Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, GLP-compliant
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
; see comments
Principles of method if other than guideline:
The substance could not be prepared in an injectable form (the test laboratory confirmed that a range of solvents were tried). Therefore for the first induction the substance was applied dermally over the site where adjuvant had been injected. Both topical induction stages involved wetting of the skin with aqueous sodium lauryl sulphate followed by a 48 hour application of the test substance under an occlusive dressing
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: amber liquid
Details on test material:
- Name of test material: HTP-103
- Physical state: light yellow liquid
- Lot/batch No.: 87A006P251, received at IRI on 23 November 1988
- Stability under test conditions: stable
- Storage condition of test material: in the dark under ambient conditions

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, Darly Oaks, Newchurch, Burton-on-Trent, Staffordshire
- Age at study initiation: less than one year old
- Weight at study initiation: 370-447 g
- Housing: gang housing
- Diet: FDI Guinea Pig Diet, supplied by Special Diets Services (I Stepfield, Witham, Essex, CM8 3AD), supplemented with hay and allowed food
- Water (e.g. ad libitum): tap water
- Acclimatisation period: 7 days prior to test commencement

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 51%
- Photoperiod (hrs dark / hrs light): A 12 h light/dark cycle was in operation (light hours 0700-1900 h)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: The substance could not be prepared in an injectable form (the test laboratory confirmed that a range of solvents were tried). Therefore for the first induction the substance was applied dermally over the site where adjuvant had been injected. Both topica
Vehicle:
paraffin oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
- Topical: 25% v/v in paraffin oil

Concentration of test material and vehicle used for each challenge:
- 10% v/v in paraffin oil
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
- Topical: 25% v/v in paraffin oil

Concentration of test material and vehicle used for each challenge:
- 10% v/v in paraffin oil
No. of animals per dose:
- Number of animals in test group: 20
- Number of animals in negative control group: 20
Details on study design:
The substance could not be prepared in an injectable form (the test laboratory confirmed that a range of solvents were tried). Therefore for the first induction the substance was applied dermally over the site where adjuvant had been injected. Both topical induction stages involved wetting of the skin with aqueous sodium lauryl sulphate followed by a 48 hour application of the test substance under an occlusive dressing.
Positive control substance(s):
yes
Remarks:
Positive control substance: 2,4-dinitro-chlorobenzene (DNCB)

Results and discussion

Positive control results:
Checked at 6 monthly intervals. The most recent positive control test with DNCB was completed on 16 December 1988 when 100% of the test group animals reacted positively.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Dose Ranging Test for Induction:

Only slight reactions were noted at 2 sites treated topically with the test material at one concentration only, 25% v/v in paraffin oil. A concentration of 25% v/v in paraffin oil was selected for the topical application (phases 1 and 2) of induction in the test group.

Main Test - Induction:

Moderate irritation was noted in the test group after the first topical application, with slight reactions after the second application. The control groups reacted slightly after the first application only.

Dose Ranging Test for Challenge:

Slight reactions.were noted in both guinea pigs at a concentration of 25% v/v in paraffin oil. A concentration of 10% v/v in paraffin oil was selected for challenge.

Main Test - Challenge:

Following challenge with the test item at a concentration of 10% v/v, none of the 20 test group animals showed positive reactions to this application. None of the 20 control group animals, which had previously only been exposed to the vehicle, paraffin oil, showed a positive reaction to this application.

Body Weights:

Body weights were recorded at main test commencement and on test completion. Body weight gains were acceptable.

Clinical Signs:

No clinical signs, other than skin reactions induced by treatment, were noted.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item did not show a sensitization reaction in guinea pigs.
Executive summary:

The skin sensitization test was performed on guinea pigs according to EU-testing method B.6. The substance could not be prepared in an injectable form (the test laboratory confirmed that a range of solvents were tried). Therefore for the first induction the substance was applied dermally over the site where adjuvant had been injected. Both topical induction stages involved wetting of the skin with aqueous sodium lauryl sulphate followed by a 48 hour application of the test substance under an occlusive dressing. Satisfactory skin responses were noted at induction. The substance is not classified as a skin sensitiser.