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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-09-12 trough 1995-10-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
not specified
Justification for non-LLNA method:
The study was performed before the LLNA method was the first choice method for this endpoint

Test material

Constituent 1
Reference substance name:
Plant preservative product containing silver thiosulfate and other ingredients in an aqueous solution.
IUPAC Name:
Plant preservative product containing silver thiosulfate and other ingredients in an aqueous solution.
Details on test material:
Plant preservative product containing silver thiosulfate and other ingredients in an aqueous solution.

In vivo test system

Test animals

Species:
guinea pig

Study design: in vivo (non-LLNA)

Details on study design:
Ten test and six control albino guinea pigs were used. The intradermal induction of the test substance was applied by 0.1 ml injection of a 10% dilution. The topical induction, one week later, was performed by application of patches loaded with undiluted test substance (test site pretreated with sodium lauryl sulphate) for 48 hours. The challenge treatment (24 hours), 14 days after the last induction, consisted of patches loaded with undiluted test substance as well.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions were observed in test or control animals following the challenge application in the main study after 24 hours.
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions were observed in test or control animals following the challenge application in the main study after 24 hours.
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Range finding for intradermal induction: Three animals were intradermal treated with 100%, 30%, 10% and 3% concentrations of the test substance. Scores were obtained 24 hours after application. Slight to moderate irritation was observed in all concentrations tested. From the 30% concentration upward necrosis was observed as well. No irritation was observed after topical induction with 30% and 100% test substance concentrations in three animals. Challenge: No skin reactions were observed in test or control animals following the challenge application in the main study after 24 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the results obtained it was concluded that, under the conditions of this study and according to the EC-standards silver thiosulphate is not a sensitizer.