Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
01 November 1967 to 11 December 1967
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The methodology and results were reported in very limited detail. It was not possible to assess the quality of the reported results from the data presented. From the limited information available, the study appears to have been conducted in compliance with good scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test material was tested in a concentrated form in a closed epicutaneous lobule test according to Bloch and Jadassohn method in 100 subjects, 28 of whom were skin sensitive and allergic. The tests were applied on the back and inside of the upper arm. Readings, of skin reaction, were taken after 24 hours and follow-up after 48 and 72 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report: 2-phenoxyethyl-2-methylpropionat

Method

Type of population:
not specified
Subjects:
- Number of subjects exposed: 100
- Known allergies: 28 of the subjects were skin sensitive and allergic
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
not specified
Details on exposure:
The concentrated test material was applied to the back and inside of the upper arm and covered in a humid chamber.
Examinations:
- Dermal irritation: Readings were taken after 24 hours and then after 48 and 72 hours.

Results and discussion

Results of examinations:
- Dermal irritation: No case of skin irritation was noted in any of the subjects. Since the specimens were tested in concentrated form, under extreme test conditions (humid chamber), it was concluded that toxic effects on human skin can be excluded.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the test, the test material did no elicit any reaction in any of the 100 subjects. Therefore the test material is not considered to the irritating to humans.
Executive summary:

The skin irritation potential of the test material was examined by subjecting 100 people to a concentrated form in a closed epicutaneous lobule test, conducted according to the Bloch and Jadassohn method. Twenty eight of the subjects were skin sensitive and allergic. Patches were applied on the back and inside of the upper arm. Dermal readings were taken after 24 hours and then after 48 and 72 hours. During the course of the study no case of skin irritation was noted in any of the subjects. Since the specimens were tested in concentrated form, under extreme test conditions (covering in humid chamber), it was concluded that toxic effects on human skin can be excluded.