Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 Oct 1997 - 27 May 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD) (test substance purity not specified).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted 17 July, 1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
adopted 30 Sept 1996
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Epicol G24 G2, C12/14alpha-Epoxid, ringgeöffnet mit Glykol, SAT970397
- Analytical purity: not specified
- Lot/batch No.: 10017020
- Expiration date of the lot/batch: 1998-01-20
- Storage condition of test material: at room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 30 days
- Weight at study initiation: 303g ± 19g
- Housing: in Makrolon Type 4 cages with up to 5 animals per cage in semi-barrier conditions
- Diet: Altromin 1322, standard diet for guinea pigs, ad libitum
- Water: tap water, municipal supply Bitterfeld in Makrolon bottles, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24°C
- Humidity (%): 30 - 65%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
undiluted
No. of animals per dose:
control - 10
test group - 20
Details on study design:
RANGE FINDING TESTS: A dermal tolerance test was done for the test substance. Shaved skin of 2 guine pigs was treated with different aqueous dilutions of the substance for 24 hours.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: filter papaer soaked with 0.5 g test substance
- Control group: filter paper with occlusive dressing
- Site: left flank
- Frequency of applications: every 7 days
- Duration: 0-21 days
- Concentrations: undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 hours
- Test groups: filter paper soaked with 0.5 g test substance
- Control group: filter paper soaked with 0.5 g test substance
- Site: right flank
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 and 48 hours

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin reactions and no differences in skin-fold thickness
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin reactions and no differences in skin-fold thickness.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin reactions and no differences in skin-fold thickness
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no skin reactions and no differences in skin-fold thickness.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified