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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientific publication with restrictions compared to Guideline Study (limited documentation)

Data source

Reference
Reference Type:
publication
Title:
Sensitizing capacity and cross-reactivity of phenyl glycidyl ether studied in the guinea-pig maximization test
Author:
Pontén, Ann Zimerson, Erik Bruze, Magnus
Year:
2009
Bibliographic source:
Pontén, A., Zimerson, E. and Bruze, M. (2009), Sensitizing capacity and cross-reactivity of phenyl glycidyl ether studied in the guinea-pig maximization test. Contact Dermatitis, 60: 79–84. doi: 10.1111/j.1600-0536.2008.01475.x

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
PGE
IUPAC Name:
PGE

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M&B A/S, Ry, Denmark
- Age at study initiation: no data
- Weight at study initiation: 400 +/- 20 g
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: day 0 To: day 23

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
PGE in propylene glycol

Intradermal induction: 0.55 % w/v;
Topical induction: 0.83 % w/v
Challange I: 1.7 % w/v
Challange II (cross reactions): 1.7 % w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
propylene glycol
Concentration / amount:
PGE in propylene glycol

Intradermal induction: 0.55 % w/v;
Topical induction: 0.83 % w/v
Challange I: 1.7 % w/v
Challange II (cross reactions): 1.7 % w/v
No. of animals per dose:
24
Positive control substance(s):
yes
Remarks:
2-methylol phenol

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction 0.55 and 0.83 %w/v, challenge 1.7 % w/v
No. with + reactions:
23
Total no. in group:
24
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction 0.55 and 0.83 %w/v, challenge 1.7 % w/v. No with. + reactions: 23.0. Total no. in groups: 24.0.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
PGE is a skin sensitizer in the GPMT test.