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EC number: 248-096-5 | CAS number: 26896-48-0
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Acute / short-term exposure - systemic effects
In acute toxicity studies, octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) has been shown to be of low toxicity.
LD50 oral: 2250 mg/kg bw (Hollander/Hoechst AG, 1975)
LD50 dermal: > 10,000 mg/kg bw (Collier/Safepharm, 1981)
Data on toxic effects by inhalation exposure have not been identified. Based on the low vapour pressure of TCD-Alcohol DM it is estimated that the saturated vapour concentration will be too low to cause acute toxic effects (see Sect. 7.2.2).
From studies available, reliable short-term dose response relations cannot be deduced. Acute toxicity data do not provide sufficient information on sublethal toxic effects to gather NOAELs as starting points. DNELs cannot be derived.
In accordance with ECHA Guidance on information requirements and chemical safety assessment - Chapter R.8, DN(M)EL need not be derived in case of low acute toxicity. Long-term DNELs are derived (see below), and these would be protective against short-term exposures.
Acute / short-term exposure - local effects
TCD-Alcohol DM is not irritating to the skin. However, it is irritating to eyes (Category 2). Data on inhalation exposure could not be located. From the data available, reliable dose descriptors cannot be obtained. A DNEL cannot be derived as there are no suitable starting points. For eye irritaing effects a qualitative risk assessment will be performed.
Long-term exposure - systemic effects
For TCD-Alcohol DM, initially only a screening study was available (OCED TG 422 combined repeated dose toxicity / reproduction/developmental toxicity screening test; NOTOX, 2010). No adverse effects were observed up to the highest dose tested (NOAEL of 600 mg/kg bw/day). Former DNELs were derived on basis of this study.
To date, results of the proposed tests are available as follows:
Repeated dose toxicity: NOAEL 1000 mg/kg bw/day in a OECD TG 408 study using rats (90-day, oral gavage; Huntingdon, 2013)
Developmental toxicity: NOAEL 1000 mg/kg bw/day in an OECD TG 414 (rats, oral gavage; Huntingdon, 2013). The NOEL of 500 mg/kg bw and day for maternal toxicity was based on statistically significantly decreases of food intake and bodyweight. This high dose effect was small and attributable to bad taste rather than toxicity and, therefore, it was not considered to be an advere effect.
Due to the finding that no adverse effects were observed in all three tests up to the highest dose tested (i.e. up to the limit dose of the 90 -day toxicity and developmental toxicity study) no hazard after repeated exposure to the substance could be identified and therefore, no DNEL values were derived.
Long-term exposure - local effects
The skin irritating potential of TCD-Alcohol DM is low as demonstrated in an acute skin irritation test. Dose descriptors for long term exposure local effects are not available, hence no DNEL for long-term-exposure local effects is derived. No local effects were seen in the 28 -day screening study or in the 90 -day study. Local effects in the developmental study were attributed to reflux, but not to TCD alcohol DM itself.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Acute / short-term exposure - systemic effects
In acute toxicity studies, octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) has been shown to be of low toxicity.
LD50 oral: 2250 mg/kg bw (Hollander/Hoechst AG, 1975)
LD50 dermal: > 10,000 mg/kg bw (Collier/Safepharm, 1981)
Data on toxic effects by inhalation exposure have not been identified. Based on the low vapour pressure,it is estimated that the saturated vapour concentration will be too low to cause acute toxic effects (see Sect. 7.2.2).
From studies available, reliable short-term dose response relations cannot be deduced. Acute toxicity data do not provide sufficient information on sublethal toxic effects to gather NOAELs as starting points. DNELs cannot be derived.
In accordance with ECHA Guidance on information requirements and chemical safety assessment - Chapter R.8, DN(M)EL need not be derived in case of low acute toxicity. Long-term DNELs are derived (see below), and these would be protective against short-term exposures.
Acute / short-term exposure - local effects
TCD-Alcohol DM is not irritating to skin. However it is irritating to eyes (Category 2). Data on inhalation exposure could not be located.
From the data available, reliable dose descriptors cannot be obtained. A DNEL cannot be derived as there are no suitable starting points. For eye irritaing effects a qualitative risk assessment will be performed.
Long-term exposure - systemic effects
For TCD-Alcohol DM, one study regarding repeated doses toxicity was initially available (OCED TG 422 combined repeated dose toxicity / reproduction/developmental toxicity screening test; NOTOX, 2010). No adverse effects were observed up to the highest dose tested (NOAEL of 600 mg/kg bw/day). Former DNELs were derived on basis of this study.
To date, results of the proposed tests are available as follows:
Repeated dose toxicity: NOAEL 1000 mg/kg bw/day in a OECD TG 408 study using rats (90-day, oral gavage; Huntingdon, 2013)
Developmental toxicity: NOAEL 1000 mg/kg bw/day in an OECD TG 414 (rats, oral gavage; Huntingdon, 2013). The NOEL of 500 mg/kg bw and day for maternal toxicity was based on statistically significantly decreases of food intake and bodyweight. This high dose effect was small and attributable to bad taste rather than toxicity and, therefore, it was not considered to be an advere effect.
Due to the finding that no adverse effects were observed in all three tests up to the highest dose tested (i.e. up to the limit dose of the 90 -day toxicity and developmental toxicity study) no hazard after repeated exposure to the substance could be identified and therefore, no DNEL values were derived.
Long-term exposure - local effects
In the repeated dose studies including the 90-day repeated dose toxicity study, no local effects were observed that were clearly attributable to the test substance up to the highest dose tested (1000 mg/kg bw/day).The skin irritating potential of TCD-Alcohol DM is low as demonstrated in an acute skin irritation test. Dose descriptors for long term exposure local effects are not available, hence no DNEL for long-term-exposure local effects is derived.
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