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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
52.08 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):
37.5
Modified dose descriptor starting point:
NOAEC
Value:
1 953 mg/m³
Explanation for the modification of the dose descriptor starting point:

Short branched chain carboxylic acids and their esters are rapidly absorbed from the gastrointestinal tract and have low systemic toxicity therefore, for systemic toxicity, route-to-route extrapolation is considered valid.

AF for dose response relationship:
1
Justification:
Default AF: Clear discriminating dose
AF for differences in duration of exposure:
3
Justification:
Default AF not considered necessary. Value appropriate for AF converting extended exposure to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
AF appropriate for inhalation-inhalation extrapolation (no allometric scaling)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Default AF: High quality studies, Klimisch score 1
AF for remaining uncertainties:
1
Justification:
Default AF; The assessment factors are already conservative. A further assessment factor is not necessary
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
Modified dose descriptor starting point:
other: LC50 >5.967 mg/L
Justification:
N/A
Justification:
N/A
Justification:
N/A
Justification:
N/A
Justification:
N/A
Justification:
N/A

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: A DNEL is not required according to ECHA guidance chapter R8 since no acute toxicity hazard leading to C&L has been identified.
Dose descriptor starting point:
other: LC50 >5967 mg/m3
Justification:
N/A
Justification:
N/A
Justification:
N/A
Justification:
N/A
Justification:
N/A
Justification:
N/A

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.67 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):
150
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Short branched chain carboxylic acids and their esters are rapidly absorbed from the gastrointestinal tract and have low systemic toxicity therefore, for systemic toxicity, route-to-route extrapolation is considered valid.

AF for dose response relationship:
1
Justification:
Default AF: Clear discriminating dose
AF for differences in duration of exposure:
3
Justification:
Default AF not considered necessary. Value appropriate for converting extended exposure to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF; Rat
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Default AF: High quality studies, Klimisch score 1
AF for remaining uncertainties:
1
Justification:
Default AF; The assessment factors are already conservative. A further assessment factor is not necessary
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Workers

Hazard via the inhalation route – systemic effects

Long term exposure

 

Hazard assessment conclusion

Most sensitive endpoint

Route of original study

DNEL 52.08 mg/m3

Repeated dose toxicity

oral

 

DN(M)EL related information A DNEL is required according to ECHA guidance chapter R.8. Exposure of the general population to EMB is considered highly likely according to the identified conditions of use. A long-term inhalation systemic DNEL can be derived from the repeated dose study conducted with EMB.   

Justification and comments In an OECD 422 study in which EMB was administered orally for 51 days at doses of up to 1000 mg/kg, no adverse effects were observed on either the dam or the foetuses and therefore the highest dose is effectively a limit dose. The NOAEL was therefore identified as 1000 mg/kg. Therefore the data are limited since they do not identify any adverse effect or target organ. The toxicity of EMB is considered to be very low based on information on structurally similar esters. WHO (1999)   

Dose descriptor NOAEL 1000 mg/kg bw/d in the rat and this value is used to derive the systemic long-term DNEL. This is considered to be a conservative estimate.

Modification of dose descriptor According to ECHA guidance, convert the rat oral NOAEL into a human inhalation NOAEC (mg/m3) after adjusting for differences in uptake between the two routes of exposure (TGD, Appendix R.8-2, example B3). 

NOAECinhalation = Oral NOAEL x [1/sRV] x[ABSoral-rat/ABSinhalation-human] x[sRVhuman/wRV]

NOAECinhalation =1000 x [1/0.343] x [100 / 100] x [6.7/10]

= 1953 mg/m3

 

Assessment factors

Uncertainty

ECHA AFs

Justification

Dose-response relationship

1

Default AF: Clear discriminating dose

Differences in duration of exposure

3

Default AF not considered necessary Value appropriate for extended exposure converting AF to chronic

Interspecies differences (allometric scaling)

1

Not appropriate for inhalation-inhalation extrapolation (no allometric scaling)

Other interspecies differences

2.5

 Default value

Intraspecies differences

5

Default value for workers 

Quality of database

1

High quality studies, Klimisch score 1

Remaining uncertainties

1

Default AF; The assessment factors are already conservative. A further assessment factor is not necessary.

Overall AF

37.5

 

 

Calculated DNEL for long-term inhalation systemic exposure for consumers is 52.08 mg/m3using an overall assessment factor of 37.5. This is considered to be a conservative DNEL based on the low toxicity of other short-chain alkyl esters.

 

Hazard via the dermal route - systemic effects

Long term exposure

 

Hazard assessment conclusion

Most sensitive endpoint

Route of original study

DNEL 6.67 mg/kg bw/day

Repeated dose toxicity

oral

 

DN(M)EL related information A DNEL is required according to ECHA guidance chapter R.8. Potential exposure of workers to EMB is considered highly likely. A long-term dermal systemic DNEL can be derived from the repeated dose study conducted with EMB.   

Justification and comments In an OECD 422 study in which EMB was administered orally for 51 days at doses of up to 1000 mg/kg, no adverse effects were observed on either the dam or the foetuses and therefore the highest dose is effectively a limit dose. The NOAEL was identified as 1000 mg/kg. Therefore the data are limited since they do not identify any adverse effect or target organ. The toxicity of EMB and EMV is considered to be very low based on information on structurally similar esters. WHO (1999).

