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Diss Factsheets
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EC number: 935-783-6 | 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
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:
- 3.32 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 82.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Route specific dose descriptor is not available.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was chosen
- AF for differences in duration of exposure:
- 2
- Justification:
- According to ECHA guidance document R8
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required according to ECHA guidance document R8
- AF for other interspecies differences:
- 2.5
- Justification:
- According to ECHA guidance document R8
- AF for intraspecies differences:
- 5
- Justification:
- According to ECHA guidance document R8
- AF for the quality of the whole database:
- 1
- Justification:
- database is reliable and of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- Not necessary
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
DNEL related information
- DNEL derivation method:
- other: VCI concept for corrosive substances
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.47 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 47 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of the 2 generation study resulted in the lowest DNEL
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was chosen
- AF for differences in duration of exposure:
- 2
- Justification:
- According to ECHA guidance document R8
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to ECHA guidance document R8
- AF for other interspecies differences:
- 2.5
- Justification:
- According to ECHA guidance document R8
- AF for intraspecies differences:
- 5
- Justification:
- According to ECHA guidance document R8
- AF for the quality of the whole database:
- 1
- Justification:
- database is reliable and of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- not necessary
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
No repeated dose toxicity study with Preventol KMX is available. However a read across to 4-chloro-3-methylphenol was shown to be scientifically reliable. A detailed justification for the read-across is provided in the technical dossier (see IUCLID Section 13) as well as in the Summary of Toxicokinetics, metabolism and distribution in IUCLID section 7.1).
Conversion of oral NOAEL to inhalatory NAEC
Since there is no dose descriptor for every exposure route, dose descriptors were converted into a correct starting point by route-to-route extrapolation based on the ECHA guidance document "Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health", November 2012.
The lowest NOAEL within a repeated dose study was achieved within a 2-generation oral feeding toxicity study performed on 4-chloro-3-methylphenol (Eiben, 2006). Systemic toxicity was observed in parental animals of the F0 and the F1 generation at 12000 and 3000 ppm, respectively. No effects on pups at dose levels of no or moderate maternal toxicity were evident. Nevertheless, conversion of the lowest dose level at which no adverse effect was observed using the body weight and food intake values resulted in the lowest NOAEL within all available repeated dose studies.Therefore, this NOAEL of 47 mg/kg bw/d was used as starting point to derive worker DNELs.
The conversion of an oral NOAEL into an inhalatory NAEC is performed using the following equation:
Corrected inhalatory NAEC = oral NOAEL x 1/sRVrat x ABSoral-rat/ ABSinh-human x sRVhuman/wRV
= oral NOAEL 47 mg/kg bw/d x 1/0.38m³/kg bw x 1 x 6.7 m³/10 m³
sRV: standard respiratory volume, ABS: absorption, wRV: worker respiratory volume
Thus, the corrected starting point for inhalation route was 47 x 6.7 / (10 x 0.38) = 82.9 mg/m3
Systemic DNEL derivation using the inhalatory NAEC
In the ECHA Guidance a factor of 2 is suggested for the extrapolation from oral to inhalation absorption. However, this factor is considered not relevant as toxicokinetic data on 4-chloro-3-methylphenol indicate an almost complete absorption of Preventol KMX after oral application. Factors for exposure duration (2), interspecies differences (2.5) and intraspecies differences (5) were applied according to ECHA Guidance document R8.
Thus, the long-term inhalation systemic DNEL is calculated to be 3.32 mg/m3.
Derivation of long-term inhalation local DNEL
Another approach to derive DNELs for substances whose primary effect on human health is irritation/corrosion was suggested by VCI (Verband der Chemischen Industrie e.V., 2010). A toxicological Task Force within the German VCI discussed the derivation of DNEL for local irritating compounds with a limited database. The experts developed upper boundary values for irritating and/or corrosive compounds based on available data. In particular the expert Task Force evaluated the German MAK-values published in the TRGS900 in 2009. For irritating compounds labelled with R36 or R38 but without relevant inhalation toxicity data available, the TF developed a generic upper boundary value of 10 mg/m3; for compounds with corrosive properties (R34 or R35) a respective value of 1 mg/m3 is developed.
