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Diss Factsheets
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EC number: - | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
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
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Methods for the Determination of Toxicity Method B.3 Directive 92/69/EEC
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- GLP compliance:
- yes
- Test type:
- other: Single-dose acute dermal
- Limit test:
- yes
Test material
- Details on test material:
- - Purity: 28 wt%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approximately 9 weeks
- Weight at study initiation: Range of 299 – 340 grams for males; range of 202 – 235 grams for females.
- Fasting period before study: Not reported
- Housing: Singly in polycarbonate pans that contained bedding with enrichment (i.e., Shepherd's™ Cob + PLUS™).
- Diet (e.g. ad libitum): PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Humidity (%): 30-70%
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area.
- % coverage: approximately 5 cm x 7.4 cm (approximately 37 square centimetres), approximately 10% of the body surface.
- Type of wrap if used: The test substance was covered with a 2-ply gauze pad. The rats were then wrapped with stretch gauze bandage and self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were washed with warm water, and the skin was dried.
- Time after start of exposure: After 24 hours of exposure to the test substance.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg of body weight of the test substance. The dose for each animal was corrected for purity.
- Constant volume or concentration used: yes - Duration of exposure:
- Animals were exposed to the test substance for 24 hours. Animals were observed for 14 days.
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 5 animals per sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Body Weights – Individual body weights were recorded prior to test substance application (test day 0) and on test days 7 and 14.
Observations – Rats were observed for clinical signs of toxicity and dermal response following test substance removal. Observations for mortality and signs of illness, injury, and abnormal behaviour were made daily throughout the study. Observations for clinical signs of toxicity and dermal irritation were made daily throughout the study (weekends excluded for dermal irritation) for 14 days.
- Necropsy of survivors performed: Yes.
- Other examinations performed: Pathology examination, grossly observable evidence of organ or tissue damage. - Statistics:
- No.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortalities occurred. All animals survived exposure to the test substance.
- Clinical signs:
- No clinical signs of systemic toxicity were observed. No erythema or oedema was observed on the test site of any rat. Hyperkeratosis was observed on the test site of 3 female rats on test days 6 and 7, and epidermal scaling was observed on the test site of 2 of these rats on test day 8.
- Body weight:
- No biologically important body weight losses were observed.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC
- Conclusions:
- The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 (rats) > 5000 mg/kg - Executive summary:
An acute dermal toxicity test was conducted with rats to determine the potential for the test substance to produce toxicity from a single topical application. A single dose of five thousand milligrams of the test substance per kilogram of body weight was applied to the skin of 5 male and 5 female rats. The dose for all rats was corrected for the test substance purity. The application site was covered with a semi-occlusive dressing for 24 hours, after which the test substance was removed, and the rats observed for clinical signs of toxicity and dermal response. Observations for mortality and signs of illness, injury, and abnormal behaviour were made daily throughout the study. Observations for clinical signs of toxicity and dermal irritation were made daily throughout the study (weekends excluded for dermal irritation) for 14 days. Individual body weights were recorded prior to test substance application (test day 0) and on test days 7 and 14. Necropsies were performed on all animals at terminal sacrifice. No deaths occurred. The rats exhibited no clinical signs of systemic toxicity or biologically important body weight losses during the study. No erythema or oedema was observed on the test site of any rat. Hyperkeratosis was observed on the test site of 3 female rats on test days 6 and 7, and epidermal scaling was observed on the test site of 2 of these rats on test day 8. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the dermal LD50 for the test substance corrected for purity was greater than 5000 mg/kg for male and female rats.
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.
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