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EC number: 217-682-2 | CAS number: 1929-82-4
- 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:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Authorative secondary source with limited information provided. Original study report was not available.
- Principles of method if other than guideline:
- Secondary literature source no data about the method was available.
- GLP compliance:
- not specified
- Species:
- rat
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Dose descriptor:
- NOAEL
- Effect level:
- 5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOAEL
- Remarks:
- Reproduction
- Effect level:
- 75
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Remarks:
- Reproduction
- Effect level:
- > 75 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 75 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 75 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Authorative secondary source with limited information on methodology provided only. Original study report was not available.
Additional information
Sole reference available.
Effects on developmental toxicity
Description of key information
In a teratogenicity study on rats and rabbits using the oral route of administration (Berdasco et al., 1998) the following dose decriptors were derived: for rats the NOAEL for maternal toxicity was determined to be 15 mg/kg bw/day, while the NOAEL for teratogenicity and fetotoxicity were determined to be 50 mg/kg bw/day. For rabbits the NOAEL for maternal toxicity was determined to be 10 mg/kg bw/day, the NOAEL for teratogenicity was determined to be 30 mg/kg bw/day and the NOAEL for fetotoxicity was determined to be 10 mg/kg/bw/day.
Supporting studies:
The US-EPA RED (2005) document cites the results of the results of a two-generation reproduction study in fischer 344 Rats. Here the NOAEL for parental toxicity was cited to be 5 mg/kg bw/day. The NOAEL for reproduction toxicity was cited to be 75 mg/kg bw/day. The NOAEL for the offspring was cited to be 20 mg/kg bw/day.
The US-EPA RED (2005) document cites the results of a further developmental toxicity study in rats with test item. Here the NOAEL was cited to be 50 mg/kg bw/day.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Peer reviewed literature. The study is regarded as reliable with restrictions because it was not conducted in compliance with GLP regulation but data are comprehensive and scientifically acceptable.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- other: rats and rabbits
- Strain:
- other: Rats: Fischer 344; rabbits: NZ White rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rats: Charles River Breeding Laboratories, I'nc Kingston, NY; rabbits: Hazelton-Dutchland Inc., Denver, PA.
- Weight at study initiation: Rats: 165-225 g; rabbits: 3.5 -4.5 kg
- Housing: Animals were housed singly in wire-bottom cages
- Diet: not specified, provided ad libitum
- Water: municipal driking water, provided ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- - Dose volume: rats 4 mL; rabbits 1 mL
- Justification for use and choice of vehicle: solubilty of test item - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Solutions of test item were analyzed for stability.
- Details on mating procedure:
- - Impregnation procedure: Rats were mated in-house, rabbits were artificial inseminated.
- Proof of pregnancy: rats: presence of sperm in vaginal smear - Duration of treatment / exposure:
- Rats were dosed from day 6 to day 15 of gestation.
Rabbits were dosed from day 6 to day 18 of gestation. - Frequency of treatment:
- daily
- Duration of test:
- Rats: until c-section on day 21
Rabbits: until c-section on day 28 - Remarks:
- Doses / Concentrations:
Rabbits: 0, 3, 10, 30 mg/kw bw/day
Basis:
actual ingested - Remarks:
- Doses / Concentrations:
Rats: 0, 5, 15, 50 mg/kw bw/day
Basis:
actual ingested - No. of animals per sex per dose:
- Rats: 29-30 animals per dose group
Rabbits: 25 animals per dose group - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: For the rats dose levels chosen were based on the results of a preliminary study with oral test item administration of 15, 50 and 100 mg/kg bw/day. For the rabits dose levels chosen were based on the results of a preliminary study with oral test item administration of 30, 100 and 200 mg/kg bw/day.
