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Registration Dossier
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EC number: 701-263-0 | CAS number: -
Sensitisation data (human)
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:
- 1 958
- 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 substance name:
- Reaction mass of 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]dioxirane and [2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane and [2,2'-[methylenebis(2,1-phenyleneoxymethylene)]dioxirane
- EC Number:
- 701-263-0
- Cas Number:
- 9003-36-5
- Molecular formula:
- C6 H6. C3 H5 Cl . C H2 O)x
- IUPAC Name:
- Reaction mass of 2,2'-[methylenebis(4,1-phenyleneoxymethylene)]dioxirane and [2-({2-[4-(oxiran-2-ylmethoxy)benzyl]phenoxy}methyl)oxirane and [2,2'-[methylenebis(2,1-phenyleneoxymethylene)]dioxirane
- Details on test material:
- Epoxy Resin X2638.1 (Dow ET-337)
Epoxy Resin X2638.3 (Dow ET-338)
Constituent 1
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.
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