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Diss Factsheets
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EC number: 476-700-9 | CAS number: 15365-14-7
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 May 2012 to 27 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Physical state: solid
- Appearance: black
- Storage condition of test material: room temperature in the dark in sealed bags
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 10 weeks (males); 12 - 14 weeks (females)
- Weight at study initiation: 240 - 262 g (amles); 206-223 g (females)
- Fasting period before study: no data
- Housing: animals were individually housed in IVC cages, type III H furnished with Altromin saw fibre bedding
- Diet: ALTROMIN 1324 maintenance diet for rats and mice (ad libitum)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Vehicle:
TEST SITE
- Area of exposure: back
- % coverage: ca 10 % of body surface
- Type of wrap if used: semiocclusive gauze + adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: at end of exposure
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Concentration (if solution): 100 %
- Constant volume or concentration used: yes
- For solids, paste formed: no, the test material was used as supplied. In order to ensure good skin contact it was moistened with aqua ad injectionem. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed on days 1 (prior to application), 8 and 15. A clinical examination was made several time of the day of dosing; thereafter, animals were observed daily.
- Necropsy of survivors performed: yes, macroscopic
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the study.
- Clinical signs:
- other: No signs of toxicity were noted during the study.
- Gross pathology:
- Male 21 had a yellow spot on the epididymides. Male 22 had granulated Peyer' patches. these were considered incidental findings and were not considered to be related to treatment with the test material. No specific gross pathological changes were recorded for any other animals.
- Other findings:
- No erythema or oedema was noted on any animal during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the acute dermal LD50 of the test material was determined to be in excess of 2000 mg/kg bw.
- Executive summary:
The acute dermal toxicity of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 402, EU Method B.3 and EPA OPPTS 870.1200.
During the study, five male and five female rats received semi-occlusive dermal applications of 2000 mg/kg bw of test material. The exposure duration was 24 hours. The animals were observed for mortality, clinical signs, body weight changes and local reactions for 14 days after which time they were sacrificed and subjected to gross necropsy.
Under the conditions of the study, none of the animals died, no clinical signs were observed and the body weight development of all male and female animals was within the expected range. Male 21 had a yellow spot on the epididymides. Male 22 had granulated Peyer' patches. These were considered incidental findings and were not considered to be related to treatment with the test material. No specific gross pathological changes were recorded for any other animals. No erythema or oedema was noted on any animal during the study.
It was therefore concluded that the acute dermal LD50 of the test material is in excess of 2000 mg/kg bw.
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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