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EC number: 202-228-8 | CAS number: 93-20-9
- 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
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- as outlined in ECHA guidance document R8
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation of exposure duration: sub-chronic to chronic (as outlined in ECHA guidance document R8).
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbit to human (as outlined in ECHA guidance document R8).
- AF for other interspecies differences:
- 2.5
- Justification:
- Rabbit to Human (as outlined in ECHA guidance document R8).
- AF for intraspecies differences:
- 5
- Justification:
- Workers (as outlined in ECHA guidance document R8).
- AF for the quality of the whole database:
- 1
- Justification:
- as outlined in ECHA guidance document R8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
The physico-chemical properties of the substance and its use demonstrate that there is negligible potential for inhalation exposure to the substance; consequently, no inhalation DNELs have been derived.
ECHA Guidance Document Chapter R.8, Appendix R.8-8 on Acute Toxicity states that a DNEL for acute toxicity is only necessary if "an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures". No acute toxicity hazard has been identified for the substance and, thus, no acute classification is proposed. Consequently, in accordance with the ECHA guidance, acute DN(M)ELs for systemic effects are not required.
The long term DNEL for systemic effects via the dermal route has been derived through read-across to a 90 day repeat dose dermal study on 2-phenoxyethanol. The data presented for material 2-phenoxyethanol (EC 204-589-7) is considered appropriate for read-across to EC 202-228-8 and to aid in the generation of DNELs and concluding on classification. The justification for the use of this read across is located within IUCLID section 13.
A NOAEL of 500 mg/kg/day (top dose tested) was observed based on lack of significant toxicological effects observed in the study. The DNEL was determined to be 8.33 mg/kg bw/day, conservatively assuming 100% absorption in both species using an assessment factor of 60.
The 90 day repeat dose dermal study is selected as the key effect level, this is the study more closely reflects the potential intermittent exposure during manufacture and use by restricting treatment to 6 hr/day, 5 days/week and changing occlusive wraps daily.
This study is chosen in preference to the dermal developmental toxicity/teratogenicity study (IUCLID section 7.8.2) in which significant maternal toxicity was observed at 600 mg/kg bw/day and the NOAEL was 300 mg/kg bw/day. The teratogenicity study involved 24 hour occlusive dermal exposure, the continuous exposure site occlusion method used may have contributed to alterations in the integrity of the epidermis as indicated by skin lesions in affected animals, resulting in enhanced absorption of the test material and subsequent development of hemolytic anemia.
Therefore the 90 day repeat dose study is considered more representative of potential exposure and is the more appropriate NOAEL to select as the key effect level.
The data available indicate the substance is not a dermal irritant or dermal sensitiser. Consequently, neither a short term or long-term DN(M)EL for local dermal effects is unnecessary.
EC-202-228-8 is classified as a Category 2 eye irritant based on the experimental data available. The in vitro eyeirritation study found EC 202-228-8 to be an eye irritant, it was therefore concluded in the interest of animal welfare it would be unethical to proceed to an in vivo eye irritation study. Therefore the eye irritation classification was determined using a weight of evidence approach. It is considered that the Testing And Evaluation Strategy in OECD TG 405 supports the view that there is no evidence that would require EC 202-228-8 to be classified as CLP Cat 1 (irreversible effects on the eye). It is considered that EC 202-228-8 does not to have potential to cause corrosion or serious eye damage because the in vitro skin test showed it to be non-irritating and the in vivo acute dermal toxicity test revealed no toxicity and no dermal effects after a 24 h application of the limit dose (2,000 mg/kg). Although not yet validated, it is considered that the finding from the in vitro ocular test is good evidence that EC 202-228-8 is an eye irritant, and as such should be classified as a Cat 2 for eye irritant in accordance with CLP. As the registration substance is only classified as irritating to the eyes (H319), it was assigned as a 'Low Hazard', this complies with ECHA document "Guidance on information requirements and chemical safety assessment,Part E: Risk Characterisation, section E 3.4.2."
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 4.167 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- as outlined in ECHA guidance document R8
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation of exposure duration: sub chronic to chronic (as outlined in ECHA guidance document R8).
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbit to human (as outlined in ECHA guidance document R8).
- AF for other interspecies differences:
- 2.5
- Justification:
- Rabbit to Human (as outlined in ECHA guidance document R8).
- AF for intraspecies differences:
- 10
- Justification:
- General Population (as outlined in ECHA guidance document R8).
