3-methyl-5-propylcyclohex-2-enone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No guideline specified, no mention of GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

other:

Deviations:

not applicable

Principles of method if other than guideline:

Study rated K4. Information on guideline not available.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-5-propyl-2-cyclohexenone

IUPAC Name:

3-methyl-5-propyl-2-cyclohexenone

Constituent 2

Reference substance name:

celery ketone

IUPAC Name:

celery ketone

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 3-Methyl-5-propyl-2-cyclohexenone
- Substance type: No data
- Physical state: liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: 3-Methyl-5-propyl-2-cyclohexenone (unspecified percentage)
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:

guinea pig

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: No data

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 0.03, 0.1, 0.3, 1, 3, 10, 30 and 100%
- Lot/batch no. (if required): No data
- Purity: No data

Duration of treatment / exposure:

Single application: 24 hours
Repeated application: 21 days

Observation period:

Single application: 24 hours
Repeated application: 21 days

Number of animals:

6-8 per group

Details on study design:

TEST SITE
- Area of exposure: 8 cm squared
- % coverage: No data
- Type of wrap if used: Not applicable

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not applicable

SCORING SYSTEM: Qualitative classification of the degree of skin irritation (see table 2)

Results and discussion

In vivo

Results

Irritation parameter:

other: highest non-irritant concentration

Basis:

mean

Time point:

other: 24 hours

Score:

10

Max. score:

100

Reversibility:

no data

Any other information on results incl. tables

Solvent	Lowest irritant concentration/%	Highest non-irritant concentration/%
Acetone	30	10

Table 1: Skin irritation after single application

Concentration/%	Skin irritation after day number
	7	14	21
100	(+)	++	++
30	(+)	+	+
10	-	-	-
3	-	-	-

Table 2: Skin irritation after repeated daily applications over 21 days

Key:

- = none

(+) = very slight

+ = slight

++ = moderate

+++ = strong

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information single application Criteria used for interpretation of results: EU

Conclusions:

The highest non-irritant concentration 3-methyl-5-propyl-2-cyclohexenone after single and repeated applications to guinea pigs was 10%.

Executive summary:

In an open epicutaneous test for skin irritation in guinea pigs (no guideline specified), the test material, 3-methyl-5-propyl-2-cyclohexenone, did not irritate at concentrations up to and including 10% after a single applications. At 30% and 100% after a single application only "very" slight irritation was observed and after 7 days of continuous application only "very" slight irritation was observed.

Therefore based on the current OECD guidance and considering a single dose, the reaction is not deemed sufficient for classification.