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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
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:
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Induction: intradermal 5%
Induction epicutaneous: 25%
challenge: 25%
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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
0/20 test animals and 0/10 controls showed signs of redness or edema . Not a sensitiser

Justification for selection of skin sensitisation endpoint:
OECD protocol study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

key study shows that the substance is not a skin sensitiser in a maximisation test. Therefore it must not be classified

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