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Diss Factsheets
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EC number: 920-912-0 | 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:
- 03.06.2008-17.06.2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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:
- fixed dose procedure
- Limit test:
- yes
Test material
- Test material form:
- solid
- Details on test material:
- • Sponsor’s identification: LCEO8O9O
• Container : plastic fiask (n=1)
• Quantity : 592.2 g (container + contents)
• Batch n° :0731900052
• Production date: 15 November 2007
• CASNo:
It was identified under the code number: PH-08/0228.
• Date received : 22 May 2008
• Form: granular
• Colour : white
• Storage : room temperature
• Re-test date: 14 November 2010
• Purity: -
Constituent 1
- Specific details on test material used for the study:
- • Sponsor’s identification: LCEO8O9O
• Container : plastic fiask (n=1)
• Quantity : 592.2 g (container + contents)
• Batch n° :0731900052
• Production date: 15 November 2007
• CASNo:
It was identified under the code number: PH-08/0228.
• Date received : 22 May 2008
• Form: granular
• Colour : white
• Storage : room temperature
• Re-test date: 14 November 2010
• Purity: -
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Twenty Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle
— France), were used alter an acclimatisation period of at least five days. At the beginning of the study,
thc animais of the treated group weighed between 216 g and 241 g (males) and between 204 g and
216 g (females) and were 7-8 weeks old.
Group 1 (control):
5 male rats and 5 female rats
Rm0722 to Rm0726 R10727 to Rf073 I
Group 2 (treate4jj
5 male rats and 5 female rats
Rm0792 to Rm0796 Rf0797 to Rf0801
Housing
During the treatment, the animais were kept in individual cage. At D3, the animais were put into their cage by 2 or 3, The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steei mesh lid. Each cage contains sawdust bedding which vas cbanged at least 2 times a week. Each cage was installcd in conventionai air conditioned animal husbandry; the environmental conditions were:
- temperature : between 19°C and 23°C
- relative hnmidity : between 41% and 69%
- lighting thne: 12 hours daily
- rate of air exchange: at Least ten changes per hour
Food and drink
Drinking watcr (tap-water ibm public distribution system) and foodstuff were supp lied freely.
Microbiological and chemicai analyses of the water were carried out once every six months by the
Institut Européen de l’Environnement de Bordeaux (I.E.E.B.).
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- Animais from Group 2 reeeived by topicai application, under porous gauze dressing, an effective dose of 2000 mglkg body weight of LCEO8O9O, previously heated at 50°C, diluted in liquid paraffin and administered under a volume of 10 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed.
Animals from Group 1 received in the same experimental conditions the vehicle (liquid paraffm) under a volume of 2.32 mL/kg body veight. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- No systemic clinical signs related to the administration of the test item were observed.
A well defined erythema was noted, on the treated area, 24 hours after the test item administration in all treated animals. These reactions were associated with a very slight oedema in four female treated animals. The treated areas have recovered a normal aspect between D3 and D6. - Body weight:
- Forty eight hours after the test item administration, it was noted a very slight decrease of the body weight (-2% in the treated male rats and -4% in the treated female rats). Then the body weight evolution of the animais remained normal, similar between treated and control animals.
- 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:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test hem LCE08090 is higher than 2000 mg/kg body weight by dermal route in the rat.
According to the criteria for classjfication, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test hem LCE08090 must not be classified.
No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal word and hazard statement are required. - Executive summary:
The test item LCE08090 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. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. guideline. n° 402 dated February 24th, 1987 and the test method B.3 of the directive, n° 92/69/EEC.
No mortality occurred during the study.
No systemic clinical signs related to the administration of the test item were observed. A well defined erythema was noted, on the treated area, 24 hours after the test item administration in all treated animals.
These reactions were associated with a very slight oedema in four female treated animals. The treated areas have reeovered a normal aspect between D3 and D6. Forty eight hours after the test item administration, it was noted a very slight decrease of the body weight (-2% in the treated male rats and -4% in the treated female rats). Then the body weight evolution of the animals remained normal, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the test item LCE08090 is 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 the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item LCE08090 must not be classiflied. No symbol and risk phrase are required. In accordance with the Globally Harmonized System (COM(2007)355 finaI), the test item must net be classified in category 4. No signal word and hazard statement are 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.
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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