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EC number: 220-103-6 | CAS number: 2628-17-3
- 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
Due to germ cell potential for mutagenicity in-vitro study, the substance has the potential of reproductive toxicity.
The following is the observations from the OECD422 range finding study.
The toxic changes in this fourteen day study are similar to those of phenol (EC 203-632-7 CAS 108-95-2), corrosive and chemical burns at contact site, transient CNS stimulation followed by CNS depression, coma, seizures, diarrhea, methemoglobinemia, etc. Reference should be made to Agency for Toxic Substances and Disease Registry (USA) Medical Management Guidelines for Phenol mmg115 2017.
The male animals who given teh low dose of 50mg/kg/bw were assessed as unlikley to be capable of reproduction. Due to the toxicity of the substance a toxicity ro reproduction study is going to be difficult to assess due to the other toxic effects of the substance on the animals
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- Range finding study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 September to 11 December 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- Range finding study
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- Study was a range finding study and was not conducted to full GLP requirements.
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
Maruzen Petrochemical Co.Ltd./ Bx 7831WJD
- Expiration date of the lot/batch:
- Purity test date:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Opaque airtight container at -30°C to -10°C
- Stability under test conditions:
Stable
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
OTHER SPECIFICS: - Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Commercial laboratory animal supplier.
- Females: nulliparous and non-pregnant: yes
- Age at study initiation:
7 weeks
- Weight at study initiation:
- Fasting period before study:
- Housing:
Barrier-system animal rooms
- Diet:
autoclaved pelleted diet ad libitum.
- Water:. ad libitum
- Acclimation period: 6 days
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
21 - 25°C
- Humidity (%):
40 - 70%
- Air changes (per hr):
10-15
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: From: To: - Route of administration:
- oral: gavage
- Vehicle:
- other: gum arabic
- Details on exposure:
- The animals were orally treated by gavage for 14 days daily with a syringe connected to a catheter at dosing volumes of 5 ml/Kg based on body weight
- Details on mating procedure:
- None, toxic effect meant mating would not take place
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- The animals were orally treated by gavage for 14 days daily with a syringe connected to a catheter at dosing volumes of 5 ml/Kg based on body weight
- Frequency of treatment:
- Daily
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Control
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Remarks:
- low dose
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- yes, concurrent no treatment
- Parental animals: Observations and examinations:
- Daily before and after dosing
- Postmortem examinations (parental animals):
- In males, salivation, prone position, colonic convulsions, decrease spontaneous locomotion, lacriamtion, incomplete eyelid opening were observed and all animals were dead in the 1000 mg/kg.bw group on day 1.
Salivation, prone position, colonic convulsions, decrease spontaneous locomotion, lacriamtion, incomplete eyelid opening were observed and all animals were dead in the 500 mg/kg.bw group on day 1.
Salivation, prone position, colonic convulsions, decrease spontaneous locomotion, lacriamtion, incomplete eyelid opening were observed and all animals were dead in the 200 mg/kg.bw group on day 1.
Decreased spontaneous locomotion and decreased respiratory rate were observed in one of the 50mg/kg group from day 2 to day 4.
In females, prone position, lateral position, colonic convulsion, decreased spontaneous locomotion, incomplete eyelid opening were observed and all animals died in the 1000 mg/kg group on day 1.
Salivation, lateral position,colonic convulsion, decreased spontaneous locomotion, incomplete eyelid opening were observed and all animals died in the 500 mg/kg group.
Decreased spontaneous locomotion, lacrimation, incomplete eyelid opening, decreased respiratory rate, sub-normal temperature were observed in the 200 mg/kg group on day 1.One animal in the 200 mg/kg group hada shuffling gate from day 2 and salivation, anorexia, decreased stool volume were observed on day 3 and this animal was euthanised on day 3. No abnormalities were observed in the 50 mg/kg group. - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- In males, salivation, prone position, colonic convulsions, decrease spontaneous locomotion, lacriamtion, incomplete eyelid opening were observed and all animals were dead in the 1000 mg/kg.bw group on day 1.
Salivation, prone position, colonic convulsions, decrease spontaneous locomotion, lacriamtion, incomplete eyelid opening were observed and all animals were dead in the 500 mg/kg.bw group on day 1.
Salivation, prone position, colonic convulsions, decrease spontaneous locomotion, lacriamtion, incomplete eyelid opening were observed and all animals were dead in the 200 mg/kg.bw group on day 1.
Decreased spontaneous locomotion and decreased respiratory rate were observed in one of the 50mg/kg group from day 2 to day 4.
In females, prone position, lateral position, colonic convulsion, decreased spontaneous locomotion, incomplete eyelid opening were observed and all animals died in the 1000 mg/kg group on day 1.
Salivation, lateral position,colonic convulsion, decreased spontaneous locomotion, incomplete eyelid opening were observed and all animals died in the 500 mg/kg group.
Decreased spontaneous locomotion, lacrimation, incomplete eyelid opening, decreased respiratory rate, sub-normal temperature were observed in the 200 mg/kg group on day 1.One animal in the 200 mg/kg group hada shuffling gate from day 2 and salivation, anorexia, decreased stool volume were observed on day 3 and this animal was euthanised on day 3. No abnormalities were observed in the 50 mg/kg group. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Mortality occured at 500 and 1000 mg/kg doses.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- For males decreased body weigh was observed in the 200 mg/kg group. No affect was observed on the 50mg/kg group.
In feamales, decreased body weigths were observed in 200 and 50 mg/kg groups. - Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, treatment-related
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- clinical signs
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- System:
- central nervous system
- Organ:
- spinal cord
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- yes
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- colon
- duodenum
- ileum
- intestine
- jejunum
- oesophagus
- oral cavity
- rectum
- stomach
- tongue
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- System:
- nervous system
- Organ:
- forebrain
- neurons
- spinal cord
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- System:
- urinary
- Organ:
- bladder
- kidney
- ureter
- urethra
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 0 mg/kg bw/day (actual dose received)
- Based on:
- test mat. (total fraction)
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- gross pathology
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- other: Not tested
- Effect level:
- > 0 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- other: not tested
- Effect level:
- > 0 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects occurring together with other toxic effects, but not as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- yes
- Relevant for humans:
- yes
- Conclusions:
- The toxic changes in this fourteen day study are similar to those of phenol (EC 203-632-7 CAS 108-95-2), corrosive and chemical burns at contact site, transient CNS stimulation followed by CNS depression, coma, seizures, diarrhea, methemoglobinemia, etc. Reference should be made to Agency for Toxic Substances and Disease Registry (USA) Medical Management Guidelines for Phenol mmg115 2017.
Due to the toxic effects coninuation of the study will only lead to unecessary suffering of more animals
Reference
Male animals were not capable of reproduction at the low dose of 50mg/kg/bw
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Justification for classification or non-classification
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.