Registration Dossier
Registration Dossier
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EC number: 216-341-5 | CAS number: 1561-92-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: relatively old study. predating GLP. Yet according to OECD protocol at a renowned lab.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD guideline of 1981-05-12
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Sodium 2-methylprop-2-ene-1-sulphonate
- EC Number:
- 216-341-5
- EC Name:
- Sodium 2-methylprop-2-ene-1-sulphonate
- Cas Number:
- 1561-92-8
- Molecular formula:
- C4H8O3S.Na
- IUPAC Name:
- sodium 2-methylprop-2-ene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Albino, BOR: BHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelman, 4779 Borchen, DE
- Age at study initiation:
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction: intradermal 5%
Induction epicutaneous: 25%
challenge: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: intradermal 5%
Induction epicutaneous: 25%
challenge: 25%
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: not applicable
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: day 1-day 14
- Test groups: 1 (20 females
- Control group:1 (1 females)
- Site: both shoulders
- Frequency of applications: intradermal once, epicutaneous once
- Duration: interdadermal: instantaneous. epicutaneous: 48 hrs
- Concentrations: intradermal 5%, epicutaneous 25%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 day, starting at day 21
- Exposure period: 24 hrs
- Test groups: 1
- Control group: 1
- Site flanks :
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hrs after end-of-challenge
OTHER: - Challenge controls:
- 10 animals, same site, dosage and duration as test animals
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- nothing abnormal noted
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: nothing abnormal noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- nothing abnormal noted
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: nothing abnormal noted.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- nothing abnormal noted
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: nothing abnormal noted.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- nothing abnormal noted
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: nothing abnormal noted.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- sodium methallylsulfonate is not a sensitiser
- Executive summary:
sodium methallylsulfonate was tested for skin sensitising properties in a Magnusson-Kligmann skin sensitisation test. 20 female animals were induced with a 5% concentration intradermally and a 25% concetration epicutaneously, with and without Frund's complete adjuvant. (water and CFA respectively only in 10 controls) . After epicutaneous challenge 14 days after, none of the test animals and none of the controls showed any sign of redness or edema at 24 and 48 hours after challenge. The test substance is not a skin sensitiser.
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