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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
No data.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted prior to the establishment of standardised guidelines.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
For the initial induction, guinea pigs were administered hydroxylammonium sulphate (5%, in water) via intradermal injection. At day 7, animals were administered a topical induction of 25% of the test substance in water followed by a challenge treatment of 10% of the test substance in water at dat 21. At day 55, rechallenge was conducted.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity > 98%

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Induction
Intradermal injection: 5% concentration of hydroxylammonium sulphate in water
Topical induction: 25% of hydroxylamonium sulphate in water

Challenge
10% hydroxylammonium sulphate
Challengeopen allclose all
Route:
other: Epicutaneous (occlusivity not stated)
Vehicle:
water
Concentration / amount:
Induction
Intradermal injection: 5% concentration of hydroxylammonium sulphate in water
Topical induction: 25% of hydroxylamonium sulphate in water

Challenge
10% hydroxylammonium sulphate
No. of animals per dose:
24 animals
Details on study design:
For the initial induction, guinea pigs were administered hydroxylammonium sulphate (5%, in water) via intradermal injection. At day 7, animals were administered a topical induction of 25% of the test substance in water followed by a challenge treatment of 10% of the test substance in water at dat 21. At day 55, rechallenge was conducted.
Challenge controls:
Control animals were administered only vehicle during the intradermal and topical induction. At the challenge, 10% of the test substance in water was administered.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test group
Dose level:
10%
No. with + reactions:
22
Total no. in group:
24
Clinical observations:
moderate to intense redness and swelling
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 10%. No with. + reactions: 22.0. Total no. in groups: 24.0. Clinical observations: moderate to intense redness and swelling.
Reading:
2nd reading
Hours after challenge:
55
Group:
test group
Dose level:
10%
No. with + reactions:
22
Total no. in group:
24
Clinical observations:
moderate to intense redness and swelling
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 55.0. Group: test group. Dose level: 10%. No with. + reactions: 22.0. Total no. in groups: 24.0. Clinical observations: moderate to intense redness and swelling.
Reading:
1st reading
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
24
Clinical observations:
No dermal reactions were observed
Remarks on result:
other: Reading: 1st reading. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 24.0. Clinical observations: No dermal reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Bis(hydroxylammonium)sulphate was shown to cause sensitisation reactions in guinea pigs.
Executive summary:

In Magnusson Kligman Test, similar to OECD Guideline 406, bis(hydroxylammonium)sulphate was administered to guinea pigs via intradermal injection on day 1 and topical application on day 7 as part of the induction period. Animals were challenged with the chemical on days 21 and 55 which caused sensitisation in 96% of the animals. Dermal reactions were classified into grade 2/3 (moderate to intense redness and swelling). By this study design in guinea pigs bis(hyroxylammonium)sulphate is considered to be a sensitising agent. This study is considered to be reliable with restrictions as the study was conducted prior to the establishment of standardised guidelines.