2,6-dimethylcyclohexylamine

Skin irritation / corrosion

Administrative data

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.

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:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

only 3 min and 1 h exposure

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,6-dimethylcyclohexylamine

EC Number:

229-942-2

EC Name:

2,6-dimethylcyclohexylamine

Cas Number:

6850-63-1

Molecular formula:

C8H17N

IUPAC Name:

2,6-dimethylcyclohexan-1-amine

Details on test material:

Stability: 2 years
no further data

Test animals

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

Test system

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

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Any other information on results incl. tables

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

   

 

Applicant's summary and conclusion

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).