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EC number: 951-766-6 | 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
Endpoint summary
Administrative data
Description of key information
- Oral LD50: 1380 mg/kg bw (K, Rel.2)
- Dermal LD50: 1260 mg/kg bw (WoE, Rel.2)
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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- - Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- (pre-GLP)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- No data
- Doses:
- 840, 1310, 2050, 3200 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations, observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data - Statistics:
- None
- Preliminary study:
- Not applicable
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 380 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 1 040 - < 1 720
- Mortality:
- - At 840 mg/kg bw: 1/10
- At 1310 mg/kg bw: 7/10
- At 2050 mg/kg bw: 9/10
- At 3200 mg/kg bw: 8/10
- At 5000 mg/kg bw: 10/10 - Clinical signs:
- other: - At 840 mg/kg bw: piloerection - At 1310 and 2050 mg/kg bw: lethargy and piloerection - At 3200 and 5000 mg/kg bw: lethargy, ataxia and loss of righting reflex.
- Gross pathology:
- No data
- Other findings:
- None
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the test conditions, the oral LD50 for test substance is 1380 mg/kg bw in rats. Therefore the test substance is classified as harmful if swallowed according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute oral toxicity study, Tonka Absolute was administered by oral route at a dose level of 840, 1310, 2050, 3200 and 5000 mg/kg bw in rats (ten/dose). Animals were observed for mortality and clinical signs for 14 days.
Mortality was observed at all tested doses. Piloerection, Lethargy, ataxia and loss of righting reflex were observed. In this study, the oral LD50 of Tabac absolute was 13800 mg/kg bw in rats.
Under the test conditions, the oral LD50 for test substance is 1380 mg/kg bw in rats. Therefore the test substance is classified as harmful if swallowed according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 380 mg/kg bw
- Quality of whole database:
- Only basic data given in the available studies. However, it was considered sufficiently robust to cover this endpoint.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
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:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Principles of method if other than guideline:
- - Standard acute method (limit test)
- GLP compliance:
- no
- Remarks:
- (pre GLP)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data.
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- No data.
- Duration of exposure:
- 24 h
- Doses:
- 320, 1250, 2500 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 2 animals at 320 mg/kg bw
4 animals at 1250 mg/kg bw
4 animals at 2500 mg/kg bw
2 animals at 5000 mg/kg bw - Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Clinical observations, observations for mortality and toxic effects were made daily for 14 days
- Necropsy of survivors performed: No data - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 260 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - At 320 mg/kg bw: 0/2
- At 1250 mg/kg bw: 3/4
- At 2500 mg/kg bw: 2/4
- At 5000 mg/kg bw: 2/2 - Clinical signs:
- other: - Clinical signs: none at 320 mg/kg bw. Anorexia and diarrhea observed at all higher doses. - Dermal reactions: moderate redness in 2, slight redness in 3.
- Gross pathology:
- No data available.
- Other findings:
- No data.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the test conditions, the dermal LD50 for test substance is 1260 mg/kg bw in rabbits. Therefore the test substance is classified as harmful in contact with skin according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute dermal toxicity study, Tonka Absolute was given by dermal application at a dose level of 320, 1250, 2500 and 5000 mg/kg bw in rabbits. Animals were observed for mortality and clinical signs for 14 days.
Mortality occurred during the study (3/4 at 1250 mg/kg bw, 2/4 at 2500 mg/kg bw and 2/4 at 5000 mg/kg bw). Anorexia and diarrhea were observed at all higher doses, slight redness in three rabbits and moderate in two others. In this study, the dermal LD50 of Tonka Absolute was 1260 mg/kg bw in rabbits.
Under the test conditions, the dermal LD50 for test substance is 1260 mg/kg bw in rabbits. Therefore the test substance is classified as harmful in contact with skin according to the criteria of the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 260 mg/kg bw
- Quality of whole database:
- Only basic data given in the available studies. However, it was considered sufficiently robust to cover this endpoint.
Additional information
Acute toxicity by orale route:
One study was available and considered as the key study (Moreno, 1973). In this study, Tonka Absolute was administered by oral route at 840, 1310, 2050, 3200 and 5000 mg/kg bw in rats (ten/dose). Animals were observed for mortality and clinical signs for 14 days.
Mortality was observed at all tested doses. Piloerection, Lethargy, ataxia and loss of righting reflexwere observed. In this study, the oral LD50 of Tabac absolute was 1380 mg/kg bw in rats.
The oral LD50 for test substance is 1380 mg/kg bw in rats.
Acute toxicity by dermal route:
One study was available and considered as the key study (Moreno, 1973). In this study, Tonka Absolute was given by dermal application at a dose level of 320, 1250, 2500 and 5000 mg/kg bw in rabbits.Animals were observed for mortality and clinical signs for 14 days.
Mortality occurred during the study (3/4 at 1250 mg/kg bw, 2/4 at 2500 mg/kg bw and 2/4 at 5000 mg/kg bw). Anorexia and diarrhea were observed at all higher doses, slight redness in three rabbits and moderate in two others.In this study, the dermal LD50 of Tonka Absolute was 1260 mg/kg bw in rabbits.
The dermal LD50 for test substance is 1260 mg/kg bw in rabbits.
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.
Self classification:
Acute toxicity (Oral):
Based on the available information, the substance is:
- classified into category 4 (H302), according to the CLP and to the GHS.
Acute toxicity (Dermal):
Based on the available information, the substance is:
- classified into category 4 (H312) according to the CLP and to the GHS.
Acute toxicity (Inhalation):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Specific target organ toxicity: single exposure (Oral):
The classification criteria according to the Annex I of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (oral) for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value (oral) for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3) according to the CLP and to the GHS are not metsince narcotic effects were not observed in the acute oral toxicity study.
Specific target organ toxicity: single exposure (Dermal):
The classification criteria according to the CLP and to the GHS as specific target organ toxicant (STOT)– single exposure, dermal are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value (dermal) for a Category 1 classification (C≤ 1000 mg/kg bw) and at the guidance value (dermal) for a Category 2 classification (2000 mg/kg bw ≥ C > 1000 mg/kg bw). No classification is required.
The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex I of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute dermal toxicity study.
Specific target organ toxicity: single exposure (Inhalation):
No information was available. Not required for substances at the REACH Annex VII tonnage level.
Aspiration hazard:
The substance is not a hydrocarbon and no effects were observed on lungs in oral studies, therefore the criteria for aspiration toxicity according to the CLP and to the GHS are not met.
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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