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EC number: 479-940-2 | CAS number: 613246-75-6
- 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:
- 16.5 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 234.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation. A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route). Please refer to "Additional information".
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 46.7 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 14 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. A conservative approach is used assuming identical dermal and oral absorption values even though a low dermal absorption value can be expected due to the physico- chemical properties of Sika Hardener LJ. Please refer to “Additional information”.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- The default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA (2010).
Acute/short-term, systemic effects
Short-term DNELs are not required as the acute toxicity of SIKA Hardner LJ is low. The substance is not classified and labelled for acute systemic toxicity, according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), based on the test data for acute oral and dermal toxicity.
Acute/longterm, local effects
Skin irritation: Based on the available study SIKA Hardener LJ is not classified for skin irritation.
Eye irritation: SIKA Hardener LJ is a reaction product of the two substances 2,2-Dimethyl-3-lauroyl-propanal and Polyetheramin D 230. Upon contact with water SIKA Hardener LJ rapidly hydrolyses, re-forming the original reactants as degradation products, i.e. the aldehyde and amine component. SIKA Hardener LJ is expected to be irritating/corrosive to the eyes due to its basic properties. As no dose-response relationship is available a qualitative risk assessment is conducted.
Skin sensitization: SIKA Hardener LJ did not induce a skin sensitising reaction in the available Guinea Pig Maximization Test and is therefore considered non-sensitising to the skin.
Long term, systemic effects
Occupational exposure to SIKA Hardener LJ occurs mainly by dermal route, and may also occur by inhalation route. Therefore two long-term DNELs are calculated for workers. In view of the data used for evaluation, the "quality of whole database factor" and "dose-response factor" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.
Exposure by inhalation
Step 1: Selection of the relevant dose descriptor (starting point):
The NOAEL of 1000 mg/kg bw/day, assessed in the 28-day repeated dose oral toxicity study (2005) is identified as the relevant dose descriptor and starting point.
Step 2: Modification into a correct starting point:
Using a conservative approach, a worker DNEL (long-term inhalation exposure) is derived. This worker DNEL is considered to ensure an appropriate level of protection with regard to acute inhalation exposure (no high peaks of exposure expected).
Relevant dose descriptor (NOAEL): 1000 mg/kg bw/day
Standard respiratory volume of the rat (sRVrat) for 8 hours: 0.38 m³/kg bw/day
Oral absorption of the rat / inhalation absorption of humans (ABSoral-rat / ABSinh-human): 0.5
Standard respiratory volume of humans (sRVhuman) for 8 hours: 6.7 m³
Worker respiratory volume (wRV) for 8 hours with light physical activity: 10 m³
Differences experimental/human exposure conditions: 1.4
Corrected inhalatory NOAEC for workers
= 1000 mg/kg bw/day × 0.5 × (1 / 0.38 m³/kg bw/d) × (6.7 m³/10 m³) × 1.4
= 1234.2 mg/m³
Step 3: Use of assessment factors: 75
Interspecies: no allometric scaling factor is applied because an oral-to-inhalation route extrapolation is performed.
Intraspecies AF (worker): 5
Exposure duration AF: 6
AF interspecies, remaining differences: 2.5
In conclusion, long term systemic inhalation DNEL, workers = 16.4 mg/m3
Dermal exposure
Step 1: Selection of the relevant dose descriptor (starting point):
The OECD TG 407 is selected for DNEL derivation as it is the relevant repeated dose study performed in accordance to OECD guideline and GLP. In this study, the oral NOAEL is 1000 mg/kg bw/day.
Step 2: Modification of the starting point:
Using a conservative approach, a worker DNEL (long-term dermal exposure) is derived. Based on the physico-chemical properties of SIKA Hardener LJ (calculated log Kow: > 12 and water solubility: < 1 mg/L) dermal absorption is assumed to be 10 % of oral absorption. Differences experimental/human exposure conditions have been considered ( x1.4)
The corrected NOAEL and starting point is therefore 14000 mg/kg bw/day.
Step 3: Use of assessment factors: 300
Interspecies AF, allometric scaling (rat to human): 4
Intraspecies AF (worker): 5
Exposure duration AF: 6
AF interspecies, remaining differences: 2.5
In conclusion, long term systemic dermal DNEL, workers = 46.7 mg/kg bw/day
References (not included as endpoint study record)
- ECHA (2010). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health.Version 2. ECHA-2010 -G-19 –EN.
- ECHA (2010). Guidance on information requirements and chemical safety assessment.Chapter R.7.12: Endpoint specific guidance: Guidance on Toxicokinetics. May 2008
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 375 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated exposure by inhalation. A conservative approach is used assuming a two times higher absorption via the inhalation route (end route) as compared to the oral route (starting route). Please refer to "Additional Information".
