Reaction mass of ethyl 2-ethyl-6,6-dimethylcyclohex-2-enecarboxylate and ethyl 2,3,6,6-tetramethylcyclohex-2-enecarboxylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 August to 25 August 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate

EC Number:

261-020-5

EC Name:

Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate

Cas Number:

57934-97-1

Molecular formula:

C13H22O2

IUPAC Name:

ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate

Constituent 2

Reference substance name:

Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate

EC Number:

278-776-7

EC Name:

Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate

Cas Number:

77851-07-1

Molecular formula:

C13H22O2

IUPAC Name:

ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate

Specific details on test material used for the study:

Test material (as stated in report): Givescone
Batch No.: 9000375280
Colourless to pale yellow liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Age at start of treatment 15 weeks (male) and 14 to 15 weeks for (females).
Body weighs at start of treatment 2.8 to 3.0 Kg
Accommodation: individually in stainless steel cages equipped with feed hoppers, drinking water bowls

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of Givescone undiluted

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours as well as 7 and 10 days after removal of the dressing, gauze patch and test item.

Number of animals:

1 male and 2 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 67

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

erythema score

Basis:

animal: 68

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal: 69

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal: 67

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

edema score

Basis:

animal: 68

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 6

Irritation parameter:

erythema score

Basis:

animal: 69

Time point:

24/48/72 h

Score:

0

Max. score:

0

Any other information on results incl. tables

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. Well defined erythema was observed in all animals at the 1 -hour reading and decreased in severity in one animal at 24 hours, in another at 48 hours and in the third animal 72 hours befoer disappearing at day 7 in all animals. Very slight oedema was noted in all animals at the 1 -hour reading and persisted in one animal through to 72 hours. Slight scaling was observed in all animals at 7 days.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Givescone is considered to be not irritating to rabbit skin in this test conditions and does not meet the GHS criteria for skin irritation classification.

Executive summary:

The primary skin irritation potential of GIVESCONE was investigated by topical semi occlusive application of 0.5 ml to 6 cm2 intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was paerformed 1, 24, 48 and 72 hours, as well as 7 and 10 days after removal of dressing. The scores of each animal at the following reading times (24, 48 and 72 hours) were used on calculating the respective mean values for each type of lesion.

Local signs (mean values from 24 to 72 hours) consisted of grade 1.33 erythema and grade 0.33 oedema.

Well defined erythema was observed in all animals at the 1 -hour reading and decreased in severity in one animal at 24 hours, in another at 48 hours and in the third animal 72 hours befoer disappearing at day 7 in all animals. Very slight oedema was noted in all animals at the 1 -hour reading and persisted in one animal through to 72 hours. Slight scaling was observed in all animals at 7 days.

The test item caused no staining of the treated skin. No corrosive effects were notes on the treated skin of any animal at any measuring interval.

Based upon the referred GHS classification criteria, Givescone is to be not irrittating to rabbit skin.