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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data available as short summary from a secondary source beeing cited in a peer-reviewed publication

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Report on human maximization studies.
Author:
Epstein WL
Year:
1976
Bibliographic source:
RIFM FEMA Database, Location 1796
Report Date:
1976
Reference Type:
secondary source
Title:
Report on human maximization studies.
Author:
Epstein WL
Year:
1976
Bibliographic source:
cited in: Opdyke DLJ, Food Cosmet. Toxicol., Vol 17, p. 909, 1979
Reference Type:
publication
Title:
Fragrance material review on tetrahydrolinalool
Author:
Lapczynski et al.
Year:
2008
Bibliographic source:
Food Chem. Toxicol.; 46; 286-288

Materials and methods

Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Human maximization test was conducted on 32 healthy volunteers
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Subjects:
- Number of subjects exposed: 32
- Sex: unspecified
- Age: 18 +
Clinical history:
- Other: stated healthy, no further information provided
Controls:
Vehicle (petrolatum) and SLS controls were placed on the left and on the right.
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)
Human maximization test

ADMINISTRATION
- Type of application: occlusive, 5 alternate-day 48-hour periods
- Vehicle / solvent: Petrolatum
- Concentrations: 4%
- Dermal load: 2760 µg/cm2
- Testing/scoring schedule: Following a 10- to 14-day rest period, a challenge patch of the test material was applied to a fresh site for 48 hours under occlusion
- Other: The patch sites were pretreated for 24 hours with 5% aqueous SLS under occlusion for the initial patch only. Prior to the challenge, 5% SLS was applied to the test sites for 30 minutes under occlusion on the left side of the back, while the test materials were applied without SLS treatment on the right side.

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: no effects reported

Any other information on results incl. tables

Pretest: No dermal irritation was observed.

Main test: No sensitization reactions were observed

Applicant's summary and conclusion