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Diss Factsheets
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EC number: - | 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
Description of key information
A study on fertility (OECD 422, GLP) with wistar rats is currently ongoing.
This study is going to be considered to give sufficient information to permit the conclusion that the substance is not toxic to reproduction. For that reason no extended one-generation study is proposed.
Link to relevant study records
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the extended one-generation reproductive toxicity study does not need to be conducted because there are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues, or reveal other concerns in relation with reproductive toxicity
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No studies on the test substance itself are available at the moment. An OECD 422 study is currently ongoing
According to item 8.7.2 in Column 1 of Annex IX of REACH (Regulation No 1907/2006), a 2-generation or extended one generation study is regarded a standard data requirement. In the ECHA Guidance on information requirements and chemical safety assessment; Chapter R.7a R7.6.6 a testing strategy for reproductive toxicity is described. It is stated that all substances needs to be subject to a thorough data review and that if sufficient data are available to permit a conclusion on reproductive and developmental toxicity potential, no further testing is required. This study is going to be considered to give sufficient information to permit the conclusion that the substance is not toxic to reproduction. Therefore, further testing for reproductive toxicity is considered not justified, taking into account animal welfare aspects.
Effects on developmental toxicity
Description of key information
No data on the test substance is available. Therefore data is derived from two structurally similar substances. For both substance a prenatal developmental toxicity study (OECD 414, GLP) is available in pregnant rats (Wistar and Sprague-Dawley) which were administered daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) at concentrations of 100, 300 and 1000 mg/kg bw. There was no evidence for toxicologically relevant adverse effects of the test substance on dams or pub development. The no observed adverse effect level (NOAEL) for maternal and prenatal developmental toxicity is 1000 mg/kg bw/d.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to chapter 13 for the category justification.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: No toxic effects at the highest dose tested
- Remarks on result:
- other: Read-across from CAS# 158318-67-3
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: overall effects
- Remarks on result:
- other: Read-across from CAS# 8013-07-8
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: Overall effects
- Remarks on result:
- other: Read-across from CAS# 8013-07-8
- Key result
- Abnormalities:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No toxic effects at the highest dose tested
- Remarks on result:
- other: Read-across from CAS# 158318-67-3
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- 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
Developmental study (CAS 158318-67-3)
In a prenatal developmental toxicity study, in accordance with GLP and OECD 414, the test substance was administered to pregnant Wistar rats daily by gavage from implantation to one day prior to the expected day of parturition (GD 6-19) to evaluate its potential maternal and prenatal developmental toxicity. Analyses confirmed the correctness of the prepared concentrations and the stability of the test substance in the vehicle. Generally, clinical observations including water consumption, food consumption and body weight gain revealed no toxicologically relevant difference between the animals receiving 100, 300 or 1000 mg/kg bw/d and controls. Most of the females (18 out of 25) of the high-dose group (1000 mg/kg bw/d) and one female of the mid-dose group (300 mg/kg bw/d) showed transient salivation during the treatment period. Salivation occurred in the respective animals only within the 2-hour examination interval (i.e. < 2h after treatment). It is considered to be treatment-related, likely as a result of the bad taste of the test substance/vehicle preparation or due to local irritation of the upper digestive tract. It is not considered to be a sign of systemic toxicity. No differences of toxicological relevance between the control and the treated groups (100, 300 or 1000 mg/kg bw/d) were determined for any reproductive parameters, such as conception rate, mean number of corpora lutea, mean number of implantations, as well as pre- and postimplantation loss. Similarly, no influence of the test substance on fetal weight and sex distribution of the fetuses was noted at any dose. Overall, there was no evidence for toxicologically relevant adverse effects of the test substance on fetal morphology at any dose. Under the conditions of this prenatal developmental toxicity study, the oral administration to pregnant Wistar rats from implantation to one day prior to the expected day of parturition (GD 6-19) at doses as high as 1000 mg/kg bw/d caused neither evidence of maternal nor developmental toxicity. In conclusion, the no observed adverse effect level (NOAEL) for maternal and prenatal developmental toxicity is 1000 mg/kg bw/d (BASF 2016)
Developmental study (CAS 8013-07-8)
The objective of the prenatal developmental toxicity study (OECD 414, GLP) was to evaluate the potential toxic effects of the test substance on the embryonic and fetal development when
administered daily by oral route (gavage) to pregnant female Sprague-Dawley rats during organogenesis (day 6 to day 15 of pregnancy inclusive).
Three groups of 25 mated female rats received daily by gavage the test substance at the dose levels of 100, 300 and 1000 mg/kg bw/day, from day 6 to day 15 of pregnancy inclusive. Simultaneously, a group of 25 mated females was given the vehicle Soybean oil (SBO) and acted as a control group. The day of mating was designated as day 0 of pregnancy. No clinical signs, no deaths and no abortions were noted in any of the groups. The mean food consumption and body weight gain of the females with completed pregnancy were similar in the control and treated groups. No treatment-related macroscopic changes were observed at necropsy of the females. The mean number of corpora lutea, implantation sites, live fetuses, the post-implantation loss and fetal body weight were similar in the control and treated groups. No extemal malformations were observed in fetuses of the control or treated groups. No treatment-related soft tissue anomalies or malformations were noted in fetuses of any group. No dose-related effects were noted on the incidence of the skeletal variations, anomalies or malformations.
In concusion, the test substance when administered daily by oral route (gavage) to pregnant female Sprague-Dawley rats during organogenesis at the dose levels of 100, 300 and 1000 mg/kg bw/day was well tolerated by the dams at all the dose levels and was neither embryotoxic or teratogenic (ETTEC 1993).
Justification for classification or non-classification
The available developmental toxicity studies from structural similar substances are reliable and suitable for classification purposes under Regulation 1272/2008. No adverse effects on fertility or development were observed. As a result, the substance is not considered to be classified for developmental toxicity under Regulation (EC) No. 1272/2008,as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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.