Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Analogue substance tested; GLP study using standard method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Annex V (Maximisation)
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: D. Hall Ltd; Burton on trent, Staffordshire, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 313 - 403 g
- Housing: 1-2 per cage
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: > 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 -21 C
- Humidity (%): 52-66 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal Induction: 10% w/v in deionised water

Topical Induction: 75% w/w in deionised water

Concentration of test material and vehicle used for each challenge:
Topical Challenge : 50% and 25% w/w in deionised water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Intradermal Induction: 10% w/v in deionised water

Topical Induction: 75% w/w in deionised water

Concentration of test material and vehicle used for each challenge:
Topical Challenge : 50% and 25% w/w in deionised water
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
MAIN STUDY
A1. INDUCTION EXPOSURE: intradermal
- No. of exposures: 1
- Exposure period: not applicable
- Control group: vehicle only
- Site: back of the neck/ shoulder
- Concentrations: 10 %

A2. INDUCTION EXPOSURE: epidermal
- No. of exposures: 1
- Exposure period: 48 h occlusive
- Control group: vehicle
- Site: back of the neck/shoulder
- Concentrations: 75 % in water

B. CHALLENGE EXPOSURE: epidermal
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Control group: same as treated
- Site: flank
- Concentrations: 25 % & 50 %
- Evaluation (hr after challenge): 24 h & 48 h
Positive control substance(s):
yes
Remarks:
in separate studies positive results were generated with Mercaptobenzthiazole, hexyl-cinnamic aldehyde, and ethyl-amino-benzoate

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 50 %

Signs of irritation during induction:
Intradermal Induction:
Very slight erythema was noted at all test group sites at the 24 and 48-hour observations. No signs of skin irritation were noted at the control sites at either the 24 or 48-hour observations.

Topical Induction:
Very slight erythema was noted at all test group sites at the 1-hour observation and persisted at one test site at the 24-hour observation. Residual test material was present at all test sites at the 1 and 24-hour observations. Very slight erythema was noted at one control site at the 1-hour observation.

Evidence of sensitisation of each challenge concentration:
None.

Other observations:
Pale yellow coloured staining was noted at all test and control sites at the 24 and 48-hour observations at the 50% w/w dilution and one test and one control site at the 25% w/w dilution.

All animals showed expected gain in bodyweight.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The analogue substance 1 (refer to IUCLID chaper 13) did not cause skin sensitisation in a maximisation test using 50 % as challenge concentration