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:
supporting study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study. It was not specified whether the study was conducted in accordance with GLP or not.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo; Ani Labo; Gwen Meur; Shamrock Farms
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 300 to 500 g
- Housing: in groups of 5 (gender separated) in polystyrene cages
- Diet: 50 g per animal per day (granules cobaye Extra Labo)
- Water: softened and filtered water, ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 times per hour (pre-filtered air: 5-10 µL)
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction:
intradermal - 0.05 % (v/v), occlusive topical - 10 % (v/v)
Challenge:
occlusive topical - 2.5 % (v/v)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction:
intradermal - 0.05 % (v/v), occlusive topical - 10 % (v/v)
Challenge:
occlusive topical - 2.5 % (v/v)
No. of animals per dose:
10 (controls), 20 (test groups)
Details on study design:
PRE-STUDY:
Following test substance concentrations were determined within a üre-study:
- The concentration at which the test substance provokes a weak to moderate irritation by intradermal route and by topical application under occlusive patch-test for 48 hours on a cutanous area of 8 cm2.
- The concentration at which this test substance produces no pathological cutaneousreaction by topical application under occlusive patch-test for 24 hours an a surface of 4 cm2.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: single injection (intradermal), 48 hours (epicutaneous)
- Test groups:
Intradermal - 2x 0.1 mL injections; 1) test substance (0.05 % (v/v)) diluted in liquid paraffin; 2) 50/50 (v/v) mixing of test substance (0.1 % (v/v)) in liquid paraffin with Freund complete adjuvant (at 50 % (v/v))
Epicutaneous: 10% test substance in vehicle (liquid paraffin)
- Control group:
Intradermal - 2x 0.1 mL injections; 1) liquid paraffin; 2) 50/50 (v/v) mixing of liquid paraffin with Freund complete adjuvant (at 50 % (v/v))
Epicutaneous: vehicle (liquid paraffin)
- Site: scapular region on each side of the spine
- Frequency of applications: once
- Duration: 0-7 days
- Concentrations: intradermal 0.05 %, epicutaneous, 10 %

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 21
- Exposure period: 24 hours
- Test groups/control group: test substance in vehicle
- Site: on the left and right flanks, a region that has never been treated before
- Concentrations: 2.5 %
- Evaluation (hr after challenge): 1, 6, 24 and 48 hours
- The intensity of erythematous and oedematous reactions is scored according to the following scale :
No reaction-0
Slight erythema (hardly visible)-1
Moderate erythema (well visible)-2
Severe erythema with oedema-3
Any other anomalies are also noted, e.g. vesicles, thickening or skin dryness.
- skin samples for histopathological evaluation were taken from animals with scores 1-3.
Positive control substance(s):
yes
Remarks:
data obtained in the testing facilities in 1982 with reference substances, were listed as appendix in the study report.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
2.5 %
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
signs of allergy
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5 %. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: signs of allergy.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: Category 1A
DSD: R43