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Diss Factsheets
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EC number: 604-638-6 | CAS number: 148520-82-5
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid
Test animals
- Species:
- rat
- Strain:
- other: CFY (remote Sprague Dawley origin)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Females (if applicable) nulliparous and non-pregnant: No data
- Age at study initiation: approximately six to eight weeks of age
- Weight at study initiation: 210 to 239 g prior to dosing on day 1
- Fasting period before study: No data
- Housing: individual metal cages with wire mesh floors; Each animal was identified by cage number and ear punching- Diet (e.g. ad libitum): ad libitum, standard diet
- Water (e.g. ad libitum): ad libitum, water
- Acclimation period:a period of 15 days prior to study initiation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: No data
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Test material was a yellow viscous liquid and was applied to an area clipped with electric clippers (approximately 10% of the area) on the backs of 10 rats
- % coverage: No data
- Type of wrap if used: The areas were covered with gauze held in place with an impermeable plastic dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dressings were carefully removed and the treated area of skin washed in warm water and blotted dry with absorbent paper.
- Time after start of exposure: At the end of 24 hours
- Duration of exposure:
- 24 hrs
- Doses:
- 2000 mg/kg (undiluted)
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and then at frequent intervals for the remainder of day 1. On subsequent days the animals were observed once in the morning and again at the end of the experimental day.
- Necropsy of survivors performed: yes
- Other examinations performed: The treated areas were examined daily for signs of dermal irritation and assessed according to the standard scoring system for erythema, eschar and oedema. All animals were observed for 14 days after dosing. On day 15 all animals were sacrificed and given a macroscopic post-mortem examination of internal organs.clinical signs, body weight,organ weights, histopathology, other:
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: undiluted
- Mortality:
- No mortality was observed exposure to 2000 mg/kg of the undiluted test material.
- Clinical signs:
- There were no signs of systemic reaction. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressings. These reactions were unresolved before progressive hardening of the skin was first detected on day 4. All test sites were entirely covered by scab formation from day 7. Sloughing from the scabbed skin began at various times between day 7 and day 12 and was completed before test termination.
- Body weight:
- Low bodyweight gains or loss of bodyweight were recorded for one male and three female rats on day 8. Two of the same females and a third female rat also showed low bodyweight gains between days 8 and 15.
- Gross pathology:
- All terminal autopsy findings were normal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal dermal dose LD50 was found to be greater than 2000 mg/kg. Therefore, the test substance is considered not to be classified according to the CLP Regulation.
- Executive summary:
The clipped skin on the backs of five male and five female rats were exposed to the test material under an occlusive dressing for 24 hours and observed for another 14 days. Results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg.
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