4-methyl-3-decen-5-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8th August 2000 to 5th September 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-methyl-3-decen-5-ol

EC Number:

279-815-0

EC Name:

4-methyl-3-decen-5-ol

Cas Number:

81782-77-6

Molecular formula:

C11H22O

IUPAC Name:

4-methyldec-3-en-5-ol

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, France- Age at study initiation: 14 weeks (males) and 15 weeks (females)- Weight at study initiation: 2.7 - 2.9 kg- Housing: Individually in stainless steel cages- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum, batch no. 30/00, provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Haysticks, QS n. 137/00, provided by Eberle Nafag AG, CH-9200 Gossau- Water (e.g. ad libitum): Tap water from Füllinsdorf, ad libitum- Acclimation period: 6 days under laboratory conditionsENVIRONMENTAL CONDITIONS- Temperature (°C): 21 - 23.5 °C- Humidity (%): 44 - 79 %- Air changes (per hr): 10 - 15 charges per hour- Photoperiod (hrs dark / hrs light): 12 hrs light and 12 hours dark.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

Duration of exposure: 4 hours

Observation period:

A total of 21 days at the following time points: 1, 24, 48 and 72 hours and 7, 10, 14, 17 and 21 days.

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE- Area of exposure: 6 cm² (2.5 x 2.5 cm)- Type of wrap if used: Approximately 6 cm² of surgical gauze, covered with a semi-occlusive dressing, which was wrapped around the abdomen and anchored with tape.REMOVAL OF TEST SUBSTANCE- Washing (if done): Yes with lukewarm tap water.- Time after start of exposure: 4 hours post application.OBSERVATIONS:Mortality/Viability - Daily until termination of the test.Clinical Signs - Daily until termination of the test.Body weight - At the start of acclimatisation, day of application and at termination of the test.No necropsy was performed.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.56

Max. score:

4

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

Irritation scores were calculated as a mean of the three animals over the three time point 24, 48 and 72 hours for both erythema and oedema.Slight scaling was observed in all animals at day 7 all were recoved by day 21

Other effects:

Mortality - none occurred.Clinical Signs - no systemic signs of toxicity.Body Weight - all rabbits were considered to be within the normal range of variability.Colouration - no staining to the skin was observed.Corrosion - no irreversible alterations of the treated skin were observed nor were corrosion effects evident on the skin.

Any other information on results incl. tables

Table 2. Individual Skin Irritation Scores.

Animal	Sex	Evaluation Interval	Erythema	Oedema	Cumulative		Scaling
					Score	Mean
73	M	1 hour	2	2	4	3.33	0
74	F		2	1	3		0
75	F		2	1	3		0
73	M	24 hours	2	1	3	3.00	0
74	F		2	1	3		0
75	F		2	1	3		0
73	M	48 hours	1	1	2	2.00	0
74	F		2	1	3		0
75	F		1	0	1		1
73	M	72 hours	1	0	1	0.67	0
74	F		1	0	1		0
75	F		0	0	0		1
73	M	7 days	0	0	0	0.00	2
74	F		0	0	0		1
75	F		0	0	0		1
73	M	10 days	0	0	0	0.00	1
74	F		0	0	0		1
75	F		0	0	0		0
73	M	14 days	0	0	0	0.00	0
74	F		0	0	0		1
75	F		0	0	0		0
73	M	17 days	0	0	0	0.00	0
74	F		0	0	0		1
75	F		0	0	0		0
73	M	21 days	0	0	0	0.00	0
74	F		0	0	0		0
75	F		0	0	0		0

 

Table 3. Mean Skin Irritation Scores After 48 and 72 Hours.

Animal	Sex	Erythema	Oedema
73	M	1.33	0.67
74	F	1.67	0.67
75	F	1.00	0.33
Mean		1.33	0.56

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The test material was determined to be not irritating. Slight erythema (1.33) and oedema (0.56) were observed, however the effects were not severe enough to trigger a classification and all effects were fully reversible within 21 days.

Executive summary:

In a GLP compliant skin irritation study, performed to standardised guidelines OECD 404 and EU method B.4 the irritation potential of the test material was determined in a 4 hour semi-occlusive test. Three rabbits were exposed to 0.5 mL of the unchanged test material for a duration of 4 hours and observed for 21 days. The mean scores from observation at 24, 48 and 72 hours were used to determine a classification. Slight erythema 1.33 and oedema 0.56 were observed, however, the effects were not severe and were fully reverse within 21 days. Under the conditions of the test, the test material was determined to be not irritating, and no classification is required under Regulation 1272/2008.