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the relatively homogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
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:
- 16.7 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no relevant experimental data on repeated dermal exposure. A conservative approach is used assuming identical dermal and oral absorption values even though a low dermal absorption value can be expected due to the physico- chemical properties.
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the relatively homogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default extrapolation factor for exposure duration is used: subacute (starting point) to chronic (end point).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for the differences between rats and humans is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for other interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- The default value for the relatively homogenous group "general population" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
General
DNEL derivation for the test item is performed under consideration of the recommendations of ECHA (2010).
Acute/short-term, systemic effects
Short-term DNELs are not required as the acute toxicity of SIKA Hardener LJ is low. The substance is not classified and labelled for acute systemic toxicity, according to Directive 67/548/EEC (DSD) and Regulation EC 1272/2008 (CLP), based on the test data for acute oral and dermal toxicity.
Acute/longterm, local effects
Skin irritation: Based on the available study SIKA Hardener LJ is not classified for skin irritation.
Eye irritation: SIKA Hardener LJ is a reaction product of the two substances 2,2-Dimethyl-3-lauroyl-propanal and Polyetheramin D 230. Upon contact with water SIKA Hardener LJ rapidly hydrolyses, re-forming the original reactants as degradation products, i.e. the aldehyde and amine component. SIKA Hardener LJ is expected to be irritating/corrosive to the eyes due to its basic properties. As no dose-response relationship is available a qualitative risk assessment is conducted.
Skin sensitization: SIKA Hardener LJ did not induce a skin sensitising reaction in the available Guinea Pig Maximization Test and is therefore considered non-sensitising to the skin.
Long term, systemic effects
Consumer exposure to SIKA Hardener LJ occurs mainly by dermal route, and may also occur by oral and inhalation route. Therefore long-term DNELs are calculated for the general population. In view of the data used for evaluation, the "quality of whole database factor" and "dose-response factor" are considered to amount each to a value of 1, and are thus not shown in the calculations presented below.
Exposure by inhalation
Step 1: Selection of the relevant dose descriptor (starting point):
The NOAEL of 1000 mg/kg bw/day, assessed in the 28-day repeated dose oral toxicity study (2005) is identified as the relevant dose descriptor and starting point.
Step 2: Modification into a correct starting point:
Using a conservative approach, a general population DNEL (long-term inhalation exposure) is derived.
Relevant dose descriptor (NOAEL): 1000 mg/kg bw/day
Oral absorption of the rat / inhalation absorption of humans (ABSoral-rat / ABSinh-human): 0.5
Allometric scaling: 4
Body weight: 60 kg
Default respiratory volume of general population (wRV) for 24 hours: 20 m³/person
Corrected inhalatory NOAEC for general population
= 1000 mg/kg bw/day × 0.5 / 4 × 60 / 20
= 375 mg/m³
Step 3: Use of assessment factors: 150
Interspecies: no allometric scaling factor is applied because an oral-to-inhalation route extrapolation is performed.
Intraspecies AF (general population): 10
Exposure duration AF: 6
AF for interspecies, remaining differences: 2.5
In conclusion, long term systemic inhalation DNEL, general population = 2.5 mg/m3
Dermal exposure
Step 1: Selection of the relevant dose descriptor (starting point):
The NOAEL of 1000 mg/kg bw/day, assessed in the 28-day repeated dose oral toxicity study (2005) is identified as the relevant dose descriptor and starting point.
Step 2: Modification of the starting point:
Using a conservative approach, a general population DNEL (long-term dermal exposure) is derived. Based on the physico-chemical properties of SIKA Hardener LJ (calculated log Kow: > 12 and water solubility: < 1 mg/L) dermal absorption is assumed to be 10 % of oral absorption. The corrected NOAEL and starting point is therefore 10000 mg/kg bw/day.
Step 3: Use of assessment factors: 600
Interspecies AF, allometric scaling (rat to human): 4
Intraspecies AF (general population): 10
Exposure duration AF: 6
AF for remaining differences: 2.5
In conclusion, long term systemic dermal DNEL, general population = 16.7 mg/kg bw/day
Oral exposure
Step 1: Selection of the relevant dose descriptor (starting point):
The NOAEL of 1000 mg/kg bw/d, assessed in the 28-day repeated dose oral toxicity study (2005) is identified as the relevant dose descriptor and starting point.
Step 2: Use of assessment factors: 600
Interspecies AF, allometric scaling (rat to human): 4
Intraspecies AF (general population): 10
Exposure duration AF: 6
AF for remaining differences: 2.5
In conclusion, long term systemic oral DNEL, general population = 1.7 mg/kg bw/day
References (not included as endpoint study record)
- ECHA (2010) Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health. Version 2. ECHA-2010 -G-19 –EN.
- ECHA (2011) Guidance on information requirements and chemical safety assessment. Part B: Hazard assessment. Version 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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