Registration Dossier

Administrative data

Description of key information

Based on the key study results the substance was considered as non-irritating to skin and to the eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study without detailed documentation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
extended exposure duration of 24 hours, no 72 hours reading after patch removal.
GLP compliance:
no
Remarks:
(Study performed prior to implementation of GLP)
Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5-2.0 kg
- Housing: Animals were housed individually
- ERKA 8300 feed (Robert Koch OHG, Hamm, Germany)
- Diet: ad libitum
- Water: tap water, ad libitum

Type of coverage:
occlusive
Preparation of test site:
other: shaved on two sides and one side was abraded
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 mL of the unchanged test item
Duration of treatment / exposure:
24 hours
Observation period:
48 hours (reading at 0,24 and 48 hours after patch removal)
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: Two sides, each 2.5 x 2.5 cm
- Type of wrap if used: surgical patch on a piece of plaster

REMOVAL OF TEST SUBSTANCE
- Washing: no data

SCORING SYSTEM
- Draize scoring system (OECD 404)


Irritation parameter:
erythema score
Time point:
other: mean 24/48 hours
Score:
0
Max. score:
4
Remarks on result:
other: abraded and non abraded skin
Irritation parameter:
edema score
Time point:
other: mean 24,48 hours
Score:
0
Max. score:
4
Remarks on result:
other: abraded and non abraded skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24/48 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: abraded and non abraded skin
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present skin irritation study with the undiluted test item Sodium ethylenesulphonate, only slight skin irritation was observed in one of six rabbits both on intact and abraded skin which was fully reversed within 48 hours after patch removal.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study without detailed documentation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
Study performed prior to implementation of GLP
Species:
rabbit
Strain:
Himalayan
Vehicle:
unchanged (no vehicle)
Controls:
other: The second eye of the rabbit served as control
Amount / concentration applied:
0.1 mL undiluted test item
Duration of treatment / exposure:
Single application (eyes were washed after 24 hours)
Observation period (in vivo):
72 hours (readings at 1,7,24,48 and 72 hour(s)
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with NaCl solution
- Time after start of exposure: 24 hours
- hand-slit lamp or binocular and fluorescein

TOOL USED TO ASSESS SCORE:
24 hours after start of treatment fluorescein (1:10 000 i.e. 0.01%) was dropped in the cornea of the treated rabbit eye.
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24/48/72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24/48/72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24/48/72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
other: mean 24/48/72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No irritation
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present eye irritation study the undiluted test item Sodium ethylenesulphonate induced no irritation in the rabbit eye.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

Sodium ethylenesulphonate was tested in a primary skin irritation/corrosion study in the rabbit according to OECD guideline no. 404 (Hoechst AG (b), 1976). Six rabbits were exposed to 0.5 mL of undiluted Sodium ethylenesulphonate, applied on two shaved and one abraded skin sites for 24 hours using an occlusive dressing. Observations for erythema and edema were made 0, 24 and 48 hours after patch removal and mean values for 24 and 48 hours were deduced according to the score of Draize. One animal showed slight edema (score 1) 0 and 24 hours after patch removal which was fully reversible within 48 hours. In conclusion, under the conditions of the present skin irritation study with undiluted Sodium ethylenesulphonate, either no skin irritation (5/6 rabbits) or slight reversible skin irritation (1/6) was observed.

Eye irritation

The eye irritation properties of Sodium ethylenesulphonate were examined in an OECD 405 study (Hoechst AG (c), 1976). Six Himalayan rabbits received 0.1 mL of undiluted Sodium ethylenesulphonate, applied to one eye of each rabbit while the other eye, remaining untreated, served as a control. 24 hours after start of exposure the treated eyes were washed with NaCl solution. The eyes were examined 1, 7, 24, 48 and 72 hours after administration of the test substance. The mean scores for 24 and 48 hours were deduced. Under the conditions of the present eye irritation study undiluted Sodium ethylenesulphonate induced no irritation in the rabbit eye.


Justification for selection of skin irritation / corrosion endpoint:
Most reliable study

Justification for selection of eye irritation endpoint:
Most reliable study

Justification for classification or non-classification

Based on the results obtained from testing Sodium ethylenesulphonate was not classified and labelled for skin irritation according to Directive 67/548/EEC (DSD) and according to Regulation (EC) No 1272/2008 (CLP).

Based on the results obtained from testing Sodium ethylenesulphonate was not classified and labelled for eye irritation according to Directive 67/548/EEC (DSD) and according to Regulation (EC) No 1272/2008 (CLP).