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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Description of key information
The substance was tested in a reliable OECD 422 study using dose levels of 0.75, 1.5 and 3 mg/kg/day. The main study demonstrated no adverse effects at any dose level and no target organ was identified. The NOEL is 3 mg/kg/day.
The dose selection for the main study was based on a 14 day range finding study. In the study dose levels of 0, 3, 5 and 10 mg/kg/day were used which resulted in a reduction in overall mean body weight gain in all treated dose groups. Based on these results, dose levels of 10 or 5 mg/kg bw/day were considered to be too high for repeat dosing in an OECD 422 study. A dose level of 3 mg/kg bw/day was considered to be suitable as the high dose level for the main OECD 422 study.
The requirement for the 90 day subchronic study is 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.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: 14 day dose ranging study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is a dose ranging study only. It was not conducted to a specific guideline however was conducted to GLP.
- Principles of method if other than guideline:
- 3 males and 3 females were dosed for 14 days
- 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:
- no
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- Once daily
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 3 mg/kg bw/day (nominal)
- Dose / conc.:
- 5 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- yes, concurrent vehicle
- Positive control:
- None
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
FOOD EFFICIENCY: Yes
WATER CONSUMPTION: Yes
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY:No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- ORGAN WEIGHTS: No
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN: At all dose levels, overall mean body weight gains for males were lower than controls but without any dose-relationship. At 10 mg/kg/day, this was mainly due to lower body weight gain during the first week of the treatment period with subsequent improvement evident during the second week. At 3 and 5 mg/kg/day, lower overall body weight gains were also mainly due to reduced body weight gains or body weight losses during the first week of the dosing period; individual males from these dose groups also showed body weight losses during the second week which further contributed to the lower overall body weight gains for these dose groups. For treated females, overall mean body weight gains were lower than controls with 10 mg/kg/day females showing an actual body weight loss over the treatment period. At 10 mg/kg/day, reduced body weight gains or actual body weight losses were apparent throughout the dosing period whilst for females from 3 or 5 mg/kg bw/day, it was mainly due to the initial effect over Days 1 to 4 of dosing.
- Critical effects observed:
- not specified
- Conclusions:
- The oral administration of 3, 5 and 10 mg/kg bw/day resulted in a reduction in body weight gains in animals of either sex. Based on these results, dose levels of 10 or 5 mg/kg bw/day were considered to be too high for repeat dosing in an OECD 422 study. A dose level of 3 mg/kg bw/day was considered to be suitable as a high dose level for the OECD 422 study.
- Endpoint:
- short-term repeated dose toxicity: oral
- 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
- Observations and examinations performed and frequency:
- 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 - Sacrifice and pathology:
- ORGAN WEIGHTS: Yes
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: 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.
- 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
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 3 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No specific target organ or systemic toxicity was seen.
- Key result
- Critical effects observed:
- no
- Conclusions:
- No changes were observed in male and female rats following dosing with the substance, when administered by oral gavage for 54 consecutive days at dosages of 0.75, 1.5 and 3 mg/kg bw/day. A 'No Observed Effect Level’ (NOEL) for systemic 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 mortality, clinical signs, body weight, food and water consumption, haematology, clinical chemistry, behaviour, organ weights, or gross and histologic pathology. The NOEL is considered to be 3 mg/kg bw/day (highest dose employed).
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- 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.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the data from a 14 day range finding study and an OECD 422 screening study, the substance has the potential to produce severe toxicity following repeated exposure. Given the range of dose levels giving rise to adverse effects, the substance is classified as a Specific Target Organ Toxicant, Category 1 (H372).
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.