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EC number: 241-769-4 | CAS number: 17791-81-0
- 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
oral acute toxicity:
LD50 value > 2000 mg/kg bw for the pure substance (extrapolation based on results with mixture)
dermal acute toxicity:
LD50 value > 2000 mg/kg bw for the pure substance (extrapolation based on results with mixture). Read across was done to hexasodium 2,2'-{ethene-1,2-diylbis[(3-sulfonato-4,1-phenylene)imino(6-morpholin-4-yl-1,3,5-triazine-4,2-diyl)imino]}dibenzene-1,4-disulfonate, CAS 52301-70-9
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:
- 1994-10-25 and 1994-11-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-conform study, method according to OECD guideline 401 and method B1 of Commission Directive 92/69/EEC, 49% mixture was tested
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, U.K.
- Age at study initiation: approx. 5 to 8 weeks
- Weight at study initiation: males 150 - 160 g, females 148 - 166 g
- Fasting period before study: overnight fast immediately before dosing, approx. 2 h after dosing
- Housing: housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: rat and mouse expanded diet no. 1, special diets services limited, Witham, Essex, U.K., ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 48 - 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 1/2, 1, 2 and 4 hours after dosing, subsequently once daily; weighing: before experiment, on day 7 and 14
- range-finding study was performed to define the dose level for the main study
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight - Statistics:
- not required
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systematic toxicity were noted during the study. Dark red staining of the fur was noted in all males from 1-hour observation to the day 1 observation, and in one female at the 4-hour and 1 day observations.
- Gross pathology:
- No abnormalities were noted at necroscopy.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP-conform and guideline study
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable method. For justification of read across please refer to IUCLID5 section 13.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- other: Gelbsilber
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean: 2222 g
- Housing: single
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10/14 - Type of coverage:
- occlusive
- Vehicle:
- other: gum arabic
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 200 - 300 square cm
- Type of wrap: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: with luke warm water and sponge
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied: 2.5 mL/kg
- Concentration: 80 %
- Constant volume or concentration used: yes
- For solids, paste formed: no data
VEHICLE
- Concentration: 1% - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8 days
- Frequency of observations and weighing: weighing after 8 days
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: day 1 to day 8: no resorptive symptoms day 1: Erythema in 4/6 rabbits day 2 to 6: no abnormalities detected in 6/6 animals day 8: scaling found at 1/6 animal
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Scientifically acceptable method.
Additional information
Acute oral toxicity
An acute oral toxicity study (key study) was perfomed by using Sprague-Drawley strain rats. Based on the results of the range-finding study, the test substance (49% act. integr.) was administered by gavage to 5 animals per 5 sex in doses of 2000 mg/kg bw. The animals were observed for mortality and signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. The results indicated no deaths. No signs of systemic toxicity were noted during the study. Dark red staining of the fur was noted in all males from the 1 -hour observation to the day 1 observation, and in one female at the 4 -hour and 1 day observations. Individual bodyweights were recorded prior to dosing on Day 0 and on Day 7 and 14. All animals showed expected gain in bodyweight during the study. No abnormalities were noted necropsy. The acute oral LD50 of the test material in rats was found to be greater than 2000 mg/kg bw. Since no deaths, no signs of systemic toxicity, normal bw gain, no abnormalities at necropsy were observed in the oral acute toxicity key study with the 49% mixture, the LD50 for the pure substance is also expected to be greater than 2000 mg/kg bw.
Acute dermal toxicity
An acute dermal toxicity study was performed by using yellow-silver rabbits similar to the OECD guideline 402. 3 males and 3 females were treated with the read across substance hexasodium 2,2'-{ethene-1,2-diylbis[(3-sulfonato-4,1-phenylene)imino(6-morpholin-4-yl-1,3,5-triazine-4,2-diyl)imino]}dibenzene-1,4-disulfonate (CAS 52301-70-9; 73.4% act. ingr.) for 24 hours by using an occlusive dressing. Erythema were noted in 4 of 6 animals at the 24 -hours observation. Scuffing was observed on day 7 and 8 after the application. The acute dermal LD50 of the read across substance in rabbits was found to be greater than 2000 mg/kg bw. Since no deaths and normal bw gain was observed, the LD50 for the pure substance is also expected to be greater than 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
One reliable study available.
Justification for selection of acute toxicity – dermal endpoint
One reliable study available.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. As a result
the test substance is not considered to be classified for acute oral or
dermal toxicity under Regulation (EC) No 1272/2008, as amended for the
seventh time in Regulation (EC) No 2015/1221.
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