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EC number: 607-233-2 | CAS number: 2343-89-7
- 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
Repeated dose administration of the substance to rats by oral gavage, at dose levels of 0.75, 1.5 and 3 mg/kg bw/day, was well tolerated during the course of a combined repeat dose reproduction study (OECD 422) of at least 54 days duration. Based on the available results, whereby no reproductive toxicity was seen in either adults or the litter animals, the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 3 mg/kg bw/day.
The requirement for the EOGRTS and developmental toxicity studies are waived in accordance with REACH Annex XI, 3.2.(b). The substance is not incorporated in an article and for all relevant scenarios throughout the life cycle is used under strictly controlled conditions.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22/6/2015 to 6/5/2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test substance concentration in the dose samples was determined by HPLC with UV detection (HPLC-UV) using an external standard
- Duration of treatment / exposure:
- Up to 8 weeks (including a 2 week pre-pairing stage, pairing, gestation and early lactation for females)
- Frequency of treatment:
- Once daily
- Dose / conc.:
- 3 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1.5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 0.75 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 12 males and 12 females per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The dose selection was based on the outcome of a 14 day range finding study.
- Positive control:
- None
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:Immediately before dosing, up to 30 minutes post-dosing and one hour after dosing.
BODY WEIGHT: Yes
- Time schedule for examinations: Individual body weights will be recorded for males on Day 1 and then weekly until termination. Individual body weights will also be recorded at terminal kill. For females, individual body weights will be recorded on Day 1 and then weekly until pairing. During the pairing phase, females will be weighed daily until mating is confirmed. Mated females will be weighed on Day 0, 7, 14 and 20 post coitum and body weights for females which give birth will be recorded on Days 1 and 4 post partum. Body weights will also be recorded at terminal kill.
FOOD CONSUMPTION: Yes
- Time schedule: Male dietary intake will be recorded weekly prior to and after pairing. Female dietary intake will be recorded weekly prior to pairing. Food consumptions will not be performed during the pairing phase. Dietary intake for mated females will be recorded on Days 0-7, 7-14 and 14-20 post coitum. Food consumptions for females with live litters will be recorded between Days 1-4 post partum.
FOOD EFFICIENCY: Yes
- Time schedule: Weekly food conversion efficiency (body weight gain/food intake) will be calculated retrospectively for males and females prior to pairing, and for males after the pairing phase.
WATER CONSUMPTION: Yes
- Time schedule for examinations: Daily by visual inspection
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Day 42 (males) and Day 4 post partum (females).
- Animals fasted: No
- How many animals: 5 males and 5 females
- Parameters examined: Hemoglobin, Hematocrit, Erythrocyte count, Total leukocyte count, Differential leukocyte count, Erythrocyte indices (mean cell hemoglobin, mean cell volume, mean cell hemoglobin concentration), Prothrombin time, Activated partial thromboplastin time, Platelet count, Reticulocyte count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Day 42 (males) and Day 4 post partum (females).
- Animals fasted: No
- How many animals: 5 males and 5 females
- Parameters examined: Blood Urea, Total Protein, Albumin, Albumin/Globulin ratio (by calculation), Sodium, Potassium, Chloride, Calcium, Inorganic phosphorus, Creatinine, Alkaline phosphatase, Alanine aminotransferase, Aspartate aminotransferase, Glucose, Total cholesterol, Total bilirubin, Bile acids
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Before the first exposure to the test item and once weekly thereafter.
- Dose groups that were examined: All test and control
- Battery of functions tested: sensory activity / grip strength / motor activity - Oestrous cyclicity (parental animals):
- Not examined
- Sperm parameters (parental animals):
- Parameters examined in male parental generations: testis weight, epididymis weight, gross pathology, detailed qualitative histopathological examination of the testes, taking into account the tubular stages of the spermatogenic cycle.
- Postmortem examinations (parental animals):
- ORGAN WEIGHTS: Yes
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Postmortem examinations (offspring):
- GROSS NECROPSY: Yes
- Statistics:
- Where considered appropriate, quantitative data was subjected to statistical analysis to detect the significance of intergroup differences from control; statistical significance was achieved at a level of p<0.05. Statistical analysis was performed on the following parameters: Grip Strength, Motor Activity, Body Weight, Body Weight Change, Food Consumption during gestation and lactation, Pre-Coital Interval, Gestation Length, Litter Size, Litter Weight, Sex Ratio, Corpora Lutea, I plantation Sites, Implantation Losses, Viability Indices, Offspring Body Weight, Offspring Body Weight Change, Offspring Surface Righting, Hematology, Blood Chemistry, Absolute Organ Weights, Body Weight-Relative Organ Weights.
- Reproductive indices:
- Mating performance, fertility and gestation length
- Offspring viability indices:
- Litter size, sex ratio, viability, growth and development
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 3 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
- Key result
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 3 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: reproductive toxicity
- Reproductive effects observed:
- not specified
- Conclusions:
- Repeated dose administration of the substance to rats by oral gavage, at dose levels of 0.75, 1.5 and 3 mg/kg bw/day, was well tolerated during the course of a combined repeat dose reproduction study of at least 54 days duration. Based on the available results, whereby no reproductive toxicity was seen in either adults or the litter animals, the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 3 mg/kg bw/day (the highest dose employed).
- Executive summary:
In a subacute study the substance was administered to 12 rats/sex/dose by gavage at dose levels of 0, 0.75, 1.5 and 3 mg/kg bw/day for up to 8 weeks (including a 2 week pre-pairing stage, pairing, gestation and early lactation for females). There were no substance related effects in the parental generation in mortality, clinical signs, body weight, food and water consumption, haematology, clinical chemistry, behaviour, organ weights, or gross and histologic pathology, sperm measures and reproductive performance. There were no substance related effects in the F1 generation in mortality, clinical signs, body weight, or gross pathology. The reproductive NOEL is considered to be 3 mg/kg bw/day (highest dose employed).
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 3 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Sufficient to meet data requirements. The study is Klimisch 1.
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
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In the available OECD 422 study the substance gave rise to no reproductive toxicity. However the composition of the technical substance includes N,N-dimethylformamide (DMF) at levels of up to 1%. DMF is classified as a Reproductive toxicant, Category 1B and, since it may be present at levels above the classification threshold for mixtures (0.3%), the whole technical substance is classified as Reproductive toxicant, Category 1B. The composition also includes N,N-dimethylacetamide (DMA) which is also classified as a Reproductive toxicant, Category 1B however DMA is only present at levels below the specific classification threshold for mixtures (5%).
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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