Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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