Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6th Nov 1996 - 29 November 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (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:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Charles River France
- Age at study initiation: 7 weeks old
- Weight at study initiation: 450 g+-100 g
- Housing:wire mesh bottom stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):free access to tap water
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20+-2C
- Humidity (%): 45-75
- Air changes (per hr):10-12
- Photoperiod (hrs dark / hrs light):12/24

IN-LIFE DATES: From:november 6 To:November 29

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Concentration of test material and vehicle used at induction: 6 animals - right flank 40%, left flank -20% and then 6 animals 5% right flank and 10% left flank . The concnetration retained for the final assay was 10% w/v

Topical application: 50% w/w in arachis oil BP

Concentration of test material and vehicle used for each challenge:
50% and 25% w/w in arachis oil BP
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Concentration of test material and vehicle used at induction: 6 animals - right flank 40%, left flank -20% and then 6 animals 5% right flank and 10% left flank . The concnetration retained for the final assay was 10% w/v

Topical application: 50% w/w in arachis oil BP

Concentration of test material and vehicle used for each challenge:
50% and 25% w/w in arachis oil BP
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 - intadermal and occlusive
- Exposure period: 8 days
- Test groups: 20 males
- Control group: 20 males
- Site: intradermal injections 0.1 ml (10%) at D1, occlusive bandage (48hr) 0.9 ml (40%) at D8
- Frequency of applications:
- Duration: 48 hr
- Concentrations:0.1 ml (10%) at D1; 0.9 ml (40%) at D8

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: D21
- Exposure period:24hr occlusive bandage
- Test groups: 20
- Control group:20
- Site:left flank control; right flank test substance
- Concentrations:0.2 ml of 10%
- Evaluation (hr after challenge):24 and 48 hr after treatment- local reaction (erythema, edema)

OTHER:
Challenge controls:
20 males with vehicle only
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: induction phase
Group:
test group
Dose level:
10% and 40%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no cutaneous reaction
Remarks on result:
other: Reading:
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
slight erythema that cleared up at 48 hours
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight erythema that cleared up at 48 hours.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
slight erthyema that cleared up at 48 hours
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: slight erthyema that cleared up at 48 hours.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 10 %



Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance has no cutaneous sensitizing activity in guines pigs.