Butanal, 3-methyl-, reaction products with 3-methyl-3-buten-1-ol, distn. lights

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Secondary literature, peer-reviewed

Data source

Reference

Reference Type:

secondary source

Title:

Sensitization and irritation studies with fragrance materials

Author:

Givaudan

Year:

1965

Bibliographic source:

Cited in: Anonymous (1965); Fragrance raw materials monographs, Food. Chem. Toxicol. 30, Suppl. Issue VIII, 1992, p. 121S-122S; Cited in: RIFM Database, Location 14510

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Repeated Insult Patch test conducted with volunteers.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

no further data provided

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 51
- Sex: 31 Females and 20 Males
- Age: 17 - 67 years old

Controls:

no data

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: dimethyl phthalate
- Concentrations: 3% for the first 3 inductions, 5% for remainder of study
- Volume applied: 0.5 mL
- Removal of test substance: 48 hours after application
- Other: A 0.5 ml aliquot of 3% tetrahydro-4-methyl-2-(2-methylpropen-1-yl)pyran in dimethyl phthalate was applied to a patch which was then applied to the deltoid area for 48-72 hours under occlusion. Ten consecutive induction applications were made to alternate sites in the deltoid area. The first 3 induction applications were made with 3% but the concentration was increased to 5% for the remainder of the study. After a 2-week rest period, a 48-hour occluded challenge application was made with 5% tetrahydro-4-methyl-2-(2-methylpropen-1-yl)pyran in dimethyl phthalate. Reactions were read at patch removal and again 24 hours after patch removal.

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 5
- Number of subjects with negative reactions: 46
One other patient's reactions at induction patches 9 and 10 were attributed to "skin fatigue".

No irritating reactions were observed after application of 3% test substance in 5 volunteers.