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EC number: 815-182-4 | CAS number: 12058-75-2
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 October 2011 - 22 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau, November 24, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Specific details on test material used for the study:
- - Analytical purity: 100%
- Purity test date: 11 August 2011
- Lot/batch No.: IC96
- Expiration date of the lot/batch: 24 March 2014
- Storage: room temperature - Species:
- rat
- Strain:
- other: Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 209-235 g
- Housing: housed in groups of 3 rats of the same sex, in solid bottomed polycarbonate cages with a stainless steel mesh lid
- Diet (e.g. ad libitum): free access to a standard rodent diet (Rat and Mouse No.1 Maintenance Diet), except the overnight prior to and approximately 4 hours after dosing. The diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
- Water (e.g. ad libitum): freely available via polycarbonate bottles fitted with sipper tubes
- Acclimation period: at least 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -23 °C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- DOSAGE PREPARATION: formulations were stirred before and after the dosing procedure.
- formulations were prepared on the day of dosing. - Doses:
- The test substance was formulated at a concentration of 200 mg/ml in the vehicle and administered at a volume of 10 mL/kg bodyweight
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed soon after dosing and at frequent intervals for the remainder of Day1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment throughout the study.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of test substance was demonstrated to be greater than 2000 mg/kg bodyweight.
Reference
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 August 2012 - 25 October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: IC96
- Expiration date of the lot/batch: 24 March 2014
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at ambient temperature
Description: White powder
Purity: 100% - Species:
- rat
- Strain:
- other: Crl:CD (SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
In the initial consignment of animals, 4 male and 4 female Crl:CD (SD) rats were received from Charles River (UK) Ltd. The rats were ordered at 56 to 84 days of age and within a weight range of ±20% of the mean bodyweight for each sex. The animals were allowed to acclimatise to the conditions described below for 6 days before treatment commenced. For those animals selected for this study, their age at the start of treatment was 62 to 90 days and their bodyweights were in the range of 330 to 351 g for males and 230 to 238 g for females.
Each animal room was supplied with filtered fresh air, which was passed to atmosphere and not re-circulated. The temperature and relative humidity controls were maintained within the range of 19 to 23°C and 40 to 70% respectively. Artificial lighting was controlled to give a cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours.
The animals were housed three of one sex per cage. The cages were made of a polycarbonate body with a stainless steel mesh lid. Wood shavings (Lignocel 3/4) were used as bedding and were sterilised by autoclaving and changed at appropriate intervals each week. Cages, food hoppers and water bottles were changed at appropriate intervals.
Whilst in the home cage, animals were allowed free access to a standard rodent diet (Rat and Mouse No. 1 Maintenance Diet). This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent. Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes. - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 3.7 µm
- Geometric standard deviation (GSD):
- 2.6
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- No. of animals per sex per dose:
- 1 test group, which consisted of 3 male and 3 female animals
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 5.2 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- There were no unscheduled deaths
- Clinical signs:
- other: The clinical sign of test substance staining to the snout and jaw was observed in 2/3 males and 2/3 females immediately after the exposure, this sign was no longer evident at 1 hour post dose. In addition wet fur was observed in all animals immediately af
- Body weight:
- There were slight bodyweight losses in the individual bodyweights of both sexes on the day following the exposure, recovery from any loss was observed at the next weighing occasion, Day 4, after which growth continued for the remainder of the study.
- Gross pathology:
- The macroscopic examination performed after a single administration followed by a 14-day observation period revealed enlargement and pallor to the tracheobronchial lymph node of a single female (Animal 6B). The nature and incidence of the other finding (pelvic dilatation of the right kidney of male 1B) were consistent with the commonly seen background of macroscopic changes.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions of this study the LC50 (4-hour) of Terracess DSR is in excess of 5.20 mg/L for male and female rats.
Terracess DSR is included in Category 5 or unclassified according to the Globally Harmonised System
Reference
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 November 2011 - 23 November 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- 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:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Otsuka Chemical Co Ltd, batch IC96
- Storage condition of test material: Room temperature
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 373 to 401 g for males, and 242 to 255 for females
- Fasting period before study:
- Housing: individually from Day -1
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23C
- Humidity (%): 40 to 70%
- Air changes (per hr): periodic checks
- Photoperiod (hrs dark / hrs light): 12 hours
- Type of coverage:
- semiocclusive
- Vehicle:
- methylcellulose
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10
- Type of wrap if used: The treatment area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non-irritating dressing, and further covered by a waterproof dressing encircled firmly around the trunk of the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water (30 - 40°C)
- Time after start of exposure: 24 hours
TEST MATERIAL
- Concentration (if solution): 2000 mg/kg bodyweight
VEHICLE
- Amount(s) applied (volume or weight with unit): 2.0 mL/kg bodyweight
- Concentration (if solution): 1% - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 morning only).
- Frequency of weighing: Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths and no clinical signs were observed for any animal.
- Clinical signs:
- other: Very slight erythema was seen in one female (Animal No. F7) from Day 4 resolving by Day 15. No dermal reactions were seen in the remaining animals throughout the study
- Gross pathology:
- Macroscopic examination at study termination on Day 15 revealed pallor of the kidneys in four males (Nos. F1 – F4) and three females (Nos. F6 – F8). No abnormalities were revealed in any other animal at the macroscopic examination at this time.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute median lethal dermal dose (LD50) to rats of Terracess DSR was demonstrated to be greater than 2000 mg/kg bodyweight.
Terracess DSR is included in Category 5 or unclassified according to the Globally Harmonised System
Reference
Additional information
Justification for classification or non-classification
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