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Diss Factsheets

Administrative data

Description of key information

The key study provided was conducted to recognised testing guidelines and with GLP certification.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
modified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study predates the LLNA test guideline (OECD 429). The study is rated reliability 1 (Klimisch et al, 1997), and was conducted to GLP standards. Reproducing this endpoint using the LLNA test guideline is considered to be scientifically not necessary.
Species:
guinea pig
Strain:
other: Pirbright (Tif: DHP) White strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: ca. 10 weeks old
- Weight at study initiation: 323 - 446 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum standard guinea pig pellets - NAFAG No. 846, Gossau SG
- Water (e.g. ad libitum): ad libitum fresh water, supplemented with fresh carrots.
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Induction: 10 % in vaseline ; ca. 0.4 g per patch
Challenge: 10 % in vaseline; ca. 0.2 g per patch
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
Induction: 10 % in vaseline ; ca. 0.4 g per patch
Challenge: 10 % in vaseline; ca. 0.2 g per patch
No. of animals per dose:
10 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: First induction week = 24 hours; Second induction week = 48 hours
- Site: 4 sites on the animal's neck.
- Frequency of applications: once per week
- Concentrations: First induction week = 0.1 ml of a freshly prepared adjuvant saline mixture; Second induction week = 10 % test compound in vaseline; ca. 0.4 g per patch
- Control group: treated with adjuvant and the vehicle during the induction period

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours
- Site: untreated contralateral flanks of the animals
- Concentrations: 10 % test compound in vaseline; ca. 0.2 g per patch
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
During the challenge period the group was treated with the vehicle as well as with the test compound to control the maximal sub irritant concentration of the test compound in adjuvant treated animals.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
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: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Induction: negative control (vehicle), Challenge: test compound
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Induction: negative control (vehicle), Challenge: test compound. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: Induction: test compound; Challenge: negative control (vehicle)
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Induction: test compound; Challenge: negative control (vehicle). Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
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: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Induction: negative control (vehicle); Challenge: test compound
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Induction: negative control (vehicle); Challenge: test compound. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: Induction: test compound; Challenge: negative control (vehicle)
Dose level:
0 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Induction: test compound; Challenge: negative control (vehicle). Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material failed to induce sufficent skin sensitisation to be considered a skin sensitiser.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The potential of the test substance to induce delayed contact hypersensitivity was assessed using a modified Guinea Pig Maximisation Test (GPMT) in a GLP conform study according to OECD guideline 406. Groups of 10 male and female Pirbright White Strain guinea pigs were treated with 10 % w/w of the test substance in vaseline or with the vehicle alone in the induction phase and in the challenge phase of the study. At the concentration of 10% in vaseline, no induction of edema or erythema reactions were seen after epidermal challenge application. Twenty four hours after removing the occlusive dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. The sensitising potential of the test substance was classified to the lowest sensitization class according to the grading of Magnusson and Kligman.

Under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. The test item is therefore not considered to be irritating.


Migrated from Short description of key information:
To evaluate the allergic potential of the test substance, a skin maximisation test (OECD 406, GLP) in ten test and five control guinea-pig was perfomed. The substance did not induce any dermal reactions in test animals. Thus, the test substance is considered to be as non-sensitizing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.