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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:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: 4 w
- Weight at study initiation: 256 - 295 g
- Housing: groups of 2 or individually
- Environmental enrichment: tunnel
- Diet (ad libitum): SDS – FD1 guinea pig breeding and maintenance diet
- Water (ad libitum): tap water
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): ca. 15
- Photoperiod (light): 7:00 - 19:00
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
The test substance was prepared in isotonic saline for the intradermic injections and in distilled water for the topical applications. At 50 % a homogeneous white paste was obtained.
Intradermal induction, applying to 2 injections of 0.1 mL each of:
- Freund's Complete Adjuvant diluted by 50 % in isotonic NaCl
- test substance at 3.125 % in isotonic NaCl
- a mixture 1 + 1 v/v of Freund's Complete Adjuvant at 50 % and test substance at 6.25 % in isotonic NaCl
For the negative control the test substance was replaced by isotonic NaCl
Topical induction:
0.5 mL of the test substance diluted at 50 %.
For the negative control: distilled water.
Challenge exposure:
50 % and 25 % test substance for both groups.
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
The test substance was prepared in isotonic saline for the intradermic injections and in distilled water for the topical applications. At 50 % a homogeneous white paste was obtained.
Intradermal induction, applying to 2 injections of 0.1 mL each of:
- Freund's Complete Adjuvant diluted by 50 % in isotonic NaCl
- test substance at 3.125 % in isotonic NaCl
- a mixture 1 + 1 v/v of Freund's Complete Adjuvant at 50 % and test substance at 6.25 % in isotonic NaCl
For the negative control the test substance was replaced by isotonic NaCl
Topical induction:
0.5 mL of the test substance diluted at 50 %.
For the negative control: distilled water.
Challenge exposure:
50 % and 25 % test substance for both groups.
No. of animals per dose:
5 in the negative control group + 10 in the test substance group
Details on study design:
The animals were carefully shorn before each item application:
- on the inter-scapular zone for the induction phase.
- on the dorso-lumbar zone for the challenge phase.
At least 3 hours before the first reading (challenge phase) they were shorn a second time in this dorsolumbar zone.
The animals were weighed at the beginning and at the end of the main test.

RANGE FINDING TESTS:
For the results: see the attachment.
To determine the maximal non-necrotizing concentration after intradermal injection: No necrosis was observed at 3.125 %.
To determine the pre-maximal non-irritant concentration after topical application: No cutaneous reaction, except for depilation in one animal, was observed at 50 %.
To determine the maximal non-irritant concentration after topical application: No cutaneous reaction was observed at 50 %.

MAIN STUDY
A. INDUCTION EXPOSURE
1st Intradermal Induction on Day 0. After shearing the scapular zone, three pairs of intradermal injections (ID) of 0.1 mL were performed on the scapular zone in such a way as an injection on each pair is placed to either side of the spine.
2nd Topical induction on Day 6 the scapular zone of all the animals in each group, shorn beforehand, was brushed with 0.5 mL of a
solution of sodium lauryl sulfate at 10 % in thick vaseline, in order to create a local irritation. On Day 7 a topical application under occlusive dressing for 48 hours was performed on the injection sites of each animal. Day 9: Removal of the occlusive dressing.

B. CHALLENGE EXPOSURE
Day 20: The experimental procedure of this phase is identical for both groups (Negative control and (Treated). On the previously shorn dorso-lumbar zone, an application on either side of the spine, under occlusive dressing, is performed during 24 hours:
- 1 sample cup containing the test item diluted at 50 % and 1 sample cup containing the test item at 25 %. Day 21: Removal of the occlusive dressing.
Positive control results:
Historical positive control data with hexylcinnamaldehyde are presented in the report.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No abnormalities..
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Depilation was noted 3/5 animals. Otherwise: no abnormalities.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Depilation was noted 3/5 animals. Otherwise: no abnormalities..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No abnormalities..
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
Depilation was noted 3/5 animals. Otherwise: no abnormalities.
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. Clinical observations: Depilation was noted 3/5 animals. Otherwise: no abnormalities..
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities.
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No abnormalities..
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
Slight erythema in 1/10 animals. Dryness of the skin of 1/10 animals, otherwise no abnormalities.
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 %. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Slight erythema in 1/10 animals. Dryness of the skin of 1/10 animals, otherwise no abnormalities..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No abnormalities..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Dryness of the skin of 1/10 animals, otherwise no abnormalities.
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Dryness of the skin of 1/10 animals, otherwise no abnormalities..

The mean and the summary results are presented in the attachment.

No cutaneous reaction was recorded after the first induction. During the second induction, dryness was noted in 8/10 treated and 3/5 control animals and scab was noted in 1/5 control animals, 24 h after the removal of the dressing.

The body weight development was inconspicuous. No mortality was noted.

Historical positive control data with hexylcinnamaldehyde are presented in the report.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not considered to be a sensitiser.
Executive summary:

A possible allergic activity of the test substance was investigated in the Guinea Pig Maximisation Test. A slight erythema was noted in 1/10 treated animals at 50 % test substance concentration in water, but not at 25 %. No other cutaneous reactions were recorded in the treated and the negative control groups at the challenge exposure. The test substance is not considered to be a sensitiser.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Justification for selection of skin sensitisation endpoint:
Key study.

Justification for classification or non-classification

There is no justification which would justify a classification.