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EC number: 940-678-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The acute oral toxicity test was performed according to OECD Short-term and Long-term toxicology groups and WHO pubblication: Environmental Health criteria 6, Principles and method for evaluating the toxicity of chemicals, part 1, Geneva 1979.
The acute dermal toxicity was investigated on the substance "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite" according to OECD guideline 402, EPA OPPTS 870.1200 (Acute Dermal Toxicity) and EC 440/2008, following GLP conditions.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 3 to 17, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The acute oral toxicity 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 toxic. Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts) was old name for EUCAROL AGE SS/ND before REACH regulatory - new nomenclature. The substance was identified with: CAS: 151911-53-4 EC: 500-331-5
- Principles of method if other than guideline:
- The dose has been choosen in according with EEC directive 67/548.
References:
- OECD Short-term and Long-term toxicology groups.
- WHO pubblication: Environmental Health criteria 6, Principles and method for evaluating the toxicity of chemicals, part 1, Geneva 1979 - GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: "Morini" - S.Polo d'Enza, Italy
- Weight at study initiation: 140-200 g
- Fasting period before study: pellet complete diet
- Housing: transparent polycarbonate cages of mm 425 x 266 x 180
- Water : filtered water from local network
- acclimation: at least 1 week before the start of the test
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.+/- 2 °C
- Humidity (%): 55 +/- 15 %
- Air changes (per hr): 25 times
- Photoperiod (hrs dark / hrs light): 12h/day - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days at frequent intervals during the first day and then daily
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no animals died
- Clinical signs:
- other: Slight piloerection in male rats no. 1, 3, 4, 5 and female rats no. 4, 5. This symptomatology is disappeared after 9 day from begining the study.
- Gross pathology:
- Slight mucosa enteritis in male rats n.1, 3
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 was higher than 5000 mg/kg; no classification is required.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- April 12 - 27, 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Eucarol AGE 91/S ( Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite ) was used as supporting substance due to the structural analogy. It can be expected a similar structural features.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: EC 440/2008
- Principles of method if other than guideline:
- Commission Regulation (EC) No 440/2008, L 142, Annex Part B of 30 May 2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species/strain: healthy rats, WISTAR rats Crl: WI(Han) (full barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female (non-pregnant and nulliparous).
Number of animals: 5 male and 5 female
Age at the beginning of the study: males: 8 weeks old; females: 11 weeks old
Body weight on the day of administration: males: 225 – 250 g; females: 210 – 233 g
The animals were derived from a controlled full-barrier maintained breeding system (SPF).
Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1307)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 24/11/2010)
- Adequate acclimatisation period (at least five days)
Approximately 24.5 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application. - Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test item was applied at a single dose, uniformly over an area which was approximately 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
At the end of the exposure period the residual test item was removed by using aqua ad injectionem. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
The active component of the test item is diluted in water (50 %); to assure the dose of 2000 mg/kg a correction factor of 2 was considered for preparation of the dressing with the test item, which has been consequently applied at a dose of 4000 mg/kg body weight. - No. of animals per sex per dose:
- 5
- Details on study design:
- All animals were observed for 14 days after dosing.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality
- Clinical signs:
- other: No treatment-related effects were observed
- Gross pathology:
- No treatment-related effects were observed
- Other findings:
- No erythema or oedema was observed. Desquamation was observed in 1 out of 5 female animals.
Eschar was observed in 5 out of 5 male and 4 out of 5 female animals. Scratches were observed in 3 out of 5 male animals.
All signs of irritation were reversible within the observation period. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight (based on the active components) was associated with no mortality and neither signs of toxicity but minor signs of irritation.
The dermal LD50 was determined to be > 2000 mg/kg body weight (based on the active components). - Executive summary:
Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight (based on the active components) was associated with no mortality and neither signs of toxicity but minor signs of irritation.
The dermal LD50 was determined to be > 2000 mg/kg body weight (based on the active components).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
The acute oral toxicity 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 toxic (LD50 > 5000 mg/kg b.w.) .
The acute dermal toxicity test was performed in the year 2011, under GLP conditions and following the OECD guidelines. Under the conditions of the study, neither mortality nor signs of toxicity but minor signs of irritation were observed.
The dermal LD50 was determined to be > 2000 mg / kg body weight (based on the active components).
Justification for selection of acute toxicity – oral endpoint
Eucarol AGE SS (D-Glucopyranose, oligomeric, 6-(hydrogen 2-sulfobutanedioate), 1- (coco alkyl) ethers, sodium salts) was old name for EUCAROL AGE SS/ND before REACH regulatory - new nomenclature.
The substance was identified with:
CAS: 151911-53-4
EC: 500-331-5
The acute oral toxicity 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 toxic.
Justification for selection of acute toxicity – dermal endpoint
Study was performed with "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite". The study was carried out in GLP and according to an OECD standard method.
Eucarol AGE 91/S ( Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with disodium sulfite ) was used as supporting substance due to the structural analogy.
It can be expected a similar structural features.
Justification for classification or non-classification
Basing on the results above reported and following the REGULATION (EC) No 1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures) the substance "Sulfonation products of disodium sulfite with (esterification products of C10-16 (even numbered) Alkyl Polyglycosides with maleic anhydride)" does not required classification for acute toxicity.
Oral Toxicity:
Classification : not required
Signal word : none
Hazard statement (Oral) : none
Dermal toxicity
Classification : Not required
Signal word : None
Hazard statement : None
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