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EC number: 800-036-4 | CAS number: 1422423-64-0
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January, from 14th to 28th, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- December 17th, 2001
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Set Retard Plus
- IUPAC Name:
- Set Retard Plus
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy breeding, S. Pietro al Natisone (UD).
- Weight at study initiation: 192 - 202 g.
- Housing: transparent polycarbonate cages (425 x 266 x 180 mm); animals were housed 5 per cage.
- Fasting period before study: test animals were fasted overnight before the beginning of the test. 4 hours after exposure, regular pellet diet was provided.
- Diet: pellet diet from Harlan Italy.
- Water: purified water, ad libitum.
- Quarantine: 5 days.
- Health check: the animals were subjected to a veterinary examination to ensure their suitability for the study.
ENVIRONMENTAL CONDITIONS
- Illumination: fluorescent light lamp.
- Photoperiod: 12 hours light and 12 hours dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: weekly weight control. Mortality, main organic functions evaluation, skin evaluation, mucous evaluation mobility and sensitivity evaluation were conducted at 30 min, at 2 and 4 hours and after 1, 2, 5, 6, 7, 8, 9, 12, 13 and 14 days of exposure.
- Necropsy of survivors performed: at the end of the study period.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed
- Clinical signs:
- During the test, all animals showed piloerection 4 hours after the exposure, tucked up abdomen 24 hours after the exposure.Those symptoms disappeared in two animals after 7 days from the test start, in three animals after 8 days from the test start.
- Body weight:
- A weight increase was observed in all test animals.
- Other findings:
- Two animals showed a moderate mucous enteritis and one animal showed a slight mucous enteritis.
Any other information on results incl. tables
Weight increase
Female N. | Weighed gain (g) |
1 | 13 |
2 | 10 |
3 | 10 |
4 | 16 |
5 | 16 |
Body weight of treated animals, registered at the test start, after 7 and after 14 days of treatment.
Female N. | Start (g) | Mid period (g) | End (g) |
1 | 197 | 199 | 210 |
2 | 202 | 203 | 212 |
3 | 200 | 203 | 210 |
4 | 195 | 198 | 211 |
5 | 192 | 195 | 208 |
X | 197.2 | 199.6 | 210.2 |
DS | 3.96 | 3.44 | 1.48 |
X= average
SD= standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation
- Conclusions:
- LD50 (rat female) > 2000 mg/kg bw
- Executive summary:
Method
Acute oral toxicity study of the test item in Sprague Dawley rats was performed according to the OECD Guidelines No. 420 - Acute Oral Toxicity – fixed dose. In the present study, conducted as a ‘limit test’, single oral administration of the test item was made to a single group of five female Sprague Dawley rats at the dose of 2000 mg/kg bw, to assess its acute toxicity, through oral gavage.
After 4 hours from the administration, the normal pellet diet was provided. Following their treatment, the rats were observed for incidence of mortality and signs of toxicity for 14 days and then sacrificed and subjected to a necropsy examination. The rats were observed for: mortality, main organic functions evaluation, skin evaluation, mucous evaluation, mobility and sensitivity evaluation. The body weight was weekly recorded.
Observations
When tested at the dose of 2000 mg/kg bw, the test item did not induce any mortality in any of the treated rats. The body weight gained by treated rats was lower than species and strain standard during the first week of the study, and not found to be adversely affected during the second week. At gross necropsy, 2 animals showed a moderate mucous enteritis and 1 animal showed a slight enteritis. During the study, all animals showed piloerection 4 hours after treatment and tucked up abdomen after 24 hours from the administration. These symptoms disappeared in 2 animals after 7 days from the test start, and after 8 days in the other 3 tested animals.
Results
Based on these results, and according to the criteria for classification of chemicals OECD 420 the test article, is not classified under CLP regulation.
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