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EC number: 479-480-2 | CAS number: 17852-52-7
Skin sensitisation
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:
- other: Test method according to OECD 406. GLP study.
Data source
Reference
- Reference Type:
- other: other: Body responsible for the test.
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 479-480-2
- EC Name:
- -
- Cas Number:
- 17852-52-7
- Molecular formula:
- C6H9N3O2S.ClH
- IUPAC Name:
- 4-hydrazinylbenzene-1-sulfonamide hydrochloride
- Test material form:
- not specified
- Details on test material:
- - Name of test material: 4-hydrazinylbenzenesulfonamide hydrochloride.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Dunkey-Hartley Crl: (HA)BR
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 0.9 % NaCl
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal injections: Substance at concentration of 1 % (g/g) in 0.9 % NaCl.
b) Epidermal application: Substance at concentration of 10 % (g/g) in 0.9 % NaCl.
Concentration of test material and vehicle used for each challenge:
Epidermal application: substance at the concentration of 10 % (g/g) in 0.9 % NaCl.
Challengeopen allclose all
- Route:
- other: Epidermal application.
- Vehicle:
- other: 0.9 % NaCl
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) Intradermal injections: Substance at concentration of 1 % (g/g) in 0.9 % NaCl.
b) Epidermal application: Substance at concentration of 10 % (g/g) in 0.9 % NaCl.
Concentration of test material and vehicle used for each challenge:
Epidermal application: substance at the concentration of 10 % (g/g) in 0.9 % NaCl.
- No. of animals per dose:
- Number of animals in test group: 20
NUmber of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS: Maximum concentration which did not caused irritating effects in preliminary tests: 10 %.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 20 animals.
- Control group: 10 animals.
- Concentration of test material and vehicle used at induction:
a) Intradermal injections: Substance at concentration of 1 % (g/g) in 0.9 % NaCl.
b) Epidermal application: Substance at concentration of 10 % (g/g) in 0.9 % NaCl.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Test groups: 20 animals
- Control group: 10 animals
-Concentration of test material and vehicle used for each challenge:
Epidermal application: Substance at the concentration of 10 % (g/g) in 0.9 % NaCl.
- Evaluation: 2 readings were made, 24 and 48 hours after challenge - Challenge controls:
- no data.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 15
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 15.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 19.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 3.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 10 %
Signs of irritation during induction:
With intradermal injection on day 1 (concentration selected according to the results of the pretests).
With epidermal application of the substance on day 8 (during 48 hours).
Evidence of sensitisation of each challenge concentration:
The substance causes delayed contact hypersensitivity in 15/20 (75 %) of the animals.
Due to the substance, a yellowish discoloration of the treated area of the body was observed in all of the animals from both of the groups. It could have hidden a possible separate or moderate erythema (grade 1 or 2) in some of the animals at the 24-h measurement value. Dryness of the skin was observed in 3/10 of the animals from the control group at the 48-h measurement value. The dryness of the skin is sometimes associated with scabs and/or oedemas. The dryness of the skin was observed in 16/20 of the animals from the treated group at the 48-h measurement value.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions the substance caused delayed contact hypersensitivity in 75 % of the animals.
- Executive summary:
A Guinea Pig Maximisation test was conducted according to OECD guideline 406 and EU method B.6. Dunkey-Harley guinea pigs were induced to develop a hipersensitive state by intradermal injections of 1 % of the test substance in 0.9 % NaCl, with this intradermal injection there were signs of irritation. On day 8 animals were re-induced through an epidermal application of the test substance at 10 % (g/g) in 0.9 % NaCl, there were signs of irritation. The challenge phase of the experiment was performed through an epidermal application of the substance at a concentration of 10 % (g/g) in 0.9 % NaCl. The test substance caused delayed contact hypersensitivity in 15/20 (75%) of the animals.
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