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Diss Factsheets
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EC number: 202-196-5 | CAS number: 92-84-2
- 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
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.53 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13.13 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- According to ECHA-guidance R.8.
- AF for dose response relationship:
- 2
- Justification:
- According to ECHA-guidance R.8.
- AF for differences in duration of exposure:
- 2
- Justification:
- According to ECHA-guidance R.8.
- AF for interspecies differences (allometric scaling):
- 1.6
- Justification:
- According to ECHA-guidance R.8.
- AF for other interspecies differences:
- 2.5
- Justification:
- According to ECHA-guidance R.8.
- AF for intraspecies differences:
- 5
- Justification:
- According to ECHA-guidance R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- According to ECHA-guidance R.8.
- AF for remaining uncertainties:
- 1
- Justification:
- According to ECHA-guidance R.8.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.59 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
- According to ECHA-guidance R.8.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3.75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- According to ECHA-guidance R.8.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 1.6
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Allometric scaling factor
Based on the body weight given in the study report of the oral sub-chronic repeated dose study and according ECHA Guidance R.8, p.24, the allometric scaling factor is calculated to be 1.6.
Long-term exposure: Systemic Effects
a) Inhalation DNEL
One oral sub-chronic repeated dose study was available. This study was used for calculation of a dermal DNEL for long-term systemic effects. Before applying appropriate assessment factors the NOAEL from the repeated dose study needs to be corrected according to ECHA Guidance R.8.
Data regarding absorption of phenothiazine from the gastrointestinal tract after oral application indicate that in best case 50% of orally administered phenothiazine are actually absorbed. Therefore it is prudent to apply an additional safety factor of 2 to correct for oral and dermal absorption (according to ECHA Guidance R.8, p.19). Respiratory volumes and exposure duration need to be taken into account according to ECHA Guidance R.8, p. 20 and 59).
The corrected NOAEC for workers is calculated to be: 13.13 mg/m3. All further assessment factors according to ECHA Guidance R.8 are applied to this corrected dose descriptor.
b) Dermal DNEL
The same oral sub-chronic repeated dose study as mentioned for "Inhalation DNEL" was used to derive a dermal DNEL.
No reliable data on dermal absorption was available. However, in the study for acute dermal toxicity no signs of systemic toxicity were found. Following ECHA Guidance R.8, p19 ("On the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.") no additional factor was introduced. No further correction of the NOAEL resulting from the oral sub-chronic repeated dose study was necessary, i.e. the same value as for oral application was taken for calculation of the dermal DNEL.
Qualitative approach for short-term exposure and long-term exposure: Local effects
Phenothiazine is not classified as either irritating to skin or to the eye. Following the results of a guinea pig maximisation test on skin sensitising properties, phenothiazine has a weak skin sensitising potential. However, there is no dose-response information available, hence making calculation of an appropriate DNEL not possible. Therefore, a qualitative approach (acc. ECHA Guidance) is followed.
Risk management measures (RMM) and operational conditions (OC) may be chosen in relation to the potency of the sensitizer (see ECHA Guidance R.8, p120). Based on the respective guidance and the present study result, a moderate incidence of sensitization can be assumed for phenothiazine. A qualitative approach for choosing appropriate RMMs and OCs is described in ECHA Guidance Part E - Risk Characterisation, p15ff. There it is proposed that moderate R43 skin sensitizers (such as phenothiazine) are allocated to the moderate hazard category on the basis that exposure to these moderate skin sensitizing substances should be well controlled. RMMs proposed for moderate hazards (according to ECHA Guidance - Part E, Table E.3 -1) inter alia comprise: good standard of general ventilation, minimizing number of staff exposed and containment as appropriate should be considered/applied. Before any risk measurement measures are selected, a risk characterisation should take place, to relate exposure and the hazard categories.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.13 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 6.56 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- According to ECHA-guidance R.8.
- AF for dose response relationship:
- 2
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 1.6
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.39 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
- According to ECHA-guidance R.8.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3.75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- According to ECHA-guidance R.8.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 1.6
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3.75 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 1.6
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.24 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Allometric scaling factor
See discussion above (worker section).
Long-term exposure: Systemic Effects
a) Inhalation DNEL
See discussion above (worker section).
b) Dermal DNEL
See discussion above (worker section).
Qualitative approach for short-term exposure and long-term exposure: Local effects
See discussion above (worker section).
It is acknowledged in ECHA Guidance - Part E that RMMs for consumer preparations are limited. Since the actual implementation of technical controls and personal protective equipment (PPE) is usually difficult to achieve in practice, product-integrated measures (such as the maximum volume of the bottle, diluted preparations, etc.) are often the only appropriate RMMs.
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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