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Diss Factsheets
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EC number: 237-525-1 | CAS number: 13826-35-2
- 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
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Details of guidelines not mentioned in publication. Estrogenic activity was estimated in Sprague–Dawley rats
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Texas A&M University
Department of Comparative Medicine
- Age at study initiation: Adult female rats
Fasting period before study: No data available
- Housing: in controlled conditions
Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C):23°C
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): lights on, 06:00 h, lights off, 18:00 h - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on mating procedure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 Days i.e. on PND 22 and continuing until vaginal opening (VO) occurred
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
- Remarks:
- Doses / Concentrations:
1.0, 5.0, or 10.0 mg/kg/day
Basis:
nominal in diet - No. of animals per sex per dose:
- Animals were randomly assigned to treatment groups
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: Yes
BODY WEIGHT: Yes
Time schedule for examinations: daily - Oestrous cyclicity (parental animals):
- No Data
- Sperm parameters (parental animals):
- No Data
- Litter observations:
- No Data
- Postmortem examinations (parental animals):
- No Data
- Postmortem examinations (offspring):
- No Data
- Statistics:
- No Data
- Reproductive indices:
- No Data
- Offspring viability indices:
- No Data
- Clinical signs:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- No effect on body weight gain
- Sexual maturation:
- effects observed, treatment-related
- Description (incidence and severity):
- No differences was observed from control, as all animals the smear on the day of VO was either proestrus or estrus.
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Estrous cycle
- Reproductive effects observed:
- not specified
- Conclusions:
- In a repeated dose toxicity study conducted in female Sprague Dawley Rats, the reprotoxicity test was performed on the pups of the rats at different concentrations. Adult female rats were bred and allowed to deliver pups normally and pups were administered chemical on PND 22 and continuing until vaginal opening (VO) occurred (about 10 days). After that no difference was found between treated and control animals as all had the smear on the day of VO was either proestrus or estrus.
- Executive summary:
In a repeated dose toxicity study conducted in female Sprague Dawley Rats, the reprotoxicity test was performed on the pups of the rats at different concentrations. Adult female rats were bred and allowed to deliver pups normally and pups were administered chemical on PND 22 and continuing until vaginal opening (VO) occurred (about 10 days). After that no difference was found between treated and control animals as all had the smear on the day of VO was either proestrus or estrus.
Reference
Reproductive function: estrous cycle: No differences was observed from control, as all animals the smear on the day of VO was either proestrus or estrus.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 10 mg/kg bw/day
- Study duration:
- subacute
- Quality of whole database:
- The data is K2 level as the data has been obtained from the experimental study published in peer reviewed journal.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a repeated dose toxicity study conducted in female Sprague Dawley Rats, the reprotoxicity test was performed on the pups of the rats at different concentrations. Adult female rats were bred and allowed to deliver pups normally and pups were administered chemical on PND 22 and continuing until vaginal opening (VO) occurred (about 10 days). After that no difference was found between treated and control animals as all had the smear on the day of VO was either proestrus or estrus.
Justification for selection of Effect on fertility via oral route:
In a repeated dose toxicity study conducted in female Sprague Dawley Rats, the reprotoxicity test was performed on the pups of the rats at different concentrations. Adult female rats were bred and allowed to deliver pups normally and pups were administered chemical on PND 22 and continuing until vaginal opening (VO) occurred (about 10 days). After that no difference was found between treated and control animals as all had the smear on the day of VO was either proestrus or estrus.
Justification for classification or non-classification
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.
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.