Dimethylcyclohex-3-ene-1-carbaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 June - 23 June 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study was not continued until the total disappearance of the effects.

Justification for type of information:

The information is used for read across to Vertoliff.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: read-across information from an analogue is used

Justification for type of information:

The skin irritation of Vertoliff is based on read-across from Triplal. The full read-across document can be found in the Irritation Endpoint Summary in text and in the attached file.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Remarks:

mean of all 4 animals from time points: 24, 48 and 72 hrs

Time point:

24/48/72 h

Score:

2

Max. score:

2.5

Reversibility:

not fully reversible within: 7 days

Remarks on result:

no indication of irritation

Remarks:

based on scoring

Irritation parameter:

edema score

Basis:

mean

Remarks:

mean of all 4 animals from time points: 24, 48 and 72 hrs

Time point:

24/48/72 h

Score:

1.2

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

no indication of irritation

Remarks:

based on scoring

Interpretation of results:

other: Skin irritant cat. 2

Remarks:

in accordance with EU CLP (EC No. 1272/2008 and its updates)

Conclusions:

Based on read across from Triplal, which is tested in a similar to OECD TG 404 study, Vertoliff is a skin irritant cat. 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dimethylcyclohex-3-ene-1-carbaldehyde

EC Number:

268-264-1

EC Name:

2,4-dimethylcyclohex-3-ene-1-carbaldehyde

Cas Number:

68039-49-6

Molecular formula:

C9H14O

IUPAC Name:

2,4-dimethylcyclohex-3-ene-1-carbaldehyde

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Healthy female rabbits were obtained from A. Smith Warlingham, Surrey. Animals were allowed an acclimatisation period of eighteen days. The rabbits were individually housed in grid bottomed metal cages. A commercially available antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diet Services, Witham, Essex) and mains drinking water via automatic nozzles in each cage were available ad libitum. The rabbit holding room was air-conditioned with temperature in the range of 18-22°C and relative humidity in the range of 48-66% during the acclimatisation and study periods. Fluorescent lighting was controlled to give an artificial cycle of 12 hours light / 12 hours dark per day.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 ml of the test material

Duration of treatment / exposure:

4 hours

Observation period:

7 days

Number of animals:

4

Details on study design:

The test material was applied on the back of animals. After removal of the adhesive tapes, the treated sites were cleansed by gentle swabbing with cotton wool soaked in warm water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

mean of all 4 animals from time points: 24, 48 and 72 hrs

Time point:

24/48/72 h

Score:

2

Max. score:

2.5

Reversibility:

not fully reversible within: 7 days

Remarks on result:

no indication of irritation

Remarks:

based on scoring

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

mean of all 4 animals from time points: 24, 48 and 72 hrs

Time point:

24/48/72 h

Score:

1.2

Max. score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

no indication of irritation

Remarks:

based on scoring

Any other information on results incl. tables

	Erythema	Oedema
1 hour
Rabbit 1	2	0
Rabbit 2	1	2
Rabbit 3	2	2
Rabbit 4	2	2
24 hours
Rabbit 1	2	1
Rabbit 2	2	1
Rabbit 3	2	1.5
Rabbit 4	2	2
48 hours
Rabbit 1	2	1
Rabbit 2	2	1.5
Rabbit 3	2	1
Rabbit 4	2	1.5
72 hours
Rabbit 1	2	0.5
Rabbit 2	2.5	1
Rabbit 3	2	1
Rabbit 4	2	1
7 days
Rabbit 1	1	0
Rabbit 2	1.5	0.5
Rabbit 3	1.5	0.5
Rabbit 4	2	0.5

Applicant's summary and conclusion

Interpretation of results:

other: Skin irritant Cat. 2

Remarks:

in accordance with EU CLP (EC No. 1272/2008 and its updates)

Conclusions:

Under the conditions of this study performed with rabbits similar to OECD 404, the scores obtained in test animals were not sufficient for classification. However, the effects did not disappear until the last taken observation (at day 7) and observations were not taken further, therefore there is no certainty that the effects would disappear completely. As a conservative approach, Triplal is classified as a skin irritant (category 2).

Executive summary:

The skin irritation potential of Triplal was tested in vivo using 4 New Zealand White rabbits. Study was performed similar to OECD 404 with an observation period shorter than needed and therefore a Klimisch 2 rating was assigned. The test material was applied on the skin under a surgical patch, which was covered with elastic adhesive bandage. After an exposure period of 4 hours the patches were removed. The animals were observed at 24, 48 and 72 hours after patch removal and also later, until 7 days. The dermal effects observed at 24 hours after patch removal encompassed moderate erythema (all animals scored 2) and slight to moderate oedema (1 animal scored 2, 1 animal scored 1.5 and 2 animals scored 1). The dermal effects observed at 48 hours stayed at the same moderate erythema (all animals scored 2) and slight to moderate oedema (2 animals scored 1.5 and 2 animals scored 1). At 72 hours, oedema effects decreased (3 animals scored 1 and 1 animal scored 0.5), the erythema effects stayed at the same level (1 animal scored 2.5 and 3 animals scored 2). The last observation was made at 7 days and then there were still signs of both erythema (1 animal scored 2, 2 animals scored 1.5 and 1 animal scored 1) and oedema (3 animals scored 0.5 and 1 animal scored 0). Although the scores obtained in test animals at the time points 24/48/72 hrs were not sufficient for classification, the study was not continued until the complete disappearance of the effects (and the scores for erythema were still moderate). As a conservative approach, Triplal is classified as a skin irritant (category 2).