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EC number: 265-367-3 | CAS number: 65072-36-8
- 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
In an acute oral toxicity study in rats, conducted according to OECD test guideline 423 and to GLP, an LD50 value of equal to or greater than 2000 mg/kg bw was determined for lithium 2-aminobenzothiazole-6-sulphonate.
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:
- From January 16, 2019 to February 01, 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Slight deviation from OECD guideline recommended humidity range - not expected to impact study findings or validity.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Adopted: 17th December 2001
- Deviations:
- yes
- Remarks:
- The relative humidity values were between 24-56%. OECD guidance states that "the relative humidity should be at least 30%". The investigators stated that "these deviations have no presumed impact on the outcome or integrity of the study".
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- No 440/2008 of 30 May 2008, B.1.tris
- Deviations:
- yes
- Remarks:
- The relative humidity values were between 24-56%. EU (2008) guidance states that "the relative humidity should be at least 30%". The investigators stated that "these deviations have no presumed impact on the outcome or integrity of the study".
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: IR2510181
- Expiration date of the lot/batch: 25 October 2019
- Purity test date: Not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 °C, ≤70 Relative Humidity %)
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: 20% soluble in water
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: 2-ABT lithium sulphonate (off white powder) was freshly formulated at a concentration of 200 mg/mL in distilled water (vehicle)
- Preliminary purification step: Not specified
- Final dilution of a dissolved solid, stock liquid or gel: 200 mg/mL
FORM AS APPLIED IN THE TEST
- Mixture of the off white powder , 2-ABT lithium sulphonate (20% solubility in water), and distilled water (vehicle) - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 12 weeks
- Weight at study initiation: 228-260 g
- Fasting period before study: The animals were fasted the night before treatment
- Housing: 3 animals/cage. Cage type: Type II polypropylene/polycarbonate. Bedding: “Lignocel® 3/4-S Hygienic Animal Bedding” and “Arbocel® crinklets natural” nest building material produced by J. Rettenmaier & Söhne GmbH + Co.KG (D-73494 Rosenberg, Germany)
- Diet: Animals received ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding
and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest, Germany (Batch
number: 639 38520, expiry date: 30 April 2019), ad libitum
- Water: tap water from the municipal supply, as for human consumption from 500 ml bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 - 23.3
- Humidity (%): 24 - 56 (Investigators stated that "due to technical reason, relative humidity values (minimum of 24%) outside the expected range of 30-70% were recorded during the study. These deviations have no presumed impact on the outcome or integrity of the study").
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 16 January 2019 To: 01 February 2019 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: Based on trial formulations with the test item
- Lot/batch no.: 8181118
- Purity: Distilled
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Limit dose - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weights were recorded on the day before treatment, the day of the treatment, after a week and before necropsy (right after the animal was found dead or on the final day of the observation period for the survivors)
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to macroscopic examination - Statistics:
- Not applicable
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The method used was not intended to allow the calculation of a precise LD50 value
- Mortality:
- Out of the 6 animals that received the test material at 2000 mg/kg bw, 1 animal died on day 1
- Clinical signs:
- The animal that died displayed numerous clinical signs of toxicity, including: a hunched back, piloerection, decreased activity (slight or moderate), incoordination and clonic convulsion up to day 1.Those that survived showed hunched back (5/5), piloerection (3/5) and slightly decreased activity (2/5) up to day 4, but no adverse signs of toxicity were observed from day 5 up to the end of the 14 day observation period.
- Body weight:
- Normal body weight gain was observed
- Gross pathology:
- The dead animal had diffuse dark/red discoloration of the non-collapsed lungs and the thymus. These effects were regarded to be due to agonal death and were not substance related.
No adverse macroscopic findings were observed in the rats that were subjected to necropsy on day 14. - Interpretation of results:
- other: Does not warrant classification according to EU CLP criteria
- Conclusions:
- In an acute oral toxicity study in rats, conducted according to OECD test guideline 423 and to GLP, an LD50 value of equal to or greater than 2000 mg/kg bw was determined for lithium 2-aminobenzothiazole-6-sulphonate.
- Executive summary:
In an acute oral toxicity study, conducted according to OECD test guideline 423 and to GLP, six female Wistar rats received a single dose of lithium 2-aminobenzothiazole-6-sulphonate at 2000 mg/kg bw by oral gavage and were observed for clinical signs of toxicity and body weight alterations for 14 days. All animals were then necropsied and underwent a macroscopic examination.
One rat died on day 1. The surviving animals showed hunched back (5/5), piloerection (3/5) and slightly decreased activity (2/5) up to day 4, but no adverse signs of toxicity were noted from day 5 onwards. There were no substance-related adverse effects on body weight gain or macroscopic findings at necropsy.
In this reliable study, the acute oral LD50 value of lithium 2-aminobenzothiazole-6-sulphonate was determined to be equal or above 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- This key experimental study was conducted according to OECD test guideline 423 and to GLP. It is considered to be reliable and sufficient for the basis of classification.
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
Justification for classification or non-classification
The acute oral LD50 of lithium 2-aminobenzothiazole-6-sulphonate was determined to be equal to or above 2000 mg/kg bw. No acute dermal or inhalation data were identified. Therefore, no classification according to EU CLP criteria is required.
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