- AF for the quality of the whole database:
- 1
- Justification:
- as outlined in ECHA guidance document R8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.083 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- as outlined in ECHA guidance document R8
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation of exposure duration: sub acute to chronic (as outlined in ECHA guidance document R8).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human (as outlined in ECHA guidance document R8).
- AF for other interspecies differences:
- 2.5
- Justification:
- Rat to Human (as outlined in ECHA guidance document R8).
- AF for intraspecies differences:
- 10
- Justification:
- General Population (as outlined in ECHA guidance document R8).
- AF for the quality of the whole database:
- 1
- Justification:
- as outlined in ECHA guidance document R8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
The physico-chemical properties of the substance and its use demonstrate that there is negligible potential for inhalation exposure to the substance; consequently, no inhalation DNELs have been derived.
ECHA Guidance Document Chapter R.8, Appendix R.8-8 on Acute Toxicity states that a DNEL for acute toxicity is only necessary if "an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures". No acute toxicity hazard has been identified for the substance and, thus, no acute classification is proposed. Consequently, in accordance with the ECHA guidance, acute DN(M)ELs for systemic effects are not required.
The long term DNEL for systemic effects via the dermal route has been derived using a 90 day repeat dose dermal study on 2-phenoxyethanol. The data presented for material 2-phenoxyethanol (EC 204-589-7) is considered appropriate for read-across to EC 202-228-8 and to aid in the generation of DNELs and concluding on classification. The justification for the use of this read across is located within IUCLID section 13.
A NOAEL of 500 mg/kg/day (top dose tested) was observed based on lack of significant toxicological effects observed in the study. The DNEL was determined to be 4.167 mg/kg bw/day, conservatively assuming 100% absorption in both species using an assessment factor of 120.
The 90 day repeat dose dermal study is selected as the key effect level, this is based on the attempts to more closely reflect the potential intermittent exposure during manufacture and use by restricting treatment to 6 hr/day, 5 days/week and changing occlusive wraps daily. This study is chosen in preference to the dermal developmental toxicity/teratogenicity study (IUCLID section 7.8.2) in which significant maternal toxicity was observed at 600 mg/kg bw/day and the NOAEL was 300 mg/kg bw/day. The teratogenicity study involved 24 hour occlusive dermal exposure, the continuous exposure site occlusion method used may have contributed to alterations in the integrity of the epidermis as indicated by skin lesions in affected animals, resulting in enhanced absorption of the test material and subsequent development of hemolytic anemia. Therefore the 90 day repeat dose study is considered more representative of potential exposure and is the more appropriate NOAEL to select as the key effect level.
The long term DNELs for systemic exposure via the oral route have been derived using a 28 day repeat dose study which gave a NOAEL of 50 mg/kg/day based on changes in serum chemistry (details located in IUCLID section 7.5.1). The DNEL was determined to be 0.083 mg/kg bw/day, conservatively assuming 100% absorption in both species using an assessment factor of 600.
The data available indicate the substance is not a dermal irritant or dermal sensitiser. Consequently, neither a short term or long-term DN(M)EL for local dermal effects is unnecessary.
EC-202-228-8 is classified as a Category 2 eye irritant based on the experimental data available. The In Vitro eye irritation study found EC 202-228-8 to be an eye irritant, it was therefore concluded in the interest of animal welfare it would be unethical to proceed to an In Vivo eye irritation study. Therefore the eye irritation classification was determined using a weight of evidence approach. It is considered that the Testing And Evaluation Strategy in OECD TG 405 supports the view that there is no evidence that would require EC 202-228-8 to be classified as CLP Cat 1 (irreversible effects on the eye). It is considered that EC 202-228-8 does not to have potential to cause corrosion or serious eye damage because the in vitro skin test showed it to be non-irritating and the in vivo acute dermal toxicity test revealed no toxicity and no dermal effects after a 24 h application at the limit dose (2,000 mg/kg). Although not yet validated, it is considered that the finding from the in vitro ocular test is good evidence that EC 202-228-8 is an eye irritant, and as such should be classified as a Cat 2 for eye irritant in accordance with CLP. As the registration substance is only classified as irritating to the eyes (H319), it was assigned as a 'Low Hazard', this complies with ECHA document"Guidance on information requirements and chemical safety assessment,Part E: Risk Characterisation, section E 3.4.2."
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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