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EC number: 200-929-3 | CAS number: 76-05-1
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
A single dose of the test substance was administered to male rats by oral route. 3 days after the treatment, the testes were removed for histopathological observations. Under the study conditions, no effect on the weight of the testes and on the spermatogenesis was observed in the test substance treated groups (Lloyd, 1988).
Link to relevant study records
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A scientifically sound study/ publication. No guideline available for such kind of investigation. However, the result obtained is valuable.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In this in vivo study a single dose of the test substance was administered to male rats by oral route. 3 days after the treatment, the testes were removed for histopathological observations.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Alpk/AP (Wistar derived)
- Sex:
- male
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on mating procedure:
- Not applicable: no mating was performed. Male fertility was investigated.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- single dose
- Frequency of treatment:
- single dose
- Details on study schedule:
- not applicable
- Remarks:
- Doses / Concentrations:
0, 10, 25 mg/kg bw
Basis:
other: nominal in water in 5 mL water/kg bw, adjusted to pH 7 using 1.0 M NaOH - No. of animals per sex per dose:
- 10 males per dose
- Control animals:
- yes, concurrent vehicle
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- fertility
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: after single dose treatment
- Basis for effect level:
- other: F1 generation was not assessed
- Remarks on result:
- not measured/tested
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 25 mg/kg bw/day
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
In a developmental toxicity test rats were administered high oral doses (75 or 150 mg/kg bw x d, on gestation days 10 - 20). There was no influence on reproductive-toxic parameters (litter size, surviving rate, growth). Functional disturbances of the liver and kidneys were reversible (for approximately 50 days) (Ema, 2010).
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1997
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female rats were exposed by oral route to trifluoroacetic acid during the gestation (from day 10 to day 20). On day 21, the delivery occured and then the pups were examined until day 49 postnatal (PND 49).
- GLP compliance:
- not specified
- Remarks:
- No information available.
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- not indicated
- Duration of treatment / exposure:
- 10 days: the test substance was administered from GD 10 to GD 20.
- Frequency of treatment:
- daily
- Duration of test:
- not indicated
- Remarks:
- Doses / Concentrations:
0, 75, 150 mg/kg bw/d
Basis:
nominal in water - No. of animals per sex per dose:
- not indicated (around 40 pregnant females per dose and control)
- Control animals:
- yes, concurrent vehicle
- Dose descriptor:
- NOAEL
- Effect level:
- > 150 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Basis for effect level:
- other: not specified
- Remarks on result:
- not determinable because of methodological limitations
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The NOAEL for the effect on developmental toxicity: via oral route was determined to be > 150 mg/kg bw/d (maternal animals).
Toxicity to reproduction: other studies
Description of key information
Three cell culture systems such as isolated Leydig cells, Sertoli cells and Sertoli-germ cell co-cultures were exposed to the test substance. Cell parameters like protein content, lactate and pyruvate production, hormonally stimulated testosterone production and morphology depending on the cell culture type were analysed and the results compared with reference values to assess the effect of the test substance.
Under the test conditions, the test item enhanced the lactate production (Sertoli cells) significantly in a dose-dependent manner and inhibited testosterone output (Leydig cells) but only in the presence of hormone at 5 hours. The no observed-effect level (NOEL) for this effect was established to be less than 1 mM. The test item thus showed only a small effect on the function of Leydig cells and no effect on Sertoli cells (ECHA disseminated dossier, 2014).
Link to relevant study records
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- March - October 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: It is a well documented non-guideline study which was performed in compliance with GLP
- Qualifier:
- no guideline followed
- GLP compliance:
- yes
- Type of method:
- in vitro
- Dose descriptor:
- NOEL
- Remarks:
- effect on testosterone production in Leydig cells under hCG stimulation
- Effect level:
- 1 other: mM
- Conclusions:
- The test item was exposed to three cell culture systems such as isolated Leydig cells, Sertoli cells and Sertoli-germ cell co-cultures. The cell culture systems used are known to be responsive to some positive control compounds and the effects obtained used as reference values for the assessment of the test item. Cell parameters like protein content, lactate and pyruvate production, hormonally stimulated testosterone production and morphology depending on the cell culture type were analysed. Under the test conditions, the test item enhanced the lactate production (Sertoli cells) significantly in a dose-dependent manner and inhibited testosterone output (Leydig cells) but only in the presence of hormone at 5 hours. The no observed-effect level (NOEL) for this effect was established to be less than 1 mM. The test item thus showed only a small effect on the function of Leydig cells and no effect on Sertoli cells.
Reference
Justification for classification or non-classification
Toxicity to reproduction (oral)
The available experimental test data is reliable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Directive 2017/776.
Developmental toxicity (oral)
The available experimental test data is reliable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for developmental toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Directive 2017/776.
Additional information
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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