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Administrative data

Description of key information

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:
04 Jan - 19 Feb 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted February, 1987
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Winkelmann, 4799 Borchen
- Age at study initiation: adult animals
- Weight at study initiation: 358 - 362 g
- Diet (ad libitum): Ssniff G 4 - Alleindiät for guinea pigs, Firma Ssniff, Spezialfutter GmbH, 4770 Soest
- Water (ad libitum): tap water, Fa. Gelsenwasser, Wasserwerk, 4358 Haltern
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1.0% (Induction and Challenge), 10.0% (Preliminary and Induction))
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1.0% (Induction and Challenge), 10.0% (Preliminary and Induction))
No. of animals per dose:
Preliminary study: 4
Main study: 20
Control group for main study: 10
Details on study design:
RANGE FINDING TESTS:
In the preliminary test, a concentration of 10.0% of the test substance in vaseline had no primary irritant effect. Therefore, for the induction phases I, II and III, and for the challenge treatment, the 10.0% test substance concentration in vaseline was initially established. Since, after the first induction inthe main study, skin irritation occurred in eight of 20 test animals, for the following inductions and for the challenge treatment, the test substance concentration was decreased to 1.0%.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Control group: 10 animals (Vehicle treated)
- Site: left flank
- Test groups: 20 animals
- Frequency of applications: single exposure (Induction 1 (day 0) and Inductions 2 (day 7) and 3 (day 14))
- Duration: 0-14 d
- Concentrations: Induction 1: 10.0% Induction 2 and 3: 1.0%

B. CHALLENGE EXPOSURE
- No. of exposures: single exposure
- Day of challenge: day 28
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals (Test substance treated)
- Site: right flank
- Concentrations: 1.0%
- Evaluation (hr after challenge): 6, 24, 48, 72 hours
Challenge controls:
10 control animals were used in the main study.
Positive control substance(s):
not required
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
20 animals displayed no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
20 animals displayed no effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
20 animals displayed no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
20 animals displayed no effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
negative control
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
20 animals displayed no effects
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
1.0%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
20 animals displayed no effects
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1.0%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: 20 animals displayed no effects.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the experimental condition chosen, test substance was assessed as non-sensitising to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The skin sensitisation potential of the test substance was assessed in female guinea pigs using a closed patch test according to Buehler, following OECD guideline 406 and conducted under GLP conditions. The test substance was initially prepared at 10% in Vaseline. In the induction phase, 0.5 mL of the test substance preparation was applied onto the clipped skin of the left flank of 20 animals for 6 h using an occlusive dressing. The control group (10 animals) was treated similarly with the vehicle only. This procedure was repeated twice at weekly intervals. However, due to skin irritation effects, the second and third induction treatments as well as the challenge treatment were performed with the test substance at 1% in Vaseline. Fourteen days after the last induction application, the test substance preparation was applied to the clipped skin of the right flank of all animals for 6 h. Skin reactions were evaluated 6, 24, 48 and 72 h after the challenge application.

Twenty-four hours after the first induction treatment, signs of irritation were observed in 8/10 test animals in the form of very slight to moderate erythema and very slight edema, generally as localized skin reactions. No skin reactions were observed after the second and third induction treatments. Control group animals exhibited no signs of skin irritation.

The challenge treatment, immediately after patch removal, and after 24, 48, 72 hours, did not lead to signs of skin irritation in test or control group animals. No other treatment-related effects were observed. The maximum percentage of animals sensitised was 0 %. Animals of both groups survived throughout the test period. No signs of toxicity were recorded (Study director 1993c).

Further data available on the test substance is limited to a not reliable study, in which guinea pigs were induced by a total of 10 intradermal applications of the test substance at 0.5% in water, 3 times weekly for 3 weeks. Two weeks after the induction phase, test and control animals were challenged by a single intradermal application of the test substance at 0.1% in water. Skin reactions were evaluated 24 h thereafter. Skin reactions (not specified) were observed in 4/8 test animals and in all 8 animals of the control group (CHIMOSA 1979).


Migrated from Short description of key information:
The test substance is not a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
The most criticial valid study data was selected.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation is conclusive but not sufficient for classification according to DSD (67/548/EEC) and GHS (CLP, 1272/2008/EC).

There is no data available on the respiratory sensitisation potential. Thus, classification is not possible due to data lacking.