2,6-dimethylcyclohexylamine

Endpoint summary

Description of key information

Corrosive to the skin. As the substance is corrosive to the skin it is concluded the the substance is also corrosive to the eye.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; exposure period only 1 h but necrosis was obvious; occlusive coverage conditions). The study is sufficient for evaluation.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

only 3 min and 1 h exposure

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Age at study initiation: no data
- Weight at study initiation: 2.92-3.73 kg
- Housing: single
- certified diet (ad libitum)
- tap water (ad libitum):
- Acclimation period: 8 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animals

Amount / concentration applied:

The test patch (2 .5 x 2 .5 cm) loaded with the test substance and applied to the dorsal skin; amount: ca. 0.5 ml

Duration of treatment / exposure:

1) 3 minutes
2) 1 hour

Observation period:

30-60 minutes after removal of the test patch and 24, 48, and 72 h after initiation of exposure

Number of animals:

1) n=6
2) n=3

Details on study design:

Washing of test site after removal of test patch with Lutrol or water/Lutrol.
Scoring according to Draize 1959 (comparable with OECD 404)
Histopathological verification of readings

Irritation parameter:

erythema score

Remarks:

(exposure duration 3 minutes)

Basis:

mean

Remarks:

of 6 rabbits

Time point:

24/48/72 h

Score:

3.72

Max. score:

4

Reversibility:

no data

Remarks on result:

other: necrosis of skin in all 6 rabbits; more pronounced effects after 24 h exposure

Irritation parameter:

edema score

Remarks:

(exposure duration 3 minutes)

Basis:

mean

Remarks:

of 6 rabbits

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Irritation parameter:

erythema score

Remarks:

/ (expsure duration 1 hour

Basis:

mean

Remarks:

/ of 3 rabbits

Time point:

24/48/72 h

Score:

4

Max. score:

4

Remarks on result:

other: necrosis of skin in all 6 rabbits; more pronounced effects after 1 h exposure

Irritation parameter:

edema score

Remarks:

/ (exposure duration 1 hour

Basis:

mean

Remarks:

/ of 3 rabbits

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Irritant / corrosive response data:

1) exposure duration 3 minutes
necrosis detected in 4/6 rabbits 24 h after exposure; oedema max. score 2
1) exposure duration 1 h
Necrosis in all 3 rabbits found 30-60 min after exposure period

Necrosis in all animals verified in macroscopic pathology.

Other effects:

no data

Skin irritation in rabbits after an exposure duration of 3 minutes or 1 hour

Scorring	Erythema mean score	Edema mean score	Necrosis detected
Exposure duration 3 minutes
1rabbit	3	2	No
2rabbit	3	2	No
3rabbit	3	2	No
4rabbit	3	2	No
5rabbit	2	1	No
6rabbit	3	2	No
24 h after initiation
1rabbit	4	2	Yes
2rabbit	4	2	Yes
3rabbit	3	2	No
4rabbit	4	2	Yes
5rabbit	2	1	No
6rabbit	4	2	Yes
48 h after initiation
1rabbit	4	2	Yes
2rabbit	4	2	Yes
3rabbit	4	2	Yes
4rabbit	4	1	Yes
5rabbit	2	2	No
6rabbit	4	2	Yes
72 h after initiation
1rabbit	4	1	Yes
2rabbit	4	1	Yes
3rabbit	4	1	Yes
4rabbit	4	1	Yes
5rabbit	4	2	Yes
6rabbit	4	2	Yes

 

Scorring	Erythema mean score	Edema mean score	Necrosis detected
Exposure duration 1 hour
1rabbit	4	2	Yes
2rabbit	4	2	Yes
3rabbit	4	2	Yes
24 h after initiation
1rabbit	4	2	Yes
2rabbit	4	2	Yes
3rabbit	4	2	Yes
48 h after initiation
1rabbit	4	2	Yes
2rabbit	4	2	Yes
3rabbit	4	2	Yes
72 h after initiation
1rabbit	4	1	Yes
2rabbit	4	1	Yes
3rabbit	4	1	Yes

   

 

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

In skin irritation studies in rabbits the undiluted test substance resulted in corrosive effects.

Executive summary:

The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; occlusive coverage conditions). The study is sufficient for evaluation.

Six rabbits received dermal application of 0.5 ml undiluted test substance under occlusive dressing in two experiments; the exposure time was 3 minutes and 1 h in the first experiment and 3 minutes only in the second experiment (followed by washing each). Scorring of skin irritation according to Draize was performed up to 60 minutes and 24, 48, and 72 h after removal of the patch.

In the 1st experiment (3 minutes and 1 h exposure) erythema score of 4 and necrosis of the skin was obvious within 1h after exposure (1h treatment) and 24 h after exposure (3 minutes and 1 h treatment) and in the 2nd experiment (3 minutes expousre) again after the 24 h reading.

Conclusion: In skin irritation studies in rabbits the undiluted test substance resulted in corrosive effects even after a short exposure period of 3 minutes (24 h post-exposure).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. details about the test substance; occlusive coverage conditions). The study is sufficient for evaluation.

Six rabbits received dermal application of 0.5 ml undiluted test substance under occlusive dressing in two experiments; the exposure time was 3 minutes and 1 h in the first experiment and 3 minutes only in the second experiment (followed by washing each). Scorring of skin irritation according to Draize was performed up to 60 minutes and 24, 48, and 72 h after removal of the patch.

In the 1st experiment (3 minutes and 1 h exposure) erythema score of 4 and necrosis of the skin was obvious within 1h after exposure (1h treatment) and 24 h after exposure (3 minutes and 1 h treatment) and in the 2nd experiment (3 minutes expousre) again after the 24 h reading.

Conclusion: In skin irritation studies in rabbits the undiluted test substance resulted in corrosive effects even after a short exposure period of 3 minutes (24 h post-exposure).

Eye irritation:

As the substance is corrosive to the skin and further more the results of the acute inhalation test reported in section 7.2.2 suggested lesions of the cornea by saturated vapour at 20°C. There is no need for further testing of eye irritation.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for skin irritation cat.1A and eye irritation cat.1 under Regulation (EC) No. 1272/2008.