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Diss Factsheets
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EC number: 480-310-4 | CAS number: -
- 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:
- 14 March 2007 to 28 March 2007 (in-life phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC, Council Directive 67/548/EEC, Annex V, B.3 (1992) "Acute Toxicity (Dermal)"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA, OPPTS 870. 1200 (1998), "Acute Dermal Toxicity"
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000), including the most recent revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): MTDID 6675
- Substance type: Clear colourless liquid
- Physical state: liquid
- Analytical purity: Formulation tested is 30 % active ingredient in water
- Purity test date: 12/20/2005
- Lot/batch no.: 140499-19/10
- Expiration date of the lot/batch: 01 December 2008
- Storage condition of test material: At room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl:WI (outbred, SPF-Quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approximately 8 weeks old.
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: No data
- Housing: Individually housed in labeled Macrolon cages (MIII type, height 18 cm) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage enrichment.
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiaten GmbH, Soest, Germany ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days before treatement. During acclimation period animals were group housed in Macrolon cages (MIV type).
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3-23.6 degrees Celsius
- Humidity (%): 41-55%
- Air changes (per hr): 15 per hour.
- Photoperiod (12 hrs dark / 12 hrs light):
IN-LIFE DATES: From: 14 March 2007To: 28 March 2007
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Shaved area on the back of the animal approximately 25 square cm for males and 18 square cm for females
- % coverage: 10% of the total body surface
- Type of wrap if used: Test substance was held in contact with the skin with a dresssing, consisting of a surgical gauze patch (Surgy 1D), sucessively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was used for fixation of the bandages in females only
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed using tap water after 24 hours
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6689 mg/kg (5.766 mL/kg) body weight (2000 mg/kg of the active ingredient)
- Concentration (if solution): Formulation tested is 30% of the active ingredient in water - Duration of exposure:
- 24 hours
- Doses:
- One dose: 6689 mg/kg (5.766 mL/kg) body weight (2000 mg/kg of the active ingredient)
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At hours 0, 2, and 4 after treatment, and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occured during the study.
- Clinical signs:
- Hunched posture and chromodacryorrhoea were noted among the animals. Piloerection was noted in one female. The animals had recovered from the symptoms between days 2 and 5. General erythema and/or scales were seen in the treated skin-area of the animals during the observation period.
- Body weight:
- The changes noted in body weight gains in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the study, the acute dermal LD50 of the test article in rats was greater than 2000 mg/kg as the active ingredient.
- Executive summary:
The objective of this study was to evaluate the acute dermal toxicity of the test article in rats according to current OECD, EC, EPA and JMAFF guidelines. The test article was administered to Wistar rats by single dermal application (10% of total body surface, covered with an occlusive dressing) at a dose of 2000 mg/kg as the active ingredient for 24 hours. Clinical observations were performed daily and body weights recorded weekly. Necropsies were performed after terminal sacrifice on Day 15. No deaths occurred. Clinical signs included hunched posture, chromodacryorrhoea, piloerection and erythema and scales at the test site. Body weight gains were normal. No macroscopic abnormalities were observed at necropsy. Under the conditions of the study, the acute dermal LD50 of the test article in rats was greater than 2000 mg/kg as the active ingredient.
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