Based on this approach the inhalation DNEL for long-term local effects is set to 1 mg/m3.
Conversion of oral NOAEL to dermal NAEL
The lowest NOAEL within a repeated dose study was achieved within a 2-generation oral feeding toxicity study performed on 4-chloro-3-methylphenol (Eiben, 2006). Systemic toxicity was observed in parental animals of the F0 and the F1 generation at 12000 and 3000 ppm, respectively. No effects on pups at dose levels of no or moderate maternal toxicity were evident. Nevertheless, conversion of the lowest dose level at which no adverse effect was observed using the body weight and food intake values, resulted in the lowest NOAEL within all available repeated dose studies.Therefore, this NOAEL of 47 mg/kg bw/d was used as starting point to derive worker DNELs.
For calculating the systemic dermal DNEL for workers no absorption difference between rat and human skin was assumed. No factor for time extrapolation was used as the substance was administered 5 days/week. For the dermal long-term systemic worker DNEL the following AFs were applied according to ECHA Guidance document R8: inter species factor 2.5, allometric scaling factor 4, intra species factor 5, exposure duration factor 2; => overall AF= 100
Thus, the long-term systemic dermal DNEL for workers is 0.47 mg/kg bw/d.
As no hazard could be evidenced in the acute toxicity studies in a worst-case assumption the systemic short-term exposure is covered by the long-term systemic DNEL. However, due to its corrosive and skin sensitizing properties the substance was allocated to the medium hazard band.
Short-term local DNELs
Preventol KMX showed corrosive properties in an in vitro skin corrosion assay. Further data on sensitization indicate a medium hazard of Preventol KMX. Local effects will therefore be addressed via qualitative risk assessment and no DNELs for local effects are derived. The oral route is not relevant for workers. In addition it is assumed that only workers will come in contact with the neat substances
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.82 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 40.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Route specific dose descriptor is not available.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was chosen
- AF for differences in duration of exposure:
- 2
- Justification:
- According to ECHA guidance document R8
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to ECHA guidance document R8
- AF for other interspecies differences:
- 2.5
- Justification:
- According to ECHA guidance document R8
- AF for intraspecies differences:
- 10
- Justification:
- According to ECHA guidance document R8
- AF for the quality of the whole database:
- 1
- Justification:
- database is reliable and of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- not necessary
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long 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
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 47 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of the 2 generation study resulted in the lowest DNEL
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was chosen
- AF for differences in duration of exposure:
- 2
- Justification:
- According to ECHA guidance document R8
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to ECHA guidance document R8
- AF for other interspecies differences:
- 2.5
- Justification:
- According to ECHA guidance document R8
- AF for intraspecies differences:
- 10
- Justification:
- According to ECHA guidance document R8
- AF for the quality of the whole database:
- 1
- Justification:
- database is reliable and of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- not necessary
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long 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
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 47 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was chosen
- AF for differences in duration of exposure:
- 2
- Justification:
- According to ECHA guidance document R8
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to ECHA guidance document R8
- AF for other interspecies differences:
- 2.5
- Justification:
- According to ECHA guidance document R8
- AF for intraspecies differences:
- 10
- Justification:
- According to ECHA guidance document R8
- AF for the quality of the whole database:
- 1
- Justification:
- database is reliable and of high quality
- AF for remaining uncertainties:
- 1
- Justification:
- not necessary
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Preventol KMX is used as an odour agent in cleaning products. After initial industrial manufacturing (i.e. mixing of the ingredients) the concentration of Preventol KMX in the disinfectant concentrate (sales product) is 0.3 to 0.5%. The general population may therefore come into contact with Preventol KMX at concentrations of 0.3 to 0.5% by the use of the disinfectant concentrate. The ready to use mixture of the disinfectant is obtained after 20 fold dilution of the disinfectant concentrate with water and contains thereafter 0.015 to 0.025% Preventol KMX. Taken into account the dilution of Preventol KMX corrosion and irritation after skin contact or upon inhalation is not expected. Therefore no DNELs for local effects are assessed.However, due to its corrosive and skin sensitizing properties the substance was allocated to the medium hazard band.
