Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 14, 1999 - June 17, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

EC Number:

944-482-9

Molecular formula:

C13H20O

IUPAC Name:

Reaction mass of 1-(3,3-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one and 1-(5,5-dimethylcyclohex-1-en-1-yl)pent-4-en-1-one

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: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne
- Age at study initiation: 13 weeks
- Weight at study initiation: male: 3034g; females: 2447 and 2861g
- Housing: Individually in stainless steel cages.
- Diet: Free access to pelleted standard Provimi Kliba 3418 rabbit maintenance (batch no. 64/99)
- Water: Free access to community tap water from Itingen
- Acclimation period: under laboratory conditions after health examination for 6 days.

ENVIRONMENTAL CONDITIONS (target ranges)
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

1 male
2 females

Details on study design:

TEST SITE
Approximately three days before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 cm^2 (10 cm x 10 cm). The skin of the animals was examined approximately 24 hours before treatment, and, if necessary, regrown fur was again clipped.

TREATMENT
On the day of treatment, the test substance was applied approximately 6 cm^2 of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze and the gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed and the skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the guidelines. If evident, corrosive or staining properties of the test substance were described and recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

male

Time point:

other: mean 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2 and #3 (females)

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

male

Time point:

other: mean 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2 and #3 (females)

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

In the male animal very slight erythema and very slight oedema were observed until 24 hours after treatment. All signs of irritation were reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed.

Other effects:

No staining by the test substance of the treated skin was observed.

Any other information on results incl. tables

The body weights of all rabbits were considered to be within the normal range of variability.

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified.

Remarks:

According to Regulation (EC) No. 1272/2008 and its updates

Conclusions:

In a skin irritation study with 3 rabbits, performed according to OECD 404 guideline and GLP principles, very slight erythema and very slight oedema was observed in one male. All signs of irritation were fully reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed. The substance also does not need to be classified according to GHS.

Executive summary:

The substance was tested for 4 hours in a skin irritation test in 3 rabbits according to OECD TG 404 test guideline and GLP principles.

In the male animal very slight erythema and very slight oedema were observed until 24 hours after treatment. All signs of irritation were reversible within 48 hours. The female animals showed no irritation. No corrosive effects were observed.

No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.

Based on the results, the substance does not need to be classified for skin irritation/skin corrosion according to Regulation (EC) No. 1272/2008 and GHS.