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EC number: 254-228-2 | CAS number: 38970-76-2
- 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
Acute Toxicity - Oral LD50 550 mg/kg bw for rat (OECD TG 425)
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:
- 28 Jul 2017 - 26 Dec 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Source: ExxonMobil Research & Engineering (Paulsboro, NJ)
Lot # 17-24168
Expiration Date: 20 March 2019 - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Raleigh NC and Stone Ridge NY
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 188 - 261 grams
- Fasting period before study: 16 - 20 hours
- Housing: Individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rat Chow (DIet No. 5012)
- Water (e.g. ad libitum): Tap water, ad-libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Range during study duration: 18.38 to 22.38
- Humidity (%): Range during study duration: 20.3 to 89.7%. While the humidity intermittently exceeded 70%, the fluctuations occurred gradually, during which time the temperature remained relatively consistent and within range.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From 30 Aug 2017 To: 20 Oct 2017 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): Dose volume was based on fasted body weight of each animal, and the dry weight of the test article.
- Justification for choice of vehicle: Per OECD TG 425 with respect to formulation of the dosing preparations, the use of an aqeous solution is recommended wherever possible; substance was soluble in vehicle throughout duration of test.
- Expiration Date: 21 Jul 2018
- Purity: Filtered through 5-micron mesh system - Doses:
- Initially, a single female Sprague Dawley rat was dosed orally by syringe and dosing needle at a dose level of 2000 mg/kg. Since the animal died, additional animals were dosed, one at a time, by a single ordered dose progression (factor 3.2). This resulted in doses of 175, 550 and 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 2000 mg/kg bw: 3 females; 550 mg/kg bw: 4 females, 175 mg/kg bw: 2 females
- Control animals:
- no
- Details on study design:
- Initially, a single female Sprague Dawley rat was dosed orally by syringe and dosing needle at a dose level of 2000 mg/kg. Since the animal died, additional animals were dosed, one at a time, by a single ordered dose progression.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects. Animals were observed twice daily for mortality on Day 1 to Day 14, with the exception of Animals 3 and 8 which were only observed once on study day 5. Body weights were recorded pre-test, weekly, and at death or termination in the survivors.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical observations included, but were not limited to, evaluation of skin and fur, eyes and mucous membranes, respiratory and circulatory effects, autonomic effects such as salivation, central nervous system effects including tremors and convulsions, changes in the level of activity, gait and posture, reactivity to handling or sensory stimuli, altered strength, and stereotypies or bizarre behavior (e.g., self-mutilation, walking backwards). - Statistics:
- The LD50 and 95% Confidence Limits were calculated according using AOT425 StatPgm provided by the U.S. EPA.
- Preliminary study:
- Initially, a single female Sprague Dawley rat was dosed orally by syringe and dosing needle at a dose level of 2000 mg/kg. Since the animal died, additional animals were dosed, one at a time, by a single ordered dose progression.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 550 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 209.7 - < 1 220
- Mortality:
- All three female rats died within approximately 4 hours following the single 2000 mg/kg bw oral dose. Two out of four female rats died by Day 1 following a single 550 mg/kg bw oral dose. Both female rats survived following a single 175 mg/kg bw oral dose.
- Clinical signs:
- At 2000 mg/kg bw abnormal physical signs included soiling and wetness of the anogenital area, ataxia, piloerection, prostration, lethargy, hunched posture, wetness of the nose/mouth area, and yellow diarrhea.
At 550 mg/kg bw, abnormal physical signs included diarrhea, soiling of the anogenital area, piloerection, wetness of the nose/mouth area and anogenital area, lacrimation, prostration, tremors (single instance in one female), nose/mouth area stained yellow, and hunched posture. Surviving animals appeared normal by Day five.
At 175 mg/kg bw, abnormal physical signs included chromorhinorrhea, piloerection, red staining on head and ears, and wetness of the nose/mouth area. All observations occurred as single instances in one of two females except for red staining on head and ears which was present in one female on days five through eight. - Body weight:
- At 2000 mg/kw bw terminal body weight loss was observed among all three females. At 500 mg/kg bw, terminal body weight loss was observed for one of the females that died, while the terminal body weight remained the same as the pretest value for the other. Weight gain was observed among the two surviving animals by study termination. Both females receiving single oral dose of 175 mg/kg bw gained body weight by study termination.
- Gross pathology:
- The gross necropsy of females receiving a single oral dose of 2000 mg/kg bw revealed darker than normal liver, and abnormalities of the gastrointestinal tract. Gross necropsy of the females that died folloing single oral dose of 550 mg/kg bw revealed abnormalities of the gastrointestinal tract, pale areas and darker than normal liver, darker than normal lungs, dark areas on the pancreas, and dark areas on the left kidney. The gross necropsy of the two surviving females following a single oral dose of 550 mg/kg bw revealed no observable abnormalities. The gross necropsy revealed no observable abnormalities in either female receiving a single oral dose of 175 mg/kg bw.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 for Dilithium Salicylate following oral intubation was established at 550 mg/kg bwfor females. This finding warrants classification of Dilithium Salicylate as an acute oral toxicant Category 4 under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
- Executive summary:
Dilithium Salicylate was administered via oral intubation to Sprague-Dawley rats in an Up and Down ordered progression at doses of 2000, 550, and 175 mg/kg to assess the acute oral toxicity. Animals were observed daily for 14 days post dosing. Overt signs of toxicity were apparent at a dose level of 2000 mg/kg and mortality was observed in all three females within 4 hours of dosing. The incidence of death was considered dose related. All animals which survived to study termination were free of abnormalities at postmortem examination (two females at the 550 mg/kg bw dose level, and 2 at the 175 mg/kg bw dose level). All surviving animals displayed increases in body weight over their day 0 values. The LD50 for Dilithium Salicylate based on this data was established at 550 mg/kg bw for females. This finding warrants classification of Dilithium Salicylate as an acute oral toxicant Category 4 under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 550 mg/kg bw
- Quality of whole database:
- It is a reliable study with a klimisch score of 1
Additional information
In the key study (MB Research Laboratories), female rats were administered single oral doses of Dilithium Salicylate at 2000, 550, and 175 mg/kg bw according to OECD test guideline 425 and observed for 14 days. Mortality was observed in all females treated with 2000 mg/kg bw. An LD50 value of 550 mg/kg bw was established.
Justification for classification or non-classification
Dilithium Salicylate is slightly toxic via ingestion where the LD50 is 550 mg/kg bw. This finding warrants classification of Dilithium Salicylate as an acute oral toxicant Category 4 under the Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
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