Allyl (cyclohexyloxy)acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Mar 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

4 concentrations of the test substance were tested on each animal

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Allyl (cyclohexyloxy)acetate

EC Number:

272-657-3

EC Name:

Allyl (cyclohexyloxy)acetate

Cas Number:

68901-15-5

Molecular formula:

C11H18O3

IUPAC Name:

allyl (cyclohexyloxy)acetate

Test animals

Species:

rabbit

Strain:

Himalayan

Remarks:

Chbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Animals were housed individually in PPL cages (45 cm x 55 cm) with perforated floor.
- Diet: Altromin 2123, pelleted complete rabbit diet (Chr. Petersen, Ringsted, Denmark), ad libitum
- Water: fresh water, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 6
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: diethyl phthalate

Controls:

other: adjacent areas of skin treated with vehicle served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 1, 5, 25 and 100%

Duration of treatment / exposure:

4 h

Observation period:

72 h; Since all observed effects had completely reversed at the 48-h reading, the study was discontinued after the 72 h reading.
Reading time points: 30 min and 24, 48 and 72 h

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: area on the back (10 cm x 10 cm) divided into two anterior and two posterior treatment sites and one test site at the center.
- Type of wrap: The test substance of one of the test concentrations or the vehicle was applied to the skin and covered with gauze packs (2.5 cm x 2.5 cm). The gauze packs were secured with a cross of 1 cm wide adhesive tape and fixed with Scanpor tape (7.5 cm width).

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance with soap and lukewarm water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: 100%

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: 100%

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: 100%

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: 100%

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: at test substance concentration of 1, 5 and 25%

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: at test substance concentration of 1, 5, 25 and 100%

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: at test substance concentration of 1, 5, 25 and 100%

Results 8

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: at test substance concentration of 1, 5, 25 and 100%

Results 9

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: at test substance concentration of 1, 5, 25 and 100%

Any other information on results incl. tables

Table 1. Results of the skin irritation study.

Rabbit no.	Test concentration		Erythema				Individual mean values	Edema				Individual mean values
			½ h	24 h	48 h	72 h		½ h	24 h	48 h	72 h
1	AL	100%	2	1	0	0	0.33	0	0	0	0	0
2	PL	100%	2	1	0	0	0.33	0	0	0	0	0
3	PL	100%	1	0	0	0	0	0	0	0	0	0
4	PR	100%	0	0	0	0	0	0	0	0	0	0

AL: Anterior left treatment site

PL: Posterior left treatment site

RP: Posterior right treatment site

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this skin irritation study in rabbits the test substance was not irritating to the skin.