Registration Dossier

Administrative data

Description of key information

The skin and eye irritation/corrosion tests used for read-across were performed on a structural analogue . 
The studies were not performed according to OECD guideline and GLP conditions.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
May 3 to 10, 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The skin irritation test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows clearly that the substance is not irritant. Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts ) was used as supporting substance due to the structural analogy. They are both in the category of the long linear and branched chain alcohols. Key points are that the members share the same structural features, similar metabolic pathways, common mode of ecotoxicological action and common levels and mode of human health related effects. Member of the long chain alcohols are of a low order of toxicity following acute and repeated exposures. The overall toxicological profile of the sub-categories of linear and essentially linear alcohols is qualitatively and quantitatively similar for all end points. Reference: OECD SIDS Long chain alcohols, April 18-21, 2006
Principles of method if other than guideline:
The skin test ratings were interpreted according the Council Dir. 83/467/EEC adapting to technical progress for the 50th time the Council Dir. 67/548/EEC.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding "Conelli" - Arona, Italy
- Weight at study initiation: 2,5 - 3,5 kg
- Housing: stainless steel cages of mm 450 x 500 x 380 with automatic washing cycle
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered water from local network

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 °C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): at least 25 times per hour
- Photoperiod (hrs dark / hrs light): 12 h/day
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
10 cm of area has been designated for the position of the patch. Square gauze pads have been used, secured in place by thin bands of adhesive tape. The entire trunk of the animal has been then wrapped with rubberized cloth.
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, 72 hours and after 5, 7 days
Number of animals:
3 males
Details on study design:
Each animal had a non-treated area and a treated area with test material. Each animal served as its own control.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 5 and 7 days
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 5 and 7 days
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material "D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts", in according with EEC Directives 91/325, can be considered non irritant.
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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
May 3 - 10, 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The eye irritation test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows that the substance is an eye irritant. Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts ) was used as supporting substance due to the structural analogy. They are both in the category of the long linear and branched chain alcohols. Key points are that the members share the same structural features, similar metabolic pathways, common mode of ecotoxicological action and common levels and mode of human health related effects. Member of the long chain alcohols are of a low order of toxicity following acute and repeated exposures. The overall toxicological profile of the sub-categories of linear and essentially linear alcohols is qualitatively and quantitatively similar for all end points. Reference: OECD SIDS Long chain alcohols, April 18-21, 2006
Qualifier:
according to
Guideline:
other: EEC directive 91/325
Principles of method if other than guideline:
Results were interpreted according to the Council Dir. 83/467/EEC adapting for the 50th time Council Dir. 67/548/EEC .
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeding "Conelli" - Arona, Italy
- Weight at study initiation: 2,5 - 3,5 kg
- Housing: stainless steel cages of mm 450 x 500 x 380 with automatic washing cycle
- Diet (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered water from local network

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2 °C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): at least 25 times per hour
- Photoperiod (hrs dark / hrs light): 12 h/day
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml/animal
Observation period (in vivo):
1-24-48 and 72 hours and 7 days from instillation
Number of animals or in vitro replicates:
3 males
Details on study design:
Each animal had an eye treated and the other eye which remained untreated, as a control.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
1
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, when administered by ocular route to rabbits, in single administration, in according with EEC Dir. 91/325, is to be considered irritant for the eye.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Both studies, performed in the year 1993, did not follow the OECD guidelines. However the conditions applied in the study are acceptable and the results show that the substance is not irritant for skin, but it is an eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
The study refers to "D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts", a structurally related substance to "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite". The skin irritation test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows clearly that the substance is not irritant.

Justification for selection of eye irritation endpoint:
The study refers to "D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts", a structurally related substance to "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite". The eye irritation test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows that the substance is an eye irritant.

Effects on eye irritation: irritating

Justification for classification or non-classification

Basing on the tests results and following the REGULATION (EC) No 1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures) the substance "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite" need to be classified as eye irritant:

 

Skin corrosion/irritation: not classified

Hazard statement: none

 

Serious eye damage/ eye irritation: Eye damage 2

Hazard statement: H319: Causes serious eye irritation.