Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1973
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Type of study / information:
study result
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
human patch test on 60 volunteers
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-5-phenylpent-2-enenitrile
EC Number:
299-682-2
EC Name:
3-methyl-5-phenylpent-2-enenitrile
Cas Number:
93893-89-1
Molecular formula:
C12 H13 N
IUPAC Name:
(2E)-3-methyl-5-phenylpent-2-enenitrile

Method

Ethical approval:
not specified
Details on study design:
Patches were applied to the probands' skin (sites on the backs and upper arms) for 24 h under occlusion.
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: patch test

TYPE OF EXPOSURE MEASUREMENT: Exposure pads

EXPOSURE LEVELS: 10 % suspension in olive oil

EXPOSURE PERIOD: 24 h

POSTEXPOSURE PERIOD: 72 h (observations were performed after 24, 48 and 72 hours)

Results and discussion

Results:
No signs of irriation were observed.

Applicant's summary and conclusion

Conclusions:
The test substance at a concentration of 10 % was not irritating to the skin.
Executive summary:

The test material at a concentration of 10 % in olive oil was applied to skin sites on the backs and upper arms of 60 volunteers under occlusion. The patches were removed after 24 hours and skin reactions were observed 24, 48 and 72 hours thereafter. As a result, no skin reactions were recorded and thus it was concluded that the test substance was not irritating at a concentration of 10 %.