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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
4.7 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
Modified dose descriptor starting point:
NOAEC
Value:
352.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
The oral NOAEL of 200 mg/kg bw/d, derived from the subacute OECD407-study, is converted to a NOAEC by dividing by 0.38 and multiplying by 0.67 according to ECHA Guidance taking into account differences in respiratory volume (rat/humans) and light-work activity by workers: NOAEC 200 * 0.67/ 0.38 = 352.6 mg/m3. As inhalatory and oral absorption are both considered 100%, no adjustment for absorption is applied.
AF for dose response relationship:
1
Justification:
NOAEC is used as a starting point
AF for differences in duration of exposure:
6
Justification:
AF based on a sub-acute study according to OECD407
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route according to ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default factor for other interspecies differences
AF for intraspecies differences:
5
Justification:
For workers the default factor of 5 is applied, according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
Underlying OECD407 study is rated Klimisch 1 performed under GLP without deviations
AF for remaining uncertainties:
1
Justification:
No further uncertainties have to be taken into account
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high 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:
6.66 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
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The oral NOAEL of 200 mg/kg bw/d, derived from the subacute OECD407-study, is converted to a dermal NOAL by applying a factor of 10 according to ECHA Guidance taking into account differences in absorption rate of the substance (10% dermal versus 100% oral): NOAEL(dermal) = 200 * 100/10 = 2000 mg/m3.
AF for dose response relationship:
1
Justification:
NOAEL is used as a starting point.
AF for differences in duration of exposure:
6
Justification:
AF based on a sub-acute study according to OECD407
AF for interspecies differences (allometric scaling):
4
Justification:
AF according to ECHA guidance as rats were used in the OECD407 study.
AF for other interspecies differences:
2.5
Justification:
Default factor for other interspecies differences
AF for intraspecies differences:
5
Justification:
For workers the default factor of 5 is applied, according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
Underlying OECD407 study is rated Klimisch 1 performed under GLP without deviations
AF for remaining uncertainties:
1
Justification:
No further uncertainties have to be taken into account
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

WORKER

Acute DNELs:

Production of epoxy resins is in excess of 10 t/y. According to the REACH "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, acute DNELs should default to the long term systemic DNELs.

 

For local effects, a DNEL was not quantifiable; however, as epoxy resins are classified as skin sensitizers, local effects must be assessed qualitatively and risk management measures applied as necessary. The potential for respiratory sensitization is unknown; however, given its skin sensitization potential, this endpoint also is assessed qualitatively.

Long-term DNELs:

DNELs are based on the oral 28-day study in rats (key study selected) entitled "A 28-Day Oral Gavage Toxicity Study of Butanediol Diglycidylether in Sprague Dawley Rats (WIL-749003)” with the most sensitive endpoint selected as repeated dose toxicity.

 

Starting Dose for DNEL calculation:

NOAEL: 200 mg/kg/day

 

Absorption Information:

Oral absorption was considered to be 100% based on experimental data.

Inhalation absorption was considered to be 100% based on consideration of the molecular weight and log Kow values.

Dermal absorption was considered to be 10% based on the physicochemical properties of epoxy resins and the lack of observed systemic effects following dermal exposure.

 

Modified dose for DNEL Calculation:

Worker – Inhalation = 200 mg/kg/day x 1/0.38 x 6.7/10 (no adjustment for absorption) = 352.6 mg/m3

Worker – Dermal = 200 mg/kg/day x 100%/10% (adjustment for absorption) = 2,000 mg/kg/day

 

Assessment Factors (AF) were selected as described in line with ECHA guidance documents.

