Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976-05-07
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To check the test substance for signs of skin irritation
- Short description of test conditions: A repeated insult patch test using 56 human panelists (males & females 18 to over 60 years of age) was conducted on 0.8% 1-tertbutoxy-2,3-epoxyporpane in perchloroethylene. Each inhibitor solution was applied nine times in three weeks to the upper arms of the panelists. After a two week incubation period, challenge applications of the test solutions and the solvents were made
- Parameters analysed / observed: Panelists were checked for signs of skin irritation
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 56
- Sex: Males and Females
- Age: 18 to over 60 years
- Race: Humans
Route of administration:
dermal
Details on study design:
- A repeated insult patch test using 56 human panelists (males & females 18 to over 60 years of age) was conducted on 0.8% 1-tertbutoxy-2,3-epoxyporpane in perchloroethylene. Each inhibitor solution was applied nine times in three weeks to the upper arms of the panelists. After a two week incubation period, challenge applications of the test solutions and the solvents were made

Results and discussion

Results of examinations:
- Two panelists exhibited positive reactions to 1-tert-butoxy-2,3-epoxypropane. One reaction was mild with redness and swelling confined to the test site. The other reaction was quite strong and spread beyond the test site.

Applicant's summary and conclusion

Conclusions:
In a repeated human insult patch test, 0.8% 1 -tert-butoxy-2,3 -epoxypropane in perchloroethylene was applied to the upper arms of 56 human panelists (males and females, 18 to over 60 years of age). The reactions were observed after a two week incubation period. Two panelists exhibited positive reactions to 1-tert-butoxy-2,3-epoxypropane. One reaction was mild with redness and swelling confined to the test site. The other reaction was quite strong and spread beyond the test site. Thus, it was recommended that if 1-tert-butoxy-2,3-epoxyporpane is incorporated into a product, the inhibitor and the product should be handled on a no skin contact basis. Such a product should not be used as dry-cleaning solution or as a cold cleaning solution (bucket solvent) were skin contact is likely.
Executive summary:

In a repeated human insult patch test, 0.8% 1 -tert-butoxy-2,3 -epoxypropane in perchloroethylene was applied to the upper arms of 56 human panelists (males and females, 18 to over 60 years of age). The reactions were observed after a two week incubation period. Two panelists exhibited positive reactions to 1-tert-butoxy-2,3-epoxypropane. One reaction was mild with redness and swelling confined to the test site. The other reaction was quite strong and spread beyond the test site. Thus, it was recommended that if 1-tert-butoxy-2,3-epoxyporpane is incorporated into a product, the inhibitor and the product should be handled on a no skin contact basis. Such a product should not be used as dry-cleaning solution or as a cold cleaning solution (bucket solvent) were skin contact is likely.