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Toxicological information

Skin sensitisation

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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: Study according to GLP and an OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
Akute Toxizität Sensibilisierung der Haut der Richtlinie 84/449/EWG: Richtlinie der Kommission vom 25. April 1984 zur sechsten Anpassung der Richtlinie 67/548/EWG
Deviations:
yes
Remarks:
number of animals tested
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinylsulfonsaures Natrium, 30 %ig
- Physical state: colorless liquid
- Analytical purity: 30% in aqueous solution
- Impurities (identity and concentrations): Natriumsulfate (0.8%), Natriumhydroxide (0.7%) and Hydroxyethanesulfonic Acid Sodium Salt (2%)
- Lot/batch Date: 18.12.1987
- Storage condition of test material: in the dark at 20°C

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation:
- Weight at study initiation: mean 246 g
- Housing: In air conditioned cages with soft wood granulates, in groups of 5
- Diet (e.g. ad libitum): ERKA-Mischfutter Nr. 8300 ad libitum
- Water (e.g. ad libitum): tap water in plastic drink bottles ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3°C
- Humidity (%): 50 +- 20 %
- Photoperiod (hrs dark / hrs light): 12 : 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: NaCl solution or Freund'schem Adjuvans
Concentration / amount:
5% during the intradermal injections
10% during the dermal induction
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: NaCl solution or Freund'schem Adjuvans
Concentration / amount:
5% during the intradermal injections
10% during the dermal induction
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS: 6 animals were used to determine the non irritating concentration. A concentration of 10 and 1 % were used. 3 animals were used to determine the tolerance of the intradermal injection. Concentrations of 5, 1 and 0,2% were used.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 intradermal injections
- Exposure period:
- Test groups: 10 animals
- Control group: 5 animals
- Site: between head and back

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 48h
- Test groups: 10 animals
- Control group: 5 animals
- Site: same as induction phase
- Evaluation (hr after challenge): evaluation after occlusive challenge during 9 days

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

This test pointed out that no animals showed any positive response for skin sensitization. We can therefor conclude that SVS is not a skin sensitizater.

Applicant's summary and conclusion