Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10.11.98 - 15.01.99
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in GLP compliance and in accordance with an OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): AGEE 623 Amine
- Physical state: dark, liquid
- Analytical purity: 80.6 %
- Composition of test material, percentage of components: batch contains 20% solvent
- Lot/batch No.: T29844
- Expiration date of the lot/batch: December 31, 1999
- Stability under test conditions: stable for at least 2 hours in water and organic solvents
- Storage condition of test material: 4 °C, light protected in the closed container
- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hsd Poc: DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: approx. 4-5 weeks
- Weight at study initiation: 300-316 g
- Housing: groups of max. 10 in Terluran- cages
- Diet (e.g. ad libitum): Feeding ad libitum, Altromin 3122 maintenance diet for guinea pigs, rich in crude fiber, totally-pathogen-free-TPF.
- Water (e.g. ad libitum): Free access to tap water ( drinking water, municipal residue control, microbiol. controlled periodically).


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3° C
- Humidity (%): 55± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): 12: 12 hours

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
cotton seed oil
Concentration / amount:
For the intradermal injection and topical application (induction- first and second
stage) the test item was applied at a 50% concentration. For challenge
application a 10% concentration was chosen ( diluted with Cottonseed Oil).
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
cotton seed oil
Concentration / amount:
For the intradermal injection and topical application (induction- first and second
stage) the test item was applied at a 50% concentration. For challenge
application a 10% concentration was chosen ( diluted with Cottonseed Oil).
No. of animals per dose:
test: 10 females
control: 5 females
Positive control substance(s):
yes
Remarks:
Mercaptobenzothiazole

Results and discussion

In vivo (non-LLNA)

Results
Hours after challenge:
24
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Any other information on results incl. tables

The results for the experimental animals at the challenge phase (10% concentration of the test item) were compared with the results for the control animals. None of the 10 animals of the test group showed allergic skin reactions until 72 hours after patch removal as compared to the intraspecific application of Cottonseed Oil and to the animals of the control group. The maximum percentage of animals sensitized was 0 %. Animals of both groups survived throughout the test period. Animals of the test group showed reduced weight gain as compared to historical data and the animals ofthe control group

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this sensitization test it can be stated that
the test item AGEE 623 Amine caused no reactions identified as sensitization.
According to EEC criteria for classification (93/21/EEC) no labelling is necessary
as the sensitization rate was below 30%.