Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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: LAB-ÁLL Bt. Budapest, Hungary
- Weight at study initiation: 362-434 g
- Housing: 2-3 animals in 42x42x19 cm macrolon cages
- Diet (e.g. ad libitum): ad libitum, PUNIPLUS standard diet for rabbits (AGRIBRAND)
- Water (e.g. ad libitum): ad libitum, potable water containing 50 mg/100 ml Ascorbic acid.
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Rate of air exchange: 13-17/hour
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: methylcellulose (1%)
Concentration / amount:
75 (w/v) % in methylcellulose 1 % aqueous solution for dermal induction treatment and for the challenge treatment,
0.1 % for the intradermal treatment using Freund's complete adjuvant and physiological saline.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: methylcellulose (1%)
Concentration / amount:
75 (w/v) % in methylcellulose 1 % aqueous solution for dermal induction treatment and for the challenge treatment,
0.1 % for the intradermal treatment using Freund's complete adjuvant and physiological saline.
No. of animals per dose:
In the range finding study: 2 animals / 2 concentrations (2 concentrations in 1 animal: one on the right side and the other on the left side)
Main study: test groups - 10 animals
control group - 5 animals
Details on study design:
10 test animals were subjected to sensitization procedures in a two stage operation, i.e. intradermal treatment and a topical application.
The test item was used in concentration of 0.1% for intradermal injections and in concentration of 75 % (w/v) for dermal sensitization treatment. Before Before the dermal exposure the test area was painted with 0.5 ml of 10% sodium lauryl sulphate in vaseline 24 h prior to the topical induction application, in order to create a local irritation.
Two weeks following the last induction exposure, a challenge dose (in concentration 75%) was administered. Challenge was performed by dermal application of the test item.
Challenge controls:
5 control guinea pigs were simultaneously exposed to vehicle during the sensitization phase and they were treated with the test item (in concentration 75 %) only in the case of challenge.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
75 w/v %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 w/v %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
75 w/v %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 w/v %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no visible change.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75 w/v %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 w/v %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75 w/v %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 w/v %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no visible change.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information EU
Conclusions:
According to net percentage value of positively responded animals and to the net score value of the skin reactions, the test item
was classified as no sensitizer.