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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Soybean meal
EC Number:
269-648-1
EC Name:
Soybean meal
Cas Number:
68308-36-1
IUPAC Name:
Soybean meal

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
0.5%, 1.25%, 2.5%, 5%
No. of animals per dose:
4 female mice per dose
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The positive control material gave a SI of 4.62 and 2.29 in Experiments 1 and 2, respectively.
Although there are no acceptance criteria for a valid study, it would be expected that the positive control would produce a SI of ≥3. The result from Experiment 2 was just below this value, but was sufficiently close to the range observed at these laboratories from 2016 to 2017 (2.69 to 17.27) to be considered acceptable.

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.04
Test group / Remarks:
0.5%
Key result
Parameter:
SI
Value:
1.53
Test group / Remarks:
1.25%
Key result
Parameter:
SI
Value:
1.53
Test group / Remarks:
2.5%
Key result
Parameter:
SI
Value:
0.7
Test group / Remarks:
5%
Cellular proliferation data / Observations:
All animals survived treatment with Soybean Meal (CAS 68308-36-1).
There were no clinical signs indicative of a systemic effect of treatment among mice treated with the vehicle or with 0.5, 1.25, 2.5 or 5% w/v formulations of the test
article.
There was no indication of a treatment related effect on body weight.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Due to the lack of dose dependency (no effects at lower concentrations in first experiment), it was considered that there was a low probability for a false negative result and the result for the positive control in Experiment 2, did not impact on the outcome or conclusion of the study.
The Local Lymph Node Assay demonstrated that Soybean Meal (CAS 68308-36-1) does not have the potential to cause skin sensitisation, under the conditions of this study.

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