Reaction mass of (1R)‐1‐[(1S)‐3,3‐dimethylcyclohexyl]ethyl relacetate and (1R,2R)‐2,6,6‐trimethylcycloheptyl rel‐acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 Aug 1983 to 02 Sep 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

non-GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Bioassay Systems Protocol, Primary Dermal Irritation Test

Version / remarks:

EPA-1982

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

(1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl rel-acetate

Molecular formula:

C12H22O2

IUPAC Name:

(1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl rel-acetate

Constituent 2

Reference substance name:

(1R,2R)‐2,6,6‐trimethylcycloheptyl rel‐acetate

Molecular formula:

C12H22O2

IUPAC Name:

(1R,2R)‐2,6,6‐trimethylcycloheptyl rel‐acetate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Pine Acres Rabbitry W. Brattleboro, VT
- Age at study initiation: 11 - 15 weeks
- Weight at study initiation: 2.5 - 3.0 kg
- Diet: Agway Prolab Rabbit Formula, Lot # Wl 32189

IN-LIFE DATES: From 30 Aug 1983 To 02 Sep 1983

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL per 1 inch square, four gauze pads per animal
- Amount applied for the negative control: an 1 inch square gauze (sponge) pad per animal without test material.

Duration of treatment / exposure:

4 hours

Observation period:

30 to 60 minutes, 24, 48 and 72 hours

Number of animals:

6

Details on study design:

TREATMENT PROCEDURE
Approximately 24 hours prior to treatment, the fur on the sides of each animal was closely clipped with care taken not to abrade the skin. A 0.5 mL aliquot of the test sample was introduced under a 1 inch x 1 inch gauze pad previously secured to the test site with surgical tape. Four pads were enployed, each one for a separate sample. Two different test sample pads were placed on the left side, and two more different test sample pads were placed on the right side. A 1 inch x 1 inch gauze pad was applied to an untreated site on the left side of each animal to serve as the control. The animals were then wrapped with an impervious covering (plastic wrap) and then stockinette to prevent removal of the patches by the animal. Patches were removed after 4 hours and the test and control sites were examined for erythema/eschar and edema formation 30 - 60 minutes after patch removal. The test and control sites were again examined at 24, 48, and 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No erythema and no oedema were observed at any of the patch sites on all six animals. All patch sites had scores of 0 during the observation periode.

Any other information on results incl. tables

Table 1: Primary dermal irritation test: observations Erythema/Oedema

		Test site				Control Site
Animal #	Weight (kg) 0hr	30-60 min	24 hr	48 hr	72 hr	30-60 min	24 hr	48 hr	72 hr
1	2.9	0/0	0/0	0/0	0/0	0/0	0/0	0/0	0/0
2	2.6	0/0	0/0	0/0	0/0	0/0	0/0	0/0	0/0
3	2.9	0/0	0/0	0/0	0/0	0/0	0/0	0/0	0/0
4	2.7	0/0	0/0	0/0	0/0	0/0	0/0	0/0	0/0
5	2.5	0/0	0/0	0/0	0/0	0/0	0/0	0/0	0/0
6	3.0	0/0	0/0	0/0	0/0	0/0	0/0	0/0	0/0

 

Applicant's summary and conclusion

Interpretation of results:

other: not skin irritating

Remarks:

according to EU CLP (EC No 1272/2008 and its amendments)

Conclusions:

The substance does not cause skin irritation in the dermal irritation study in rabbits (OECD TG 404).

Executive summary:

The skin (corrosion and) irritation potential of the substance was determined in vivo in a study equivalent to OECD TG 404. A volume of 0.5 mL of unchanged substance per gauze pad with a total of 4 gauze pads per animal was administered to the clipped back of 6 male adult albino rabbits (New-Zealand White) for 4 hours under semi-occlusive conditions. The patch sites were observed for signs of erythema and oedema, and scored according to the Draize scale at 30 to 60 minutes, 24, 48 and 72 hours after patch removal.

No oedema or erythema was observed at any of the patch sites on all six (6) animals. All patch sites had scores of 0 during the observation period. In conclusion, the substance does not cause skin irritation in the dermal irritation study in rabbits.