 

Final DNELs:

Worker – Inhalation = 4.7 mg/m3

Worker – Dermal = 6.66 mg/kg/day

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.16 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
Modified dose descriptor starting point:
NOAEC
Value:
173.9 mg/m³
Explanation for the modification of the dose descriptor starting point:
The oral NOAEL of 200 mg/kg bw/d, derived from the subacute OECD407-study, is converted to a NOAEC by dividing by 1.15 according to ECHA Guidance taking into account differences in respiratory volume (rat/humans) by consumers: NOAEC 200 / 1.15 = 173.9 mg/m3. As inhalatory and oral absorption are both considered 100%, no adjustment for absorption is applied.
AF for dose response relationship:
1
Justification:
NOAEC is used as a starting point
AF for differences in duration of exposure:
6
Justification:
AF based on a sub-acute study according to OECD407
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route according to ECHA guidance
AF for other interspecies differences:
2.5
Justification:
Default factor for other interspecies differences
AF for intraspecies differences:
10
Justification:
For consumers the default factor of 10 is applied, according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
Underlying OECD407 study is rated Klimisch 1 performed under GLP without deviations
AF for remaining uncertainties:
1
Justification:
No further uncertainties have to be taken into account
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The oral NOAEL of 200 mg/kg bw/d, derived from the subacute OECD407-study, is converted to a dermal NOAL by applying a factor of 10 according to ECHA Guidance taking into account differences in absorption rate of the substance (10% dermal versus 100% oral): NOAEL(dermal) = 200 * 100/10 = 2000 mg/m3.
AF for dose response relationship:
1
Justification:
NOAEL is used as a starting point.
AF for differences in duration of exposure:
6
Justification:
AF based on a sub-acute study according to OECD407
AF for interspecies differences (allometric scaling):
4
Justification:
AF according to ECHA guidance as rats were used in the OECD407 study.
AF for other interspecies differences:
2.5
Justification:
Default factor for other interspecies differences
AF for intraspecies differences:
10
Justification:
For consumers the default factor of 10 is applied, according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
Underlying OECD407 study is rated Klimisch 1 performed under GLP without deviations
AF for remaining uncertainties:
1
Justification:
No further uncertainties have to be taken into account
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high 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:
0.33 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:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route to route extrapolation performed
AF for dose response relationship:
1
Justification:
NOAEL is used as a starting point.
AF for differences in duration of exposure:
6
Justification:
AF based on a sub-acute study according to OECD407
AF for interspecies differences (allometric scaling):
4
Justification:
AF according to ECHA guidance as rats were used in the OECD407 study.
AF for other interspecies differences:
2.5
Justification:
Default factor for other interspecies differences
AF for intraspecies differences:
10
Justification:
For consumers the default factor of 10 is applied, according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
Underlying OECD407 study is rated Klimisch 1 performed under GLP without deviations
AF for remaining uncertainties:
1
Justification:
No further uncertainties have to be taken into account
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

GENERAL POPULATION

Acute DNELs:

General population: Production of epoxy resins is in excess of 10 t/y. According to the REACH "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, acute DNELs should default to the long term systemic DNELs.

 

For local effects, a DNEL was not quantifiable; however, as epoxy resins are classified as skin sensitizers, local effects must be assessed qualitatively. The potential for respiratory sensitization is unknown; however, given its skin sensitization potential, this endpoint also is assessed qualitatively.

 

Long-term DNELs:

DNELs are based on the oral 28-day study in rats (key study selected) entitled "A 28-Day Oral Gavage Toxicity Study of Butanediol

Diglycidylether in Sprague Dawley Rats (WIL-749003)” with the most sensitive endpoint selected as repeated dose toxicity.

 

Starting Dose for DNEL calculation:

NOAEL: 200 mg/kg/day

 

Absorption Information:

Oral absorption was considered to be 100% based on experimental data.

Inhalation absorption was considered to be 100% based on consideration of the molecular weight and log Kow values.

Dermal absorption was considered to be 10% based on the physicochemical properties of epoxy resins and the lack of observed systemic effects following dermal exposure.

 

Modified dose for DNEL Calculation:

General Population – Oral =  200 mg/kg/day (no adjustment for absorption) = 200 mg/kg/day

General Population – Inhalation = 200 mg/kg/day x 1/1.15 (no adjustment for absorption) = 173.9 mg/m3

General Population– Dermal = 200 mg/kg/day x 100%/10% (adjustment for absorption) = 2,000 mg/kg/day

 

Assessment Factors (AF) were selected as described in line with ECHA guidance documents.

 

Final DNELs:

General Population – Oral =  0.33 mg/kg/day

General Population – Inhalation = 1.18 mg/m3

General Population– Dermal = 3.33 mg/kg/day