Reaction mass of 1-methyl-3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde and 1-methyl-4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 8, 1999 - June 17, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1992)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl-4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde

EC Number:

257-942-2

EC Name:

1-methyl-4-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde

Cas Number:

52475-86-2

Molecular formula:

C14H22O

IUPAC Name:

1-methyl-4-(4-methylpent-3-en-1-yl)cyclohex-3-ene-1-carbaldehyde

Constituent 2

Reference substance name:

1-methyl-3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde

EC Number:

257-941-7

EC Name:

1-methyl-3-(4-methyl-3-pentenyl)cyclohex-3-ene-1-carbaldehyde

Cas Number:

52474-60-9

Molecular formula:

C14H22O

IUPAC Name:

1-methyl-3-(4-methylpent-3-en-1-yl)cyclohex-3-ene-1-carbaldehyde

Specific details on test material used for the study:

- Name of test material (as cited in study report): PRECYCLEMONE B
- Description: Colourless to pale yellow liquid
- Purity: 99.3%
- Batch No.: 9000320077
- Storage condition of test material: In a refrigerator (2-8°C)
- Expiration date of the batch: March 25, 2000

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 13 weeks
- Weight at study initiation: Male: 2989 g; Females: 2669 and 2598 g
- Housing: Animals were housed individually in stainless steel cages
- Diet: Free access to pelleted diet for rabbits (Provimi Kliba 3418)
- Water: Free access to tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 – 23
- 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:

other: Adjacent areas of the untreated skin of each animal served as controls

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

1 male and 2 females

Details on study design:

TEST SUBSTANCE PREPARATION
The substance was applied as such.

TEST SITE
Approximately 3 days before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10x10 cm). The skin of the animals was examined approximately 24 hours before treatment, and, if necessary, regrown fur was again clipped.

APPLICATION
The test substance was applied to approx. 6 square centimeters of the intact skin of the clipped area. It was covered with a 2.5 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
Yes, at the end of the exposure period, using lukewarm tap water.

OBSERVATIONS
- Mortality/Viability: Daily
- Toxicity: Daily
- Body Weight: At start of acclimatization, on the day of application and at termination
- Necropsy: Not applicable
- Irritation:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance.

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

other: Mean value of score at 24, 48 and 72h after patch removal

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

other: Mean value of score at 24, 48 and 72h after patch removal

Score:

0

Max. score:

4

Irritant / corrosive response data:

No signs of irritation were observed.

Other effects:

- All animals had a shiny skin at all readings
- No staining by the test material was observed
- No clinical signs of systemic toxicity were observed
- No mortality occurred
- No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin
- Body weights were within the normal range of variability

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a skin irritation study with rabbits, performed in accordance with OECD 404 (1992) and according to GLP principles, no signs of irritation were observed.

Executive summary:

In a skin irritation study in rabbits, conducted in accordance with OECD 404 (1992), EU Method B.4 (1992) and according to GLP principles, 1 male and 2 female rabbits were semi-occlusively exposed for 4 hours to 0.5 mL of the substance. No signs of irritation nor clinical signs of toxicity were observed. Based on the results of this study, the substance does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.