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Diss Factsheets
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EC number: 700-755-2 | CAS number: -
- 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
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
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
Oral: OECD 414, rat. NOAEL for teratogenicity was 1000 mg/kg/day, the highest dose tested. Reliability = 1.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labeling and/or risk assessment. Although data provided have a report year after 2008, the study was performed to fulfill needs required by government regulators and/or for product stewardship purposes. DuPont’s stewardship principle states that “We will adhere to the highest standards for the safe operation of facilities and the protection of our environment, our employees, our customers and the people of the communities in which we do business”. The study was carried out in accordance with our internal Product Stewardship standard which is part of the American Chemical Council’s “Responsible Care Program”. This study was not performed to fulfill an information requirement under REACH, but since the test data were already available they were provided as part of the REACH submission.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF Japan The Guidelines Related to the Study Reports for the Registration Application of Pesticides, 12 Nousan Number 8147
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 69-72 days
- Weight at study initiation: 228 g to 285 g
- Housing: Individually in solid bottom cagging with bedding containing Envirodry(TM) as enrichment
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test substance was dosed undiluted. Animals were dosed daily at approximately the same time by gavage. The amount of test substance each rat received was based on the most recently collected body weight and the density of the test substance. Control rats were dosed with deionized water at the same volume as the high dose group.
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
- Duration of treatment / exposure:
- Gestation Days 6-20
- Frequency of treatment:
- Daily
- Duration of test:
- 21 days
- No. of animals per sex per dose:
- 22 females per dose
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Doses were selected based on results from previous toxicity studies and the limitations of dose volume when the test substance was dosed neat.
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once on day 4G; twice daily on days 6-20G (during weighing and at least 2 hours post-dosing); once on day 21G
BODY WEIGHT: Yes
- Time schedule for examinations: daily on days 4 and 6-21G
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined: days 4, 6, 8, 10, 12, 14, 16, 18, 20, and 21G
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 21
- Organs examined: a gross external and a visceral examination were performed. - 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 early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: all per litter (skulls of half per litter)
- Head examinations: Yes: half per litter - Statistics:
- See Table below.
For litter parameters, the proportion of affected fetuses per litter or the litter mean were used as the experimental unit for statistical evaluation. Significance was judged at p < 0.05. - Details on maternal toxic effects:
- Maternal toxic effects:no effects
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
There was a statistically significant increase in fetal sex ratio at 500 and 1000 mg/kg/day. These instances of statistical significance are attributed to an atypically low value for the concurrent control group. These changes are not considered test substance-related because fetal sex is determined at the time of conception on GD 0 and dosing was not initiated until GD 6. Fetal sex ratio is useful as an endpoint on a developmental toxicity study that employs the current design only to the extent that one can infer whether or not there is a gender-specific difference in in utero survival. In this case, there were no effects on in utero survival. Therefore, the changes in the means are considered to have occurred by chance. The mean values for all groups in the current study fall within typical published ranges generally seen in control populations. - Dose descriptor:
- LOEC
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- changes in sex ratio
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- NOAEL (maternal) = 1000 mg/kg (highest dose tested)
NOAEL (developmental) = 1000 mg/kg (highest dose tested)
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). - Executive summary:
The objective of the study was to evaluate the potential maternal and developmental toxicity of the test substance in rats. The test substance was administered via once-daily oral gavage as neat material. Groups of 22 time-mated Crl:CD(SD) rats were administered the test substance at dose levels of 0, 250, 500, or 1000 mg/kg/day. Dosing was initiated on gestation day (GD) 6 and continued through GD 20. During the in-life portion of the study, maternal body weights and food consumption as well as clinical observations data were collected. On GD 21, dams were euthanized and underwent a gross external and internal examination. The gravid uteri were removed, weighed, and dissected. Uterine contents were described and fetuses were counted, weighed, sexed, and examined for external, visceral, head, and skeletal alterations.
There was no evidence of test substance-related maternal or developmental toxicity at any dose level tested and the no-observed-adverse-effect level (NOAEL) was 1000 mg/kg/day for both maternal and developmental toxicity.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- 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
In a rat developmental toxicity study, no maternal or developmental toxicity was observed in rats following exposures up to 1000 mg/kg/day. Based on this information, the NOAEL for developmental toxicity was 1000 mg/kg/day, which was the highest dose tested.
Justification for selection of Effect on developmental toxicity: via oral route:
OECD Guideline, GLP study
Justification for classification or non-classification
The test substance did not produce adverse developmental effects at any dose level tested in a rat prenatal developmental toxicity study. The substance does not need to be classified for developmental toxicity according to the EU Directive 67/548/EEC. However, due to the lack of a dedicated reproductive toxicity study, the substance cannot be classified for reproductive toxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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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