No repeated dose toxicity study with Preventol KMX is available. However a read across to 4-chloro-3-methylphenol was shown to be scientifically reliable. A detailed justification for the read-across is provided in the technical dossier (see IUCLID Section 13) as well as in the Summary of Toxicokinetics, metabolism and distribution in IUCLID section 7.1).
Conversion of oral NOAEL to inhalatory NAEC
Since there is no dose descriptor for every exposure route, dose descriptors were converted into a correct starting point by route-to-route extrapolation based on the ECHA guidance document "Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health", November 2012.
The lowest NOAEL within a repeated dose study was achieved within a 2-generation oral feeding toxicity study performed on 4-chloro-3-methylphenol (Eiben, 2006). Systemic toxicity was observed in parental animals of the F0 and the F1 generation at 12000 and 3000 ppm, respectively. No effects on pups at dose levels of no or moderate maternal toxicity were evident. Nevertheless, conversion of the lowest dose level at which no adverse effect was observed, using the body weight and food intake values, resulted in the lowest NOAEL within all available repeated dose studies.Therefore, this NOAEL of 47 mg/kg bw/d was used as starting point to derive worker DNELs.
The conversion of an oral NOAEL into an inhalatory NAEC is performed using the following equations:
Corrected inhalatory NAEC = oral NOAEL x 1/sRVrat x ABSoral-rat/ABSinh-human
= oral NOAELmg/kg bw/dx 1/1.15 m³/kg bw x 1
sRV: standard respiratory volume, ABS: absorption
Thus, the corrected starting point for inhalation route was 47 x 1 / 1.15 = 40.9 mg/m3
Systemic DNEL derivation using the inhalatory NAEC
In the ECHA Guidance a factor of 2 is suggested for the extrapolation from oral to inhalation absorption. However, this factor is considered not relevant as toxicokinetic data on 4-chloro-3-methylphenol indicate an almost complete absorption of Preventol KMX after oral application. Factors for exposure duration (2), interspecies differences (2.5) and intraspecies differences (10) were applied according to ECHA Guidance document R8.
Thus, the long-term inhalation systemic DNEL is calculated to be 0.82 mg/m3.
Conversion of oral NOAEL to dermal NAEL
The lowest NOAEL within a repeated dose study was achieved within a 2-generation oral feeding toxicity study performed on 4-chloro-3-methylphenol (Eiben, 2006). Systemic toxicity was observed in parental animals of the F0 and the F1 generation at 12000 and 3000 ppm, respectively. No effects on pups at dose levels of no or moderate maternal toxicity were evident. Nevertheless, conversion of the lowest dose level at which no adverse effect was observed, using the body weight and food intake values, resulted in the lowest NOAEL within all available repeated dose studies.Therefore, this NOAEL of 47 mg/kg bw/d was used as starting point to derive worker DNELs.
For calculating the systemic dermal DNEL for the general population no absorption difference was assumed. For the dermal long-term systemic DNEL the following AFs were applied according to ECHA Guidance document R8:
inter species factor 2.5, allometric scaling factor 4, intra species factor 10, exposure duration factor 2 => overall AF= 200
Thus, the long-term systemic dermal DNEL for the general population is 0.24 mg/kg bw/d.
For the oral long-term systemic DNEL the following AFs were applied:
inter species factor 2.5, allometric scaling factor 4, intra species factor 10, exposure duration factor 2; => overall AF = 200
Thus, the long-term systemic oral DNEL for general population is 0.24 mg/kg bw/d.
Short-term local DNELs
The consumer will not get into contact with undiluted Preventol KMX. Therefore no DNELs for local effects are assessed.
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.