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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
3-Mercaptopropyl-functionalized silica gel
EC Number:
945-952-6
Molecular formula:
Si-CH2-CH2-CH2-SH
IUPAC Name:
3-Mercaptopropyl-functionalized silica gel

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
40% 20% and 10%
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
ca. 0.89
Test group / Remarks:
40%
Key result
Parameter:
SI
Value:
ca. 0.96
Test group / Remarks:
20%
Key result
Parameter:
SI
Value:
ca. 1.14
Test group / Remarks:
10%
Cellular proliferation data / Observations:
CLINICAL OBSERVATIONS:
No mortality and no signs of systemic toxicity were noted in the test and control animals during the test.
Dryness of the skin was noted in all animals treated at 40%, 20% and 10% on day 6.
Residual test item was noted in one animal of the treated group at 10% on day 3.
An increase in ear thickness (+20.4%, +12.5% and+ 18.8%) was noted in animals treated at 10%, 20% and 40%, respectively. No significant increase in ear weight was noted in animals treated at 10%, 20% and 40%. Therefore, the test item has to be considered as not excessively irritant at these concentrations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions, the test item does not have to be classified as a skin sensitizer.