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EC number: 701-354-5 | 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
There is a good quality GLP compliant acute oral toxicity study (Oral LD50 OECD401) which is reasonably modern (1987) including 5 males and 5 females.
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:
- February 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: No data on batch no and composition. Study according to guideline/standards (reliability score can be 1).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- 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, UK
- Age at study initiation: no info except for young adult
- Weight at study initiation: 89 ± 6 g (males), 90 ± 2 g (females)
- Fasting period before study: overnight prior to dosing
- Housing: five per sex in grid-bottomed polypropylene cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 49-61
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 6 To: 20 February 1987 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not indicated
- Amount of vehicle (if gavage): 20 mL/kg
- Justification for choice of vehicle: no info
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
DOSAGE PREPARATION (if unusual): the test material was neutralised to a pH of 7.0 using 1.0 M citric acid and then diluted with
distilled water to give a dose volume of 20 mL/kg at a dose level of 5000 mg/kg
- Doses:
- 5000 mg/kg bw
- 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:frequently after dosing and then daily; BW weekly
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- Not required
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: no mortality
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No abnormalities noted
- Other findings:
- No
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- As the oral LD50 is in excess of 5000 mg/kg bw, no classification according to OECD-GHS is required.
- Executive summary:
The toxicity of the test material was assessed following its oral administration to a group of five male and five female rats. The procedure used meets the requirements of the limit test for acute oral toxicity described by the OECD (Organisation for Economic Co-operation and Development). Following overnight fasting rats were administered the test material, by peroral injection, at a dose level of 5000 mg/kg bw. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. No effects to treatment were observed throughout the duration of the study and no abnormalities were detected at necropsy. The results of this study indicate that the test material, Ampholak YCE, has no toxic effect when administered as a single oral dose to the rat at a dose level of 5000 mg/kg bw. No classification is needed according to GHS-OECD.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- There is a good quality GLP compliant acute oral toxicity study (Oral LD50 OECD401) which is reasonably modern (1987) including 5 males and 5 females. This study showed no indications of toxic effect at the 5000mg/kg dose level tested.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Acute inhalation toxicity, the test substance is manufactured and sold as a 30% solution in water, inhalation exposure is not expected to be a normal route of exposure. The test substance showed very low acute toxicity via the oral route, the oral LD50 being greater than 5000ppm. Therefore acute inhalation testing has not been performed, the study is waived as not scientifically justified.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- The test substance has acute oral toxicity >5000 mg/kg bodyweight, the acute dermal LD50 can therefore be assumed to also be greater than 5000mg/kg bodyweight as dermal absorption is not expected to exceed oral absorption due to it high water solubility. Therefore testing for acute dermal toxicity is waived as not scientifically justified.
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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