Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-02-23 to 1988-03-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented and reliable guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
guinea pig maximisation test
Deviations:
yes
Remarks:
(concentration at epicutaneous induction too low because the selected concentration induced no mild-to-moderate skin irritation; there was no treatment on day 8 to create a local irritation.)
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material: Sodium ethylenesulphonate (Sodium vinylsulphonate)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-breed, Germany
- Weight at study initiation: 204g - 286 g
- Housing: groups of five animals each
- ERKA feed Number 8300 for guinea pigs and rabbits
- Diet: ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least five days

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Please refer to details on study design (Traditional test)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Please refer to details on study design (Traditional test)
No. of animals per dose:
Pretest:
6 animals for the determination of the non-irritating concentration
3 animals for the determination of the intradermal tolerance
5 animals satellite group
5 animals control group
10 animals treated goup
Details on study design:
RANGE FINDING TESTS:

A. Determination of the non-irritating concentration
0.5 mL on the right and left flank, occlusive, exposure time: 24h

- undiluted solution (30 % Sodium ethylensulphonate)
- 10% test solution in 0.9 % NaCl (3 % Sodium ethylensulphonate)
- 1% test item in 0.9 % NaCl (0.3 % Sodium ethylensulphonate)

At the end of the exposure period the skin of the animals was observed for eythema and oedema formation. Signs of skin irritation were scored according to the Draize scoring system.

B. Determination of the intradermal tolerance
Intradermal injection on the back of the animals (3 areas per animal, 2 injections per area)

1. area: 2x0.1 ml 5% test solution in 0.9 % NaCl (1.5 % Sodium ethylensulphonate)
2. area: 2x0.1 ml 1% test solution in 0.9 % NaCl (0.3 % Sodium ethylensulphonate)
3. area: 2x0.1 ml 0.2% test solution in 0.9 % NaCl (0.06 % Sodium ethylensulphonate)

MAIN STUDY

A. Intradermal induction (day 1)
Intradermal injection on the back of the animals (3 areas, 2 injections per area)

1. area: 2x0.1 mL 50 % Freund´s Adjuvant
2. aerea: 2x0.1 mL 5 % test solution in 0.9 % NaCl (1.5 % Sodium ethylensulphonate)
3. aerea: 2x0.1 mL 5 % test item in Freund´s Adjuvant (1.5 % Sodium ethylensulphonate)

B. Dermal induction (day 9)
0.5 mL on the intradermal injection area (back), occlusive, exposure time: 48h

Treated group: 10 % test solution in 0. 9% NaCl (3 % Sodium ethylensulphonate)
Control/satellite group: 0.9 % NaCl

C. CHALLENGE EXPOSURE (day 22)
0.5 mL on the left flank, occlusive, exposure time: 24h

Treated group and control group: 10 % test solution in 0.9 % NaCl (3 % Sodium ethylensulphonate)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10 % test solution in 0.9 % NaCl (3 % Sodium ethylenesulphonate)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical signs were observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % test solution in 0.9 % NaCl (3 % Sodium ethylenesulphonate). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical signs were observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10 % test item in 0.9 % NaCl (3 % Sodium ethylenesulphonate)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical signs were observed
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % test item in 0.9 % NaCl (3 % Sodium ethylenesulphonate). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical signs were observed.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control
Dose level:
10 % test item in 0.9 % NaCl (3 % Sodium ethylenesulphonate)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clinical signs were observed
Remarks on result:
other: see Remark
Remarks:
Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. Dose level: 10 % test item in 0.9 % NaCl (3 % Sodium ethylenesulphonate). No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no clinical signs were observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control
Dose level:
10 % test item in 0.9 % NaCl (3 % Sodium ethylenesulphonate)
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no clincal signs were observed
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. Dose level: 10 % test item in 0.9 % NaCl (3 % Sodium ethylenesulphonate). No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no clincal signs were observed.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Even if the concentrations at epicutaneous induction was too low according to recent guideline requirements (i.e. the selected concentration induced no mild-to-moderate irritation), the study is acceptable and revealed that Sodiumethylene sulphonate has no sensitisation potential.