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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
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
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
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
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Please refer to details on study design (Traditional test)
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)
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation

 

In a guinea pig maximisation test according to OECD 406 and GLP guideline (Hoechst AG (a), 1988) a test solution containing 30 % Sodium etyhlenesulphonate was used. For the determination of the non-irritating concentration and of the intradermal tolerance a range finding test was conducted. Thereby, 0.5 mL undiluted test solution (30 % Sodium ethylenesulphonate) induced erythema, slight edema and pustules whereas 10 % test solution (3 % Sodium ethylenesulphonate) induced no skin irritations after epicutaneous occlusive exposure (24 hours) on the right and left flank of 6 animals. In the main study ten female Pribright-Hartley guinea pigs were treated on day 1 by two intradermal injections on the back in three areas with 50 % Freund´s Adjuvant (1. area, 2 x 0.1 mL), 5 % test solution in 0.9 % NaCl (2. area 2 x 0.1 mL, 1.5 % Sodium etyhlenesulphonate) and 5 % test solution in Freund´s Adjuvant (3. area, 2 x 0.1 mL, 1.5 % Sodium etyhlenesulphonate). On day 9, ten animals received 0.5 mL of the test solution by dermal application on the intradermal injection area (back), occlusive, for an exposure time of 48 hours. Thereby, animals were treated with 10 % test solution in 0.9% NaCl (3 % Sodium ethylensulphonate). Five control animals and five animals of a satellite group were treated with a 0.9 % NaCl solution. On challenge exposure (day 22) animals (ten for the treated group and five for the control group) were treated with 0.5 mL of the test solution on the left flank by an occlusive dressing for an exposure time of 24 hours. All animals received 10 % test solution in 0.9 % NaCl (3 % Sodium ethylenesulphonate). 24h and 48h after the occlusive gauze was removed the animals of the treated and the control goup revealed no signs of skin irritation

No clinical signs were observed during the study period. The body weight gains of the treated animals were mostly normal. Two animals of the control group showed only a slight increase in body weight development. After intradermal induction in animals treated with 50 % Freund´s Adjuvant and with 5 % test solution in Freund´s Adjuvant redness and edema on the injection site were observed which turned into indurations. After the dermal induction, the control and satellite group showed injection sites with open wound, scabbing and necrosis when the occlusive gauze was removed (day 11). In conclusion, 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.

Migrated from Short description of key information:
Sodium ethylenesulphonate was not sensitizing in the guinea pig maximisation test

Justification for selection of skin sensitisation endpoint:
Most reliable study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results obtained in the key skin sensitisation test, Sodium ethylenesulphonate is not subject to classification for sensitization according to Directive 67/548/EEC and according to Regulation (EC) No 1272/2008.