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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
other: HJ/T 153 Appendix 406 Skin Sensitisation Test
Version / remarks:
2004
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The In vivo data was necessary to generate as it is a requirement for performing a substance registration in China under MEP Order 7.

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium Nickel Manganese Magnesium Titanium Dioxide (Crystal phase: O3/P2/RS)
EC Number:
951-477-5
Molecular formula:
Na1-δNivMnwMgxTiyO2, where the ranges are 0 < δ < 0.2, 0.2 < v < 0.4, 0.4 < w < 0.6, 0.02 < x < 0.2, 0.02 < y < 0.2
IUPAC Name:
Sodium Nickel Manganese Magnesium Titanium Dioxide (Crystal phase: O3/P2/RS)
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.2 mL solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
There were no abnormal general findings in the control and treated guinea pigs in test.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0.2 mL solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
There were no abnormal general findings in the control and treated guinea pigs in test.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.2 mL 3% test solution
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
There were no abnormal general findings in the control and treated guinea pigs in test.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.2 mL 3% test solution
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
There were no abnormal general findings in the control and treated guinea pigs in test.
Key result
Group:
positive control
Dose level:
0.2 mL 2.5% test solution of 2-mercaptobenzothiazole
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The sensitisation incidence of the control group is 0%, and the sensitisation incidence of the treated group is 5%. Therefore, under this test condition, based on these findings and the evaluation system used, TBM-141 is feeble sensitizer.
Executive summary:

Introduction: The skin sensitisation potential of TBM-141 was determined in guinea pigs following repeated dermal application using the Buehler Method in this study. The study was conducted in compliance with the requirements of “the Guidelines for the Testing of Chemicals-Health Effects” (the second edition).


Method: 0.2 mL 6% test solution was used in induction, and 0.2 mL 3% test solution was used in challenge. 0.2 mL 6% test solution was applied to the shaved left flank every treated guinea pigs (20 animals) once per week during the induction period of three consecutive weeks. The control guinea pigs (10 animals) were handled in same manner, but were not treated with the test chemical in induction. About two weeks following the third induction exposure, 0.2 mL 3% test solution was applied to the shaved right flank of the treated and the control guinea pigs in challenge. Following each induction, the skin reactions were observed and recorded for erythema and edema about 1, 24 and 48 hours after removal of wrappings. Following challenge, the skin reactions were observed and recorded for erythema and edema about 24 and 48 hours after removal of wrappings.


Results: Following induction, there were no visible changes of the control animals, Seventeen animals of the treated group were found slight erythema on test area. Following challenge, there were no visible changes of the control animals, one animals (animal ID: 2716) of the treated group were found discrete erythema on test area, and the other nineteen animals of the treated animals were no visible changes. The sensitisation incidence is 5%.


Conclusion: Under this test condition, based on these findings and the evaluation system used, the sensitisation incidence of TBM-141 is 5%. According to “the Guidelines for the Testing of Chemicals-Health Effects” (the second edition), TBM-141 is feeble sensitizer.