2-(1-(3',3'-dimethyl-1'-cyclohexyl)ethoxy)-2-methyl propyl propanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1994-04-26 to 1994-04-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to OECD test guideline No. 404 and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

yes

Remarks:

no data on the age of animals at study initiation

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

no data on the age of animals at study initiation

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Compliance Program (Inspection date: 1992-10-27)

Test material

Test material information

Constituent 1

Reference substance name:

2-{(1RS)-1-[(1SR)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE

Molecular formula:

C17 H32 O3

IUPAC Name:

2-{(1RS)-1-[(1SR)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE

Constituent 2

Reference substance name:

2-{(1RS)-1-[(1RS)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE

Molecular formula:

C17 H32 O3

IUPAC Name:

2-{(1RS)-1-[(1RS)-3,3-DIMETHYLCYCLOHEXYL]ETHOXY}-2-METHYLPROPYL PROPIONATE

Constituent 3

Reference substance name:

2-METHYL-2-{[(1RS,2RS)-2,6,6-TRIMETHYLCYCLOHEPTYL]OXY}PROPYL PROPIONATE

Molecular formula:

C17H32O3

IUPAC Name:

2-METHYL-2-{[(1RS,2RS)-2,6,6-TRIMETHYLCYCLOHEPTYL]OXY}PROPYL PROPIONATE

Test material form:

liquid

Details on test material:

- Physical state: clear colourless liquid
- Storage condition of test material: in the dark at approximately 4°C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield Farms (UK) Limited, Froxfield, Hamshire.
- Age at study initiation: no data
- Weight at study initiation: 3.5, 3.7 and 3.9 kg
- Housing: individually in grid bottomed metal cages.
- Diet (e.g. ad libitum): antibiotic free rabbit diet ad libitum (SQC standard rabbits pellets, produced by Special Diets Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-21 °C.
- Humidity (%): 43-73 % with the exception of one occasion when the recorded relative humidity exceeded the protocol specific upper limit. This deviation is considered not to have affected the outcome of the study.
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours after patch removal

Number of animals:

3 females

Details on study design:

Initially, one animal was dosed in a preliminary screen to estimate the potential irritancy of the test article. Twenty four hours after patch removal a further 2 animals were dosed.

TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 2.5 cm square
- Type of wrap if used: surgical lint held in position with "Elastoplast" elastic adhesive bandage 7.5 cm wide.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale (according to OECD guideline No. 404)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time.
At the 24 hour observation, the treated skin site on all 3 animals was free of signs of irritation and remained so at the 48 and 72 hour examination.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corrosive response data for 3 animals at each observation time up to removal of animals from the test

 

Score at time point / Reversibility	Erythema Max. score 4	Oedema Max. score 4
1 h	0.0 / 2.0 / 2.0	1.0 / 0.0 / 1.0
24 h	0.0 / 0.0 / 0.0	0.0 / 0.0 / 0.0
48 h	0.0 / 0.0 / 0.0	0.0 / 0.0 / 0.0
72 h	0.0 / 0.0 / 0.0	0.0 / 0.0 / 0.0
Average 24h, 48h, 72h	0.0 / 0.0 / 0.0	0.0 / 0.0 / 0.0
Reversibility*)	-	-
Average time (day) for reversion**	-	-

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

**): correspond to the last day for which skin irritation signs in the last animal were observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the mean scores calculated within 3 scoring times (24, 48 and 72 hours) for each animal were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.

Executive summary:

In a dermal irritation study performed similarly to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted ST 06 C 93 was dermally applied on the shaved skin of the dorsal surface of the trunk of 3 females New Zealand White rabbits.Test sites were covered with a semi-occlusive dressing for 4 hours.

Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after the removal of the patch.

The mean scores calculated within 3 scoring times (24, 48 and 72 hours) for each animal were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.

One hour after patch removal, a well-defined erythema was noted at the treated sites on 2 animals. This response was accompanied by a barely perceptible oedema in one animal. Very slight oedema was also apparent in the third rabbit at this time. No signs of irritation were observed at 24, 48 and 72 hours.

 

Therefore, ST 06 C 93 does not require a classification as irritant to the skin according to the the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.