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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22/07/2015-24/07/2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA): BrdU-ELISA

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Sponsor identification: MADERAL ZA1076

Identification of the item tested: PH-15/0488
Date of reception: 08/07/2015
Container: Glass flash x1
Quantity: 118.10g (container + content)
Batch n°: 100026324
Production date: 11/03/2015
Form: liquid
Colour: colourless
Storage: room temperature / darkness
Expiry date: 10/03/2016

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
Suppliers : Elevage Janvier Labs
Animals nullipare, non-pregnant
Randomly allocated to cages
Acclimatation: 5 days
Age at the start of the study: 8 weeks

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
100%, 50%, 25%
No. of animals per dose:
4
Details on study design:
Preliminary screening test (with 100% concentration / one mice):
- No mortality and no signs of systemic toxicity were noted
- Slight dryness was noted on day 6 at the concentration of 100%
- No other cutaneous reactions were noted at the concentration of 100%
- Therefore this concentration was chosen as the highest concentration for the main study
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Positive substance classified in category 1 "skin sensitisation", the control is validate.

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
ca. 1.55
Variability:
0.21
Test group / Remarks:
Concentration: 25%
Key result
Parameter:
SI
Value:
ca. 1.79
Variability:
0.26
Test group / Remarks:
Concentration: 25%
Key result
Parameter:
SI
Value:
ca. 0.77
Variability:
0.18
Test group / Remarks:
Concentration: 25%
Key result
Parameter:
SI
Value:
ca. 1.2
Variability:
0.20
Test group / Remarks:
Concentration: 25%
Key result
Parameter:
SI
Value:
ca. 2.05
Variability:
0.30
Test group / Remarks:
Concentration: 50%
Key result
Parameter:
SI
Value:
ca. 1.47
Variability:
0.44
Test group / Remarks:
Concentration: 50%
Key result
Parameter:
SI
Value:
ca. 1.11
Variability:
0.13
Test group / Remarks:
Concentration: 50%
Key result
Parameter:
SI
Value:
ca. 1.21
Variability:
0.17
Test group / Remarks:
Concentration: 50%
Key result
Parameter:
SI
Value:
ca. 2.38
Variability:
0.26
Test group / Remarks:
Concentration: 100%
Key result
Parameter:
SI
Value:
ca. 1.43
Variability:
0.14
Test group / Remarks:
Concentration: 100%
Key result
Parameter:
SI
Value:
ca. 1.58
Variability:
0.95
Test group / Remarks:
Concentration: 100%
Key result
Parameter:
SI
Value:
ca. 1.03
Variability:
0.11
Test group / Remarks:
Concentration: 100%
Cellular proliferation data / Observations:
A stimulation of more than 1.6 was recorded with the highest tested concentrations.
The SI calculated by individual approach was 1.33, 1.46 and 1.61 for the treated groups at 25%, 50% and 100%, respectively.
EC1.6 was determined : 96.67%
Study positive: SI higher than 1.6 in the greatest group at 100% (SI = 1,61) and a dose-response relationship is noted. However, in accordance with the test guideline, it may be considered as a borderline result.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Executive summary:

The skin sentitzation was performed according to the OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA). The result of the study was positive due to the fact that the SI is higher than 1.6 in the treated group at 100% and a dose-response relationship is noted. However, in accordance with the test guideline, it may be considered as a borderline result (i.e. SI value between 1.6 and 1.9). No cutaneous reaction were noted.