Registration Dossier

Diss Factsheets

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:
1990
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

Constituent 1
Chemical structure
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

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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