Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 470-870-8 | CAS number: 690271-93-3
- 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
Acute oral toxicity test with female rats (OECD 425, OPPTS 870:1100): LD50 > 2000 mg/kg bw
Acute dermal toxicity test with male and female rats (EC B.3, OECD 402, OPPTS 870:1200): LD50> 5000 mg/kg bw
Acute inhalation test with male and female rats (EC B.2, OECD 403, OPPTS 870.1300): LC50 > 5.2 mg/L air
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:
- 13 July 2004 to 5 January 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP in accordance with an internationally recognised test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)IGS BR
- Sex:
- female
- Vehicle:
- other: Deionised water
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Female: 175 mg/kg bw; Number of animals: 1; Number of deaths: 0
Female: 550 mg/kg bw; Number of animals: 1; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0 - Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- No gross lesions were found in any animal during necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the oral LD50 was greater than 2000 mg/kg for female rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP in accordance with an internationally recognised test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: Ministry of Agriculture, Forestry, and Fisheries (MAFF) (1985). 59 NohSan Number 4200, Acute Inhalation Toxicity Study. Testing Guidelines for Toxicity Studies
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)IGS BR
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: Substance as such
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.2 mg/l
- 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 and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.2 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- Male: 5.2 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.2 mg/L; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Clinical signs of toxicity during exposure could not be visibly assessed due to the density of the test atmosphere and the fact that the rats were in nose-only restrainers. However, the normal response to an alerting response stimulus was determined duri
- Body weight:
- Female rats showed mainly slight (<9 g per day) to moderate (10 to 18 g per day) body weight losses over one to 3 days after exposure; male rats showed slight (<10 g per day) weight effects one day after exposure. These weight effects were followed by an essentially normal weight gain rate for the remainder of the recovery period in both sexes.
- Gross pathology:
- No gross lesions were present in the rats at necropsy.
- Other findings:
- One female rat had wet fur and a partially closed eye immediately after exposure; another female rat showed forelimb alopecia at the end of the recovery period.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for Terracess TF-S in male and female rats was greater than 5.2 mg/L.
Reference
The mean concentration of Terracess TF-S dust during the animal exposure was 5.2 ± 1.2 mg/L (mean ± S.D.). The mass median aerodynamic equivalent diameter, determined by cascade impactor measurement, was 3.0 μm with a geometric standard deviation of 1.6. The tested aerosol atmosphere was considered to be respirable in rats.
The chamber temperature during the animal exposure was 22 to 23°C, the relative humidity was 56 to 57%, the oxygen concentration was 20.9% and the airflow into the chamber was 24 L/min. These chamber environmental conditions were considered adequate for the conduct of the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5.3 mg/m³ air
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:
- 13 July 2004 to 5 January 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP in accordance with an internationally recognised test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: Ministry of Agriculture, Forestry, and Fisheries (MAFF) (1985). 59 NohSan Number 4200, Acute Dermal Toxicity. Testing Guidelines for Toxicity Studies
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)IGS BR
- Sex:
- male/female
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Substance as such
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 5 cm x 7.4 cm
- Type of wrap if used: 2-ply gauze patch. then stretch gauze bandage and self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): equivalent to 5000 mg/kg bw
- For solids, paste formed: yes (with 0.7 ml of deionised water - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg
- 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 and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, skin response - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: None
- Gross pathology:
- No gross lesions were present in the rats at necropsy
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the skin absorption LD50 for Terracess TF-L was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Acute oral toxicity
In a study conducted in accordance with OECD guidelines and under Good Laboratory Practice, a single dose of Terracess TF-L was administered by oral gavage to one fasted female rat each at a dose of 175 or 550 mg/kg and to three fasted female rats at a dose of 2000 mg/kg.
After 14 days of observations no deaths occurred, no clinical signs were observed, and no body weight loss occurred. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the oral LD50 for Terracess TF-L was greater than 2000 mg/kg for female rats.
Acute dermal toxicity
In a study conducted in accordance with OECD guidelines and under Good Laboratory Practice a single dose of Terracess TF-L was applied to the shaved, intact skin of 5 male and 5 female rats at a dose of 5000 mg/kg of body weight. The application site was covered with a semi- occlusive dressing for 24 hours, after which the test substance was removed. The rats were observed for 14 days following application.
No deaths occurred during the study. Four rats exhibited no clinical signs during the study. Ocular and nasal discharge, and body weight loss, observed in some rats was not related to the test substance. No dermal irritation was observed. No gross lesions were present in the rats at necropsy. Under the conditions of this study, the skin absorption LD50 for Terracess TF-L was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.
Acute inhalation toxicity
In a study conducted in accordance with OECD guidelines and under Good Laboratory Practice one group of 5 male and 5 female rats was exposed nose-only to Terracess TF-S dust for a single, 4-hour exposure period. Rats were then observed for a 14-day recovery period. Rats were exposed to a mean chamber concentration of 5.2 mg/L of Terracess TF-S dust. The mass median aerodynamic diameter (MMAD) of the generated aerosol was 3.0 μm.
All rats exposed to Terracess TF-S survived the exposure and subsequent recovery period. Female rats showed mainly slight to moderate body weight losses over one to 3 days after exposure; male rats showed slight weight effects one day after exposure. These weight effects were followed by an essentially normal weight gain rate for the remainder of the recovery period in both sexes. Clinical observations were minimal and occurred in 2 female rats. Gross pathology examination revealed no evidence of organ-specific toxicity in any rats sacrificed at the end of the recovery period. Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for Terracess TF-S in male and female rats was greater than 5.2 mg/L.
Justification for selection of acute toxicity – oral endpoint
One available and valid study.
Justification for selection of acute toxicity – inhalation endpoint
One available and valid study.
Justification for selection of acute toxicity – dermal endpoint
One available and valid study.
Justification for classification or non-classification
Based on the available studies, Terracess TF is not classified for acute toxicity according to Directive 67/548/EEC and CLP Regulation EC (No.) 1272/2008.
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.