-occlusive or occlusive conditions). The skin reactions were observed for up to 28 days after the initial exposure. All of the tested animals showed skin corrosion.

 

Eye irritation

 

Eye irritation/corrosion tests for DCH were performed with either two or six rabbits. The studies were performed according to OECD 405 or a FDA guideline. The animals were exposed to 50 µl or 0.1 ml of DCH. In both studies it was concluded that the test substance was highly corrosive to the eyes of the animals.

Justification for classification or non-classification

According to the results of available data for the substance as well as the knowledge about its alkaline nature, the substance meets the criteria for classification as skin corrosive substance according to the criteria of Regulation (EC) No. 1272/2008 (CLP). Using the most conservative results reported the substances has to be classified in subcategory 1A (CLP).

According to the results of available data the test item meets the criteria for classification as causing irreversible damage to the eyes (Cat. 1) according to the criteria of Regulation (EC) No. 1272/2008 (CLP).