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EC number: 600-775-0 | CAS number: 1067676-04-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Single dose; 14 day observation
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Performed to guidelines, 2018
Material tested included butanol, monoethylene glycol and water at ca 50% actives. The solvents and water were not possible to remove under conditions that would not otherwise cause stability problems. The solvents and water are not stabilisers, but the temperatures needed to remove cause instability.
Freeze drying is not possible in view of the solvents, water and amines in the substance forming azoetropes.
In view of the mortality seen in three out of four animals at the top dose, a reduced dose of 300 mg/kg of the material supplied was tested. It is accepted that for REACH, a dose of 600 mg/kg (300 mg/kg actives) should have been tested, but as the data is also needed for US regulatory purposes and for classification of the material as supplied, the dose levels were aimed at the material as supplied.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane and ethylenediamine, reaction products with carbon disulphide, potassium salts
- EC Number:
- 600-775-0
- Cas Number:
- 1067676-04-3
- IUPAC Name:
- Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane and ethylenediamine, reaction products with carbon disulphide, potassium salts
- Test material form:
- liquid
- Details on test material:
- Technical grade, CA 50% in water
Constituent 1
- Specific details on test material used for the study:
- Batch: Lot#102-17 filtered
Purity: Not a neat substance the average activity is 48.66%
Physical state / Appearance orange liquid
Expiry Date: 01 May 2019
Storage Conditions: room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the mean body weight of any previously treated animals
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- For the 300 mg/kg dose level the test item was freshly prepared as required, as a solution in distilled water.
For the 2000 mg/kg dose level the test item was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. - Doses:
- Initial sightighting 300 mg/kg and 2000 mg/kg on material as supplied (ca 150 and 1000 mg/kg actives)
Main dose 2000 mg/kg (1000 mg/kg acitves), but mortality noted in this group, even though animal used in sighting study survived.
Further treatment of 300 mg/kg (ca 150 mg/kg actives) to confirm no adverse effect level - No. of animals per sex per dose:
- Four females in main groups.
- Control animals:
- no
Results and discussion
- Preliminary study:
- The single females treated with 300 and 2000 mg/kg survived (150 and 1000 mg/kg actives) and at 2000 mg/kg, minimal clincial signs seen (hunched posture for 2 hours post dosing)
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- ca. 1 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: Estimated
- Remarks:
- Two out of 5 animals survived dose of 2000 mg/kg material supplied (ca 1000 mg/kg actives)
- Sex:
- female
- Dose descriptor:
- other: NOAEL
- Effect level:
- ca. 150 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: Five out of five animals showed no adverse effects (other than short term hunched posture) at 150 mg/kg actives (300 mg/kg as supplied)
- Mortality:
- Three animals treated at a dose level of 2000 mg/kg were found dead on Day 0. There were no deaths noted at a dose level of 300 mg/kg.
Deaths were within 2 hours of treatment. - Clinical signs:
- other: Signs of systemic toxicity noted in the animals that were found dead during the study were hunched posture, ataxia, lethargy, loss of righting reflex, decreased respiratory rate and labored respiration. Signs of systemic toxicity noted in the surviving an
- Gross pathology:
- Abnormally red lungs, dark liver, dark kidneys and reddened gastric mucosa were noted at necropsy of animals treated at a dose level of 2000 mg/kg that died during the study. There were no abnormalities noted at necropsy of the surviving animals treated at a dose level of 2000 mg/kg. There were no abnormalities noted at necropsy of animals treated at a dose level of 300 mg/kg.
- Other findings:
- No other significant findings
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg (150 - 1000 mg/kg expressed as actives).
Material tested included butanol, monoethylene glycol and water at ca 50% actives. The solvents and water were not possible to remove under conditions that would not otherwise cause stability problems. The solvents and water are not stabilisers, but the temperatures needed to remove cause instability.
Freeze drying is not possible in view of the solvents, water and amines in the substance forming azoetropes.
In view of the mortality seen in three out of four animals at the top dose, a reduced dose of 300 mg/kg of the material supplied was tested. It is accepted that for REACH, a dose of 600 mg/kg (300 mg/kg actives) should have been tested, but as the data is also needed for US regulatory purposes and for classification of the material as supplied, the dose levels were aimed at the material as supplied.
The survival of 2 of the 5 animals that received the top dose of 1000 mg/kg actives (2000 mg/kg as supplied) and the absence of any effect at 150 mg/kg actives (300 mg/kg as supplied) would suggest GHS Acute Tox 4. Testing another group at 300 mg/kg actives is not justifed.
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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