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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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)

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.