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EC number: 617-560-2 | CAS number: 84377-83-3
- 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
Two studies have been conducted to assess the oral toxicity of the test substance: Dosing by gavage of the test substance, suspended in water for irrigation, to groups of 10 male and female mice to determine toxic effects from oral exposure to the substance, showed no toxicity up to a dosage of 1000 mg/kg body weight. Further testing in a group of 10 female mice demonstrated that the test substance has a very low order of acute oral toxicity, with a LD50 value in excess of 5 g/kg. No reaction to treatment or macroscopic damage to tissue were observed at that dose level.
A single study was conducted where dermal exposure of rats to the test substance at a concentration of 3400mg/kg did not result in apparent toxicity or skin irritation.
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline was specified. Dosing by gavage of the test substance, suspended in water for irrigation, to groups of 10 male and female mice to determine toxic effects from oral exposure to the substance.
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- mouse
- Strain:
- other: CRH (Glaxo Group Research Limited, Harefield Breeding Unit)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Weight range: 16-20g.
Not starved prior to treatment - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Irrigation water
- Details on oral exposure:
- Material was formulated as a suspension in Water for Irrigation, using a Silverson blender, and dosed by gavage at a dose volume of 1ml/20g, to groups of 10 male and 10 female mice.
- Doses:
- 1ml suspension / 20 g of animal
1000 mg/kg - No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- Observation period: 14 days
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No animals died due to ingestion of the test material.
- Clinical signs:
- other: Nothing abnormal detected
- Gross pathology:
- No significant lesions were seen at autopsy although Kidneys of 5 males and 6 females were slightly pale. These tissues were submitted for histopathological examination and were found to be microscopically normal.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- 'Trityl DMF solvate' has a low order of acute oral toxicity in mice with an LD50 value in excess of 1000 mg/kg. No signs of toxicity were seen at that dose level.
- Executive summary:
Dosing by gavage of the test substance, suspended in water for irrigation, to groups of 10 male and female mice to determine toxic effects from oral exposure to the substance, showed no toxicity up to a dosage of 1000 mg/kg body weight.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No test guideline was mentioned in the study report. Material was formulated as a suspension in deionised water, using a Silverson blender, and dosed by gavage at a dose volume of 1ml/20g, to groups of 10 mice.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Material was supplied by Dr PA Wilkinson (Greenford) and was stored at 4C before use. Material is intermediate in the synthesis of ceftazidine.
- Species:
- mouse
- Strain:
- other: CRH (Glaxo Group Research breeding unit, Harefield)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- weight range: 16-20g
Not starved before treatment - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionised water
- Details on oral exposure:
- Material was formulated as 10% w/v suspension in deionised water and dosed by gavage.
- Doses:
- 1ml / 20g
- No. of animals per sex per dose:
- 10 female
- Control animals:
- not specified
- Details on study design:
- Observation period of 7 days
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mice were found dead
- Clinical signs:
- other: No signs of toxicity were observed in the test animals
- Gross pathology:
- All mice were killed at the end of the observation period and examined macroscopically. All tissues appeared normal and none were submitted to histopathological examination.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance has a very low order of acute oral toxicity to female mice with LD50 value in excess of 5 g/kg. No reaction to treatment or macroscopic damage to tissue were observed at that dose level.
- Executive summary:
Dosing by gavage of the test substance, suspended in water for irrigation, to groups of 10 mice to determine toxic effects from oral exposure to the substance, showed no toxicity at a dosage of 5000 mg/kg body weight.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May-June 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline is mentioned in the study report. Percutaneous administration of 1 g substance per rat took place.
The rats were tested in accordance with the method used in an older documented report (internal report number 77TM7 of 28 January 1977) - GLP compliance:
- no
- Remarks:
- The study was conducted prior to the requirement for GLP for such studies
- Test type:
- other: Percutaneous administration of 1 g substance per rat took place.
- Limit test:
- yes
- Specific details on test material used for the study:
- The material was supplied by Dr P.A. Wilkinson (Greenford) and was stored at 4C before use. It is an intermediate in the synthesis of ceftazidime.
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- (SDG)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male SDG rats weighing 290 to 292 were used. They were obtained from the Glaxo Group Research Ltd., breeding unit (Harefield). The rats were housed singly.
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 7 day observation period
- Doses:
- A dose of 1 g/rat was used throughout. (3.4 g/kg body weight)
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 3 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred
- Clinical signs:
- other: No signs of local or systemic effects toxity were shown.
- Gross pathology:
- Not specified
- Other findings:
- No irritation (erythema or oedema) was observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- "**1132/4 DMF" has a low order of percutaneous toxicity in the rat with values greater than 3.4 g/kg bw.
- Executive summary:
Three male SDGrats were percutaneously exposed to 1 kg/rat of 1132/4 DMF to determine acute toxicity and irritation through the dermal route. There were no mortalities and no local or systemic toxicity was observed. Finally, the substance was not found to be irritant to skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 3 400 mg/kg bw
Additional information
Justification for classification or non-classification
The substance has been tested in mice by oral gavage at 1000 and 5000 mg/kg bw, no toxicity was observed. Additionally, percutaneous testing with the substance in rats established that the LD50 exceeds 3400 mg/kg bw, with no apparent toxicity or irritation resulting from the exposure. From the results above, it can be predicted that inhalation exposure of test animals would not result in toxicity by that route upto the limit dose of 5mg/ L/4 hours.
Accordingly, the classification criteria for acute toxicity according to 1272/2008/EC are not met.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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.