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EC number: 217-157-8 | CAS number: 1758-73-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- analytical purity not reported
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- Aminoiminomethanesulphinic acid
- EC Number:
- 217-157-8
- EC Name:
- Aminoiminomethanesulphinic acid
- Cas Number:
- 1758-73-2
- Molecular formula:
- CH4N2O2S
- IUPAC Name:
- aminoiminomethanesulphinic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: about 10 weeks
- Weight at study initiation: 306- 437 g (male, female)
- Housing: individually in Macrolon cages (Type III)
- Diet: standard guinea pig pellets, ad libitum
- Water: fresh water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 30-70
- Air changes (per hr): 12/12
- Photoperiod (hrs dark / hrs light):
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Vaseline (white petroleum)
- Concentration / amount:
- Induction: 1% (intradermal) + 30% (epicutaneous)
Challenge: 3%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline (white petroleum)
- Concentration / amount:
- Induction: 1% (intradermal) + 30% (epicutaneous)
Challenge: 3%
- No. of animals per dose:
- 10 (controls), 20 (in test groups)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injections (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) adjuvant/saline
Injection 2: test substance in physiological saline
Injection 3: test substance in a 1:1 mixture (v/v) adjuvant/saline
- Control group:
Intradermal (1 pairs of injection):
Injection 1: aa 1:1 mixture (v/v) adjuvant/saline
- Site: shaved neck
Epicutaneous
-Site: Example: shoulder region (intradermal + epicutaneous)
- Frequency of applications: Example: every 7 days
- Duration: Example: Days 0-8
- Concentrations: Example: intradermal 1%, epicutaneous 30%
- Frequency of applications: once a week
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: flank
- Concentrations: 3%
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- yes
- Remarks:
- p-phenylenediammine / potassiumdichromate
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% (induction), 3% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% (induction), 3% (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% (inductionl) , 3% (challemge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% (inductionl) , 3% (challemge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1% (induction) , 3% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1% (induction) , 3% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1% (induction), 3% (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1% (induction), 3% (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
RESULTS
The incidence of positive animals per group and the individual challenge reactions are listed in Table 1, 2 and 3.
The individual animal weights at start and end of the test are listed in Table 4.
Under the experimental conditions employed, 0% of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings.
Table 1: Number of animals per group after occlusive epicutaneous application
Group |
|
After 24 hours |
After 48 hours |
Control group |
Vehicle control |
0 / 20 |
0 / 20 |
|
Test compound |
0 / 10 |
0 / 10 |
Test group |
Vehicle control |
0 / 20 |
0 / 20 |
|
Test compound |
0 / 20 |
0 / 20 |
Table 2: Challenge reactions after epicutaneous administration (CONTROL GROUP)
DRAIZE SCORE 24 hours after removal of the dressing: |
||||||||||
Vehicle control |
||||||||||
Male animals |
341 |
342 |
344 |
344 |
345 |
346 |
348 |
348 |
349 |
350 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
||||||||||
Female animals |
351 |
352 |
353 |
354 |
355 |
356 |
357 |
358 |
359 |
360 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Test compound control |
||||||||||
Female animals |
351 |
352 |
353 |
354 |
355 |
356 |
357 |
358 |
359 |
360 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
DRAIZE SCORE 48 hours after removal of the dressing: |
||||||||||
Vehicle control |
||||||||||
Male animals |
341 |
342 |
344 |
344 |
345 |
346 |
348 |
348 |
349 |
350 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
||||||||||
Female animals |
351 |
352 |
353 |
354 |
355 |
356 |
357 |
358 |
359 |
360 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Test compound control |
||||||||||
Female animals |
351 |
352 |
353 |
354 |
355 |
356 |
357 |
358 |
359 |
360 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 3: Challenge reactions after epicutaneous administration (TEST GROUP)
DRAIZE SCORE 24 hours after removal of the dressing: |
||||||||||
Vehicle control |
||||||||||
Male animals |
321 |
322 |
323 |
324 |
325 |
326 |
327 |
328 |
329 |
330 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
||||||||||
Female animals |
331 |
332 |
333 |
334 |
335 |
336 |
337 |
338 |
339 |
340 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Test compound |
||||||||||
Male animals |
321 |
322 |
323 |
324 |
325 |
326 |
327 |
328 |
329 |
330 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
||||||||||
Female animals |
331 |
332 |
333 |
334 |
335 |
336 |
337 |
338 |
339 |
340 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
DRAIZE SCORE 48 hours after removal of the dressing: |
||||||||||
Vehicle control |
||||||||||
Male animals |
321 |
322 |
323 |
324 |
325 |
326 |
327 |
328 |
329 |
330 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
||||||||||
Female animals |
331 |
332 |
333 |
334 |
335 |
336 |
337 |
338 |
339 |
340 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Test compound |
||||||||||
Male animals |
321 |
322 |
323 |
324 |
325 |
326 |
327 |
328 |
329 |
330 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
||||||||||
Female animals |
331 |
332 |
333 |
334 |
335 |
336 |
337 |
338 |
339 |
340 |
Erythema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Edema score: |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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