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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:
21 May 2020 - 10 August 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Extract from the seeds of Trigonella foenum-graecum (Fabaceae) obtained by extraction with polar solvents
EC Number:
950-727-0
Molecular formula:
Fenugreek extract
IUPAC Name:
Extract from the seeds of Trigonella foenum-graecum (Fabaceae) obtained by extraction with polar solvents
Specific details on test material used for the study:
Identification/Synonym FENUGREEK EXTRACT
Substance type UVCB substance
EC No. 950-727-0
Storage conditions room temperature, protected from light

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Female, nulliparous, non-pregnant, young adult mice (10-11 weeks old)
- 18.9 – 23.8 gTEST ANIMALS
- Females nulliparous and non-pregnant
- 10-11 weeks old
- 18.9 - 23.8 g
- Grouped caging (5 animals)
- Diet: ssniff® Rat/Souris-Elevage E complete
- Water: tap water from watering bottles ad libitum
- Only healthy animals (not showing any sign of skin lesion)

ENVIRONMENTAL CONDITIONS
- Temperature 22 ± 3 °C
- Humidity 30 - 70 %
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Study design: in vivo (LLNA)

Vehicle:
other: Plu
Concentration:
25 %, 10 %, 5 % and 2.5%
No. of animals per dose:
5
Details on study design:
PRE-SCREEN TESTS:
- The test item was applied on the ears of animals as 50 %, 25 %, 10 % or 5 % (w/v) formulations in Plu. The test item was applied on the ears of animals as 50 %, 25 %, 10 % or 5 % (w/v) formulations in Plu.

MAIN STUDY

ANIMAL ASSIGNMENT AND TREATMENT
- Local Lymph Node Assay (Individual Approach)

TREATMENT PREPARATION AND ADMINISTRATION:PRE-SCREEN TESTS:
- Compound solubility: 50 % soluble in aqueous 1 % (w/v) solution
- No negativ reaction

MAIN STUDY

ANIMAL ASSIGNMENT AND TREATMENT
- Local Lymph Node Assay
- Animals showing symptoms of systemic toxicity (significant loss of body weights or other clinical symptoms) or excessive skin irritation (erythema scored as ≥ 3) and those for which a technically failed treatment was observed would have been excluded from the evaluation. In the present study no animal had to be excluded from the evaluation.

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Significant lymphoproliferative response (SI >= 3) was noted for HCA (SI = 13.5). The results of the positive control item demonstrated appropriate performance of the test in accordance with the relevant guidelines and confirmed the validity of the assay.

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.3
Test group / Remarks:
25 % group
Key result
Parameter:
SI
Value:
1
Test group / Remarks:
10 % group
Key result
Parameter:
SI
Value:
1
Test group / Remarks:
5 % group
Key result
Parameter:
SI
Value:
0.8
Test group / Remarks:
2.5 % group
Key result
Parameter:
EC3
Test group / Remarks:
Main study group
Remarks on result:
not determinable
Cellular proliferation data / Observations:
No significant lymphoproliferative response (SI >= 3) compared to the relevant negative control (Plu) was noted at the test concentrations. The corresponding stimulation index values were 1.3, 1.0, 1.0 and 0.8 at test item concentrations of 25 %, 10 %, 5 % and 2.5 % (w/v), respectively.

Based on the results no EC3 value of the test item (dose calculated to induce a stimulation index of 3) is applicable. No further testing is necessary.

No mortality or symptoms of systemic toxicity were observed in any treatment group. No sign of significant irritation was observed.

The mean body weights did not decrease significantly in any test groups

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present assay, the test item analyzed at the maximum attainable non-toxic, non-irritative concentration of 25 % (w/v) and also at concentrations of 10 %, 5 % and 2.5 % (w/v) as formulations (apparently solutions) in a suitable vehicle was shown to have no skin sensitization potential in the Local Lymph Node Assay.