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EC number: 200-070-4 | CAS number: 50-89-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Toxi-Coop ZRT.
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: Thymidine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult rat, 8 weeks old in first and second step
- Weight at study initiation: Body weight range at starting (first step): 203 - 211 g, body weight range at starting (second step): 195 - 199 g
- Fasting period before study: The day before treatment the animals were fasted. The food, but not water was withheld overnight.
- Housing: Group caging (3 animals/cage), type II polypropylene/polycarbonate cages, laboratory bedding
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 12 days in first step and 13 days in second step
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 8-12 air exchanges/hour by central air-condition system
- Photoperiod (hrs dark / hrs light): Artificial light, from 6 a.m. to 6 p.m.
IN-LIFE DATES:
- From: 18 Sept. 2012
- To: 03 Oct. 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 %
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no.: N83746634
MAXIMUM DOSE VOLUME APPLIED:
- Maximum dose volume: 10 mL/kg bw
DOSAGE PREPARATION:
-Formulations were prepared just before the administration and stirred continuously during the treatment.
CLASS METHOD
- Rationale for the selection of the starting dose: Starting dose was selected on the basis of the available information about the test item. - Doses:
- The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too. Thus, the study was terminated.
- No. of animals per sex per dose:
- Three female rats per treatment group.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter. The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 14 with a precision of 1 g.
- Necropsy of survivors performed: Yes
- Other examinations performed: Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- Not applicable.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occurred at 2000 mg/kg bw single oral dose (limit dose). All female rats in step 1 and also step 2 survived until the end of the 14-day observation period.
- Clinical signs:
- No treatment related symptoms were observed throughout the 14-day post-treatment period in any of the female animals.
- Body weight:
- The mean body weight of the animals corresponded to their species and age throughout the study.
- Gross pathology:
- All animals survived until the scheduled necropsy on Day 14. Slight hydrometra was observed in one treatment group female and moderate hydrometra was recorded in a second treatment group female. The hydrometra is physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortalities occurred after a single 2000 mg/kg bw oral dose (limit dose). There were no treatment related clinical or behavioral signs and no effect on body weights and body weight gains during the study. Autopsy revealed no treatment related pathological changes. Based on the results observed the LD50 was determined to be > 2000 mg/kg bw/day. The LD0 was determined to be 2000 mg/kg bw/day.
- Executive summary:
A study following the acute toxic class method was carried out according to EU Method B.1 tris, OECD Guideline 401 (Acute Oral Toxicity) and OPPTS 870.1100. In a stepwise experimental procedure animals were treated with a starting dose of 2000 mg/kg bw (limit dose). The test item was administered to three female rats per oral gavage. Over a period of 14 days there were no mortalities observed at the 2000 mg/kg bw dose level. Therefore, treatment with 2000 mg/kg bw was repeated on further three female rats. Again, no mortalities were observed over a period of 14 days. All animals were periodically weighed, observed for clinical and behavioral symptoms. Gross pathological examination was carried out on the 14th day after the treatment.
No lethality was noted at single oral dose (gavage) of 2000 mg/kg bw (limit dose). No clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behavior of experimental animals were normal. The body weight development was undisturbed in all animals. All animals survived until the scheduled autopsy on day 14. All organs of all experimental animals proved to be free of treatment related gross pathological changes.
Based on the results observed the LD50 was determined to be > 2000 mg/kg bw/day (limit dose). The LD0 was determined to be 2000 mg/kg bw/day (limit dose).
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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