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Diss Factsheets

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:
From 27 March, 2000 to 4 April 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The purpose of this study was to evaluate whether the test substance induces contact hypersensitivity in guinea pigs after intradermal and epidermal exposure of the animals under the conditions described in this study. This study should provide a rational basis for risk assessment in man. The Maximisation test is selected because it is regarded as the most sensitive and the preferred method with regard to testing for sensitisation potential.

Test material

Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kissle99. Germany.
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified]
- Age at study initiation: 7 weeks old
- Weight at study initiation: 485 - 530 g
- Housing: Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped
with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid (1000 mg/kg); (Charles River Breeding and Maintenance Diet for Guinea Pigs, Altromin, Lage, Germany).
- Water (e.g. ad libitum): Free access to tap water, ad libitum.
- Acclimation period: The acclimatisation period was at least 5 days before the start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermique: 0.2 %

Epidermique: 50 %

Eau

Concentration of test material and vehicle used for each challenge:
Epidermique: 50 %

Eau
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
Intradermique: 0.2 %

Epidermique: 50 %

Eau

Concentration of test material and vehicle used for each challenge:
Epidermique: 50 %

Eau
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TESTS:
Intradermal injections:
- No. of exposures: 2 injection in duplicate
- Exposure period: day 0
- Test groups: 4 animals
- Site: scapular region
- Frequency of applications: duplicate
- Concentrations: (0.1 ml/site)
Animal: concentration:
73 20 %, 10 %,
74 5 %, 2%,
93 1 %, 0.5 %
94 0.2 %, 0.1 %

Epidermal appliation
- No. of exposures: 2 application
- Day(s) of challenge: 0
- Test groups: 4 animals
- Site: clipped flank
- Concentrations: 0.5 ml
- Evaluation (hr after challenge): 24 and 48 hours after exposure.
Animal: concentration:
71 50 %, 20 %,
72 50 %, 20 %,
73 10 %, 5 %
74 10 %, 5 %

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Frequency of applications:
- Duration:
- Concentrations:

B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations:
- Evaluation (hr after challenge):

OTHER:

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
10
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: 10.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
10
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: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0 %
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: 0 %. 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:
1
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: 1.0. Total no. in groups: 5.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
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: 0 %. 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:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
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: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
1st reading
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
other: skin sens. 1B
Conclusions:
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), the substance should be labelled as: may cause sensitisation by skin contact (skin sens. 1B).
Executive summary:

The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation" and OECD No. 406, "Skin Sensitisation", and based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - identification of Contact Allergens".

Test substance concentrations selected for the main study were based on the results of a preliminary study.

ln the main study, ten experimental animals were intradermally injected with a 0.2% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with vehicle alone (water). Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS.

Two weeks alter the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle.

in the challenge phase, skin reactions varying between grades 1 and 3, were observed in all experimental animals in response to the 50% test substance concentration. ln one control animal, a skin reaction of grade 1 was observed, 24 hours after challenge only. Scaliness and eschar formation were seen in some treated skin sites among the experimental animals.

Blue staining was observed at all test substance treated skin sites, 24 and 48 hours after challenge. This staining did not hamper the scoring of the skin reactions. Taking into account the intensity and duration of the responses and comparing these with the

skin reactions seen in the control animals, it was considered that hypersensitivity to the substance had been induced in the experimental animals. The skin reaction, as observed in one control animal, was considered to be a sign of non-specific irritation.

These results indicate a sensitisation rate of 100 per cent.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), the substance should be labelled as: may cause sensitisation by skin contact (skin sens. 1B).