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule: Rats: On day 0, 6-16 and 21 of gestation; rabbits: on day 6-19 and 28 of gestation
FOOD AND WATER CONSUMPTION: Yes, but for rats only in three day intervals.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21 for rats and day 28 for rabbits
- Organs examined: Liver - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes, half per litter
- Skeletal examinations: Yes, all per litter
- Head examinations: Yes, all per litter - Statistics:
- Analyses of body weights and absolute and relative organ weights were performed using parametric or nonparametric ANOVA followed by either Dunnett's test or the Wilcoxon Rank-Sum test with Bonferroni's correction. Descriptive statistics (means and standard deviations) were calculated for food and water consumption. Evaluation of the frequency of preimplantation loss, resorptions among litters and the fetal population, and fetal alterations was performed by a censored Wilcoxon test with Bonferroni's correction, in which the litter was considered the experimental unit. Thee number of corpora lutea, implants, and litter size was analyzed using a nonparametric ANOV A followed by the Wilcoxon Rank-Sum lest with Bonferroni's correction. Pregnancy rate was analyzed
by the Fisher exact probability test. The fetal sex ratio was analyzed by a binomial distribution test. The nominal level used for statistical evaluation was 0.05. - Indices:
- no data
- Historical control data:
- no data
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Rats: Administration of test item at 50 mg/kg bw/day to pregnant rats resulted in slight maternal toxicity which was characterized by slight histopathologic changes in the livers of pregnant rats. No adverse effects were noted in the lower treatment groups.
Rabbits: Administration of test item at 30 mg/kg bw/day to pregnant rabbits resulted in a decreased weight gain during the treatment period and increased absolute and relative liver weight. No adverse effects were noted in the lower treatment groups. - Dose descriptor:
- NOAEL
- Remarks:
- rats
- Effect level:
- 15 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Remarks:
- rabbits
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
For the rats, fetal examination revealed no evidence of fetotoxicity or teratogenicity among rats at dose levels up to 50 mg/kg/day.
For the rabbits, an increased incidence of crooked hyoid bone among fetal rabbits in the 30 mg/kg/day dose group was considered indicative of slight fetotoxicity but not teratogemcity. - Dose descriptor:
- NOAEL
- Remarks:
- rats
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Remarks:
- rats
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Dose descriptor:
- NOAEL
- Remarks:
- rabbits
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Remarks:
- rabbits
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
- Quality of whole database:
- Peer reviewed literature. The study was not conducted in compliance with GLP regulation but data are comprehensive and scientifically acceptable.
Additional information
Key study:
Berdasco et al. (1988) evaluated the teratogenicity of the test item using pregnant Fischer 344 rats and New Zealand White rabbits. The study was conducted in a similar manner to OECD guideline 414. In this study the test item was orally administered (gavage) at 0, 5, 15, or 50 mg/kg bw/day on gestation days 6 through 15 for rats and at 0, 3, 10, or 30 mg/kg bw/day on gestation days 6 through 18 for rabbits. In rats, 50 mg/kg bw/day produced slight histopathologic changes in the livers of pregnant females. Fetal examination revealed no evidence of fetotoxicity or teratogenicity among rats at dose levels up to 50 mg/kg/day. Among rabbits a significant depression in maternal weight gain and increased absolute and relative liver weights were observed at 30 mg/kg/day. An increased incidence of crooked hyoid bone among fetal rabbits in the 30 mg/kg/day dose group was considered indicative of fetotoxicity but not teratogenicity. Accordingly, for rats the NOAEL for maternal toxicity was determined to be 15 mg/kg bw/day, while the NOAEL for teratogenicity and fetotoxicity were determined to be 50 mg/kg bw/day. For rabbits the NOAEL for maternal toxicity was determined to be 10 mg/kg bw/day, the NOAEL for teratogenicity was determined to be 30 mg/kg bw/day and the NOAEL for fetotoxicity was determined to be 10 mg/kg/bw/day.
Supporting studies:
The US-EPA RED (2005) document cites the results of the results of a two-generation reproduction study in fischer 344 Rats. Here the NOAEL for parental toxicity was cited to be 5 mg/kg bw/day.
The NOAEL for reproduction toxicity was cited to be 75 mg/kg bw/day. The NOAEL for the offspring was cited to be 20 mg/kg bw/day. The US-EPA RED (2005) document cites the results of a further developmental toxicity study in rats with test item. Here the NOAEL was cited to be 50 mg/kg bw/day.
Justification for selection of Effect on developmental toxicity: via oral route:
Study with highest information content.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available information are considered reliable and suitable for
classification purposes under Directive 67/548/EEC. As a result
and according to the harmonised Annex I classification the substance is
not considered to be classified for toxicity to reproduction under
Directive 67/548/EEC, as amended for the 31st time in Directive
2009/2/EG.
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
Additional information
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