Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 428-100-3 | CAS number: 94239-04-0
- 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
Oral: OECD 408, rat. No effects were observed in reproductive organs at the highest concentration tested 12500 mg/kg diet (corresponding to 947.0 and 1133.2 mg/kg bw/day for males and females, respectively). Reliability = 1.
Additional information
The reproductive requirement is waived as no effects were observed in male or female reproductive organs in a 90-day repeated dose feeding study and a prenatal developmental toxicity study (OECD 414) revealed no teratogenic effects at 200 mg/kg (the highest dose tested).
Short description of key information:
The reproductive requirement is waived as a 90-day repeated dose feeding study and prenatal developmental toxicity study (OECD 414) are available for the test substance.
Effects on developmental toxicity
Description of key information
Oral: NOAEL; OECD 414, rat. NOAEL for teratogenicity was ≥200 mg/kg/day, the highest dose tested. Reliability = 2.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- Substance ID: F6TF
Purity: 99.56% - Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 12 weeks
- Weight at study initiation: approximately 200-250 g
- Fasting period before study: No
- Housing: Plastic cages and numbered individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25°C
- Humidity (%): 40-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Prescribed amounts of the test substance were mixed with distilled water according to the prescribed doses at the time of administration.
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Not reported
- Duration of treatment / exposure:
- Days 6 to 15 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
- Dose / conc.:
- 50 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- No. of animals per sex per dose:
- A minimum of 15 pregnant rats/dose were examined
- Control animals:
- yes, concurrent vehicle
- other: A positive control group was included, but the positive control material was not reported.
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Every 3 days, including the day of dissection
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20 - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No data - Statistics:
- T-test method was used for body weight growth of pregnant rats, body length, tail length, and body weights of foetuses. Χ2-test method was used for absorptivity, mortality, and teratogenic rate of foetuses.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Three rats in 100 mg/kg dose group and six rats in 200 mg/kg dose group died during the test period.
- Body weight and weight changes:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Three rats died at 100 mg/kg and 6 rats died at 200 mg/kg during the test period. - Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Fetal body weight changes:
- effects observed, non-treatment-related
- Changes in sex ratio:
- no effects observed
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Delayed sternebral ossification was observed at 200 mg/kg.
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
A slight increase in resorptions was observed at 200 mg/kg, without adverse effects on mean litter size. Reduced mean tail length and fetal weight were observed at 100 and 200 mg/kg. Delayed sternebral ossification was observed at 200 mg/kg. - Key result
- Basis for effect level:
- other:
- Developmental effects observed:
- not specified
- Conclusions:
- The test substance has toxic effects on parents and may cause delay of fetus growth at doses above 100 mg/kg but no teratogenic effects.
- Executive summary:
Sprague Dawley (SD) rats were used as test animals. Three dose groups (50, 100, and 200 mg/kg body weight/day) were set based on the results of the preliminary test. A negative control and a positive control were used synchronously. Pregnant rats were administered daily by oral gavage on the 6th to 15th day of gestation and were sacrificed at the 20th day of gestation. At necropsy, the uteri were removed and weighed. The number of corpora lutea, live foetuses, early dead foetuses, late dead foetuses, and resorptions were recorded. The sex, body weight, body length, tail length of each live foetus and the weight of the placenta were recorded as well. External, skeletal, and visceral examinations were conducted. All data were processed.
The test substance has toxic effects on parents and delayed foetal growth at 100 and 200 mg/kg by oral administration. At 200 mg/kg, it also delayed the skeletal growth of the foetus. No teratogenic effects were found at 50, 100, or 200 mg/kg. Based on the findings of the study, the test substance would be considered to be a toxicant at dose levels greater than or equal to 100 mg/kg, based on decreased total number of pregnant rats, delayed foetus growth, and delayed skeletal growth. No teratogenic effects were observed at 200 mg/kg (the highest dose tested).
Reference
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
Additional information
Female Sprague Dawley rats were exposed to the test substance via gavage once daily from gestation day 6 through 15 at doses of 50, 100, and 200 mg/kg/day. The no-observed-adverse-effect-level for maternal and developmental toxicity was 50 mg/kg, based on maternal mortality and delayed foetal and skeletal growth at ≥100 mg/kg/day. The NOAEL for teratogenicity was ≥200 mg/kg/day, based on no effects observed at the highest dose tested.
Toxicity to reproduction: other studies
Additional information
No effects were observed in reproductive organs in a repeated dose 90-day feeding study in rats at doses of 500, 2200, and 12500 mg/kg, corresponding to mean daily intake values of 44.3, 218.8, and 947.0 mg/kg/day for males and 48.1, 246.9, and 1133.2 mg/kg/day for females.
Justification for classification or non-classification:
Based on the findings of no effects in male and female reproductive organs in a subchronic 90-day feeding study, as well as the fact that the test substance is not uniquely toxic to the developing fetus, the substance does not need to be classified for reproductive or developmental toxicity according to the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.