4-methyl-3-decen-5-ol

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

12th June 1989 to 13th July 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A GLP study performed in accordance with generally accepted scientific principles, with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Type of study / information:

This endpoint provideds information determined from an in vivo photoallergenicity study. The test material was applied using a similar procedure to the standard maximisation test, however, the test sites were also subjected to an irratiation regimen during the course of the test to determine the photoallerginicity.

Test guideline

Qualifier:

according to guideline

Guideline:

other: CTFA Safety Testing Guidelines, The Cosmetic, Toiletry and Fragrance Association, Inc. Washington, D.C. 20005; "Guidelines for Evaluating Photodermatitis" pp. 9-11

Deviations:

no

Principles of method if other than guideline:

Ten albino female guinea pigs were used as a control group and twenty females were used in the treatment group (using the highest non-irritating concentration of 30 %). The reactions to the skin of the irradiated and not radiated test sites were compared.

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

Results and discussion

Any other information on results incl. tables

Erythema and Edema Scoring

- All animals were scored 0 for both the irradiated and non-radiated test sites at each of the concentrations tested.

 

Local Symptoms

- Control and the test group displayed the same symptoms:

Erythema and edema were observed on all application areas from Day 2 to 7.

Necrosis was observed from Day 8 to 16 and exfoliation from Day 17 until termination on Day 25.

- Epidermal Application:

No symptoms were observed in either the test or control groups.

 

Mortality/Viability

One female died spontaneously on Day 23.

 

Macroscopical Findings

- The lungs were not collapsed but reddened in the female found dead on day 23.

 

Clinical Signs

- No systemic symptoms were observed.

 

Body Weights

- Two females lost weight during the acclimatization period.

- One female lost weight during treatment.

Table 2. Body Weights (g)

Acclimatisation		Group 1	Group 2
Day 1, Week 1	Mean	431.6	432.7
	SD	17.5	16.9
	N	10	20
Treatment
Day 1, Week 1	Mean	466.3	474.
	SD	27.3	29.7
	N	10	20
Day 25, Week 4	Mean	530.4	544.7
	SD	48.0	36.2
	N	10	19

Applicant's summary and conclusion

Conclusions:

The test material was determined to be not sensitising in the photoallergenic guinea pig maximisation test.

Executive summary:

The photoallergenicity caused by exposure to the test material combined with irradiation was determined in a GLP compliant study conducted in accordance with generally accepted scientific principles. The test material was applied as a 10% dilution in acetone/ethanol (1:1) for the induction, while the test material was applied at concentrations of 30, 10, 3 and 1 % for the challenge. During the challenge animals were exposed to the test material on both the left and right flanks, where only the left was irradiated with UV-A light.

Under the conditions of the study no skin responses were observed after the induction or on the irradiated and non-irradiated challenge sites. Based on the results, it can be concluded that the test material possesses no photoallergic potential for guinea pigs and thus the likelihood that the test material would cause a reaction in humans is low.