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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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
- Study period:
- from 26 June to 10 July 2012
- Reliability:
- 1 (reliable without restriction)
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
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: orange fluid gel
- Details on test material:
- Lot/Batch: No.1645
Purity: 100%
Test item was considered to be stable in test conditions
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 5 males and 5 females
Age: 7 and 8 weeks for males and females, respectively
Weight at dosing: 220 - 238 g (males) and 188 - 205 g (females)
Acclimation period: at least 5 days
Diet: M2-rat/mouse maintenance
Water: tap-water from public distribution system (Microbiological and chemical analyses of the water were carried out once every six months by IPL, Santé, Environnement Durables - Atlantique, Bordeaux)
Housing: Individually during treatment (24 hours), then 5 rats / cage (clear polycarbonate cages with stainless steel)
Temperature: 19-25°C
Humidity: 30 - 70%
Air changes: fifteen changes per hour
Photoperiod: 12 hours continous light (07:00 to 19:00) and 12 hours darkness
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping. At least 10 per cent of the body surface area was clear for the application of the test item.
Then, rats received the test item by topical application, under porous gauze dressing. - Duration of exposure:
- After 24-hours exposure period, the gauze dressings were removed and the treated area was rinsed with distilled water.
- Doses:
- An effective dose of 2000 mg/kg body weight of CAE administered under a volume of 2.19 mL/kg body weight (corresponding to 2 g/kg b.w. according to the calculated density).
- No. of animals per sex per dose:
- Limit-test: 10 rats treated with a single dose of 2000 mg/kg b.w.
- Control animals:
- other: control historical data
- Details on study design:
- Mortality, clinical signs and skin examination were recorded daily for the duration of the study (14 days).
Individual body weights were measured and recorded on days 0 (dosing), 2, 7 and 14. On day 14, all surviving animals were sacrificed and all animals were necropsied for gross pathological changes. - Statistics:
- None.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No systemic clinical signs related to the administration of the test item were observed. Erythema was noted from 48 hours post-dose in three females and was totally reversible on day 4. Dryness was noted from day 3 in three females and was totally reversible on day 6.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- In conclusion, the LD50 of the test item CAE was higher than 2000 mg/kg body weight by dermal route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with EEC Directives 67/548, 2001/59 and 99/45, the test item CAE must not be classified. No symbol or risk phrase is required.
In accordance with Regulation EC No.1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified. No signal word or hazard statement is required. - Executive summary:
In an acute dermal toxicity study, the test item CAE was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight (limit test) under an occlusive patch, according to the official method as defined in O.E.C.D. guideline No.402 and in test method B.3 of Council Regulation No.440/2008.
All animals were observed for 14 days. Then surviving animals were sacrificed and a necropsy was conducted. Body weights were recorded on days 0 (dosing), 2, 7, 14.
No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed. Erythema was noted from 48 hours post-dose in three females and was totally reversible on day 4. Dryness was noted from day 3 in three females and was totally reversible on day 6.
The body weight evolution of the animals remained comparable between treated and control animals throughout the study.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50of the test item CAE was higher than 2000 mg/kg body weight by dermal route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with EEC Directives 67/548, 2001/59 and 99/45, the test item CAE must not be classified. No symbol or risk phrase is required.
In accordance with Regulation EC No.1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified. No signal word or hazard statement is required.
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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