Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: No guideline for study, performed by Industrial Bio Test Inc. (IBT)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1958
Report Date:
1958

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
50 volunteers were exposed dermally to 1% or 10% solutions of both test materials. A series of 9 patch applications over three weeks and a single challenge patch two weeks after the induction was performed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Epoxy Resin X2638.1 (Dow ET-337)
Epoxy Resin X2638.3 (Dow ET-338)

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
50 individuals with a mix of race, sex and age.
Route of administration:
dermal
Details on study design:
A pilot study was performed on ten individuals succeeded by a principle study with 40 individuals. A series of nine patch applications were scheduled over a three week period. Two weeks following the ninth application of each test material a single patch application was made to elicit and skin sensitization reactions.

Results and discussion

Results of examinations:
Upon repeated application to normal human skin, sesame oil dilutions containing up to 10% Dow ET-337 or Dow ET-338 caused a skin irritation incidence of approximately 1.8%; no reactions were noted in response to challenge applications.

Any other information on results incl. tables

 

Number of Subjects

Number of Applications

Number of Reactions

4

3

2

1

0

Primary Skin

Male

Female

30

20

270

180

1

0

4

2

0

1

0

0

265

177

 

Total

50

450

1

6

1

0

442

 

Skin Sensitization

Male

Female

30

20

32

20

0

0

0

0

0

0

0

0

32

20

 

Total

50

50

0

0

0

0

50

Applicant's summary and conclusion

Conclusions:
Upon repeated application to normal human skin, sesame oil dilutions containing up to 10% Dow ET-337 or Dow ET-338 caused a skin irritation incidence of approximately 1.8%; no reactions were noted in response to challenge applications.