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EC number: 236-164-7 | CAS number: 13197-76-7
- 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
An acute oral toxicity study is available. A waiver is proposed for acute inhalation toxicity based on the physiochemical properties of the substance. A waiver is proposed for acute dermal toxicity based on the low acute toxicity of the substance.
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:
- 25 May 1995 to 31 Jul 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Betadet S-20
Lot number: 7244
Appearance: transparent viscous liquid
pH: 7.49
Stored: Room temperature, protected from light. - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Eleven Wistar rats Crl (WI)BR (5 males and 6 females) were used. Females were nulliparous and non-pregnant.
Weight on receipt: 80-95 g
Age on receipt: approximately 4 weeks
Source: Charles River
Housing: Makrolon cages with sawdust bedding; Up to five animals of same sex per cage
Acclimatisation period: at least five days
Weight at dosing: 111 g (preliminary experiment) 108-124 g (main study)
Temperature: 19-26 degrees C
Humidity: 32-86%
Photoperiod: 12 dark/light cycle
Diet: Standard rat diet UAR A04C, supplied by Usine d’Alimentation Rationnelle, ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Test substance administered orally by gastric intubation using metal catheter.
Test substance diluted in bidistilled water immediately before administration.
Single dose at volume of 10 mL/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 1 female (preliminary experiment)
5/sex (main experiment) - Control animals:
- no
- Details on study design:
- One female dosed in preliminary experiment. Rat observed twice daily for 7 days.
One group dosed in main experiment which comprised 5 males and 5 females. Rats observed twice daily for 14 days.
Observations included changes in skin and fur, changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, central and autonomous nervous systems, somatomotor activity and behaviour patterns.
Rats were weighed before administration, daily for the first three days and then weekly. Animals were also weighed before being sacrificed.
All animals were sacrificed by carbon dioxide inhalation and subjected to necropsy. - Statistics:
- None
- Preliminary study:
- No mortality.
Slightly soft faeces observed in the course of the following day post-treatment.
No clinical signs for remaining observation period.
Normal evolution of body weight. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No mortality at the limit dose
- Mortality:
- No animals died during the study.
- Clinical signs:
- other: All animals showed slightly soft faeces in the course of the following day post-treatment. No clinical signs for remaining observation period.
- Gross pathology:
- No visible macroscopic lesions related to treatment.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- No deaths occurred at the limit dose of 2000 mg/kg bw.
- Executive summary:
Betadet S-20 was tested for acute oral toxicity in the rat following oral administration. The study followed EC guideline Part B, Method B1 bis. (29 Dec 1992). Slightly soft faeces were observed on the day following administration. There were no other clinical observations. No mortalities, changes in body weight or gross pathology changes were noted. Betadet S-20 is considered to be free of any significant toxicity and does not require classification according to the CLP Regulation.
Reference
No deaths occurred at the limit dose of 2000 mg/kg bw.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Study is GLP compliant and reliable without restrictions.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
Betadet S-20 was tested for acute oral toxicity in the rat following oral administration. The study followed EC guideline Part B, Method B1 bis. (29 Dec 1992). Slightly soft faeces were observed on the day following administration. There were no other clinical observations. No mortalities, changes in body weight or gross pathology changes were noted. Betadet S-20 is considered to be free of any significant toxicity and does not require classification according to the CLP Regulation.
Acute inhalation toxicity
A waiver is proposed based on the physicochemical properties of the substance and the lack of exposure potential.
Acute dermal toxicity
A waiver is proposed based on the low acute oral toxicity of the substance.
Justification for classification or non-classification
Based on the available data, the substance does not require classification for acute toxicity.
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