Dose descriptor NOAEL 1000 mg/kg bw/day in the rat and this value is used to derive the systemic long-term DNEL. This is considered to be a conservative estimate.

Modification of dose descriptor According to ECHA guidance, convert the rat oral NOAEL into a human dermal NOAEL (mg/kg bw) after adjusting for differences in uptake between the two routes of exposure (TGD, Appendix R.8-2, example B3). 

NOAELdermal= Oral NOAEL x[ABSoral-rat/ABSdermal-human]

NOAELdermal=1000 x [100 / 100]

= 1000 mg/kg bw/day

 

Assessment factors

Uncertainty

ECHA AFs

Justification

Dose-response relationship

1

Default AF: Clear discriminating dose

Differences in duration of exposure

3

AF converting not considered necessary. Value appropriate for AF converting extended exposure to chronic

Interspecies differences (allometric scaling)

4

Default AF; Rat

Other interspecies differences

2.5

 Default AF

Intraspecies differences

5

Default value for workers 

Quality of database

1

Default AF: High quality studies, Klimisch score 1

Remaining uncertainties

1

Default AF; None necessary

Overall AF

150

 

 

Calculated DNEL for long-term dermal systemic exposure for consumers is 6.67 mg/kg bw/day using an overall assessment factor of 150. This is considered to be a conservative DNEL based on the low toxicity of other short-chain alkyl esters.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.95 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:
971 mg/m³
Explanation for the modification of the dose descriptor starting point:

Short branched chain carboxylic acids and their esters are rapidly absorbed from the gastrointestinal tract and have low systemic toxicity therefore, for systemic toxicity, route-to-route extrapolation is considered valid.

AF for dose response relationship:
1
Justification:
Default AF: Clear discriminating dose
AF for differences in duration of exposure:
3
Justification:
Default AF not considered necessary appropriate. Value appropriate for converting extended exposure to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not appropriate for inhalation-inhalation extrapolation (no allometric scaling)
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
High quality studies, Klimisch score 1
AF for remaining uncertainties:
1
Justification:
Default AF; None identified. The assessment factors are already conservative
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: A DNEL is not required according to ECHA guidance chapter R8 since no acute toxicity hazard leading to C&L has been identified.
Modified dose descriptor starting point:
other: LC50 >5967

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: A DNEL is not required according to ECHA guidance chapter R8 (Appendix 8-8) since no acute toxicity hazard leading to C&L has been identified.
Dose descriptor starting point:
other: LC50 >5967mg/m3

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
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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Short branched chain carboxylic acids and their esters are rapidly absorbed from the gastrointestinal tract and have low systemic toxicity therefore, for systemic toxicity, route-to-route extrapolation is considered valid.

AF for dose response relationship:
1
Justification:
Default AF: Clear discriminating dose
AF for differences in duration of exposure:
3
Justification:
Default AF not considered necessary. Value appropriate forconverting extended exposure to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF; Rat
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
High quality studies, Klimisch score 1
AF for remaining uncertainties:
1
Justification:
Default AF; None identified. The assessment factors are already conservative
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
3.33 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Short branched chain carboxylic acids and their esters are rapidly absorbed from the gastrointestinal tract and have low systemic toxicity therefore, for systemic toxicity, route-to-route extrapolation is considered valid.

AF for dose response relationship:
1
Justification:
Default AF: Clear discriminating dose
AF for differences in duration of exposure:
3
Justification:
Default AF not considered necessary Value appropriate for converting extended exposure to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF; Rat
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
High quality studies Klimisch 1
AF for remaining uncertainties:
1
Justification:
Default AF; None identified. The assessment factors are already conservative
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

General population

Hazard via the inhalation route – systemic effects

Long term exposure

 

Hazard assessment conclusion

Most sensitive endpoint

Route of original study

DNEL 12.95 mg/m3

Repeated dose toxicity

oral

 

DN(M)EL related information A DNEL is required according to ECHA guidance chapter R.8. Exposure of the general population to EMB is considered highly likely according to the identified conditions of use. A long-term inhalation systemic DNEL can be derived from the repeated dose study conducted with EMB.   

Justification and comments In an OECD 422 study in which EMB was administered orally for 51 days at doses of up to 1000 mg/kg, no adverse effects were observed on either the dam or the foetuses and therefore the highest dose is effectively a limit dose. The NOAEL was therefore identified as 1000 mg/kg. Therefore the data are limited since they do not identify any adverse effect or target organ. The toxicity of EMB is considered to be very low based on information on structurally similar esters. WHO (1999)   

Dose descriptor NOAEL 1000 mg/kg bw/d in the rat and this value is used to derive the systemic long-term DNEL. This is considered to be a conservative estimate.

Modification of dose descriptor According to ECHA guidance, convert the rat oral NOAEL into a human inhalation NOAEC (mg/m3) after adjusting for differences in uptake between the two routes of exposure (TGD, Appendix R.8-2, example B3). 

NOAECinhalation = Oral NOAEL x [1/sRV] x[ABSoral-rat/ABSinhalation-human]

NOAECinhalation =1000 x [1/1.030] x [100 / 100]

= 971 mg/m3

 

Assessment factors

Uncertainty

ECHA AFs

Justification

Dose-response relationship

1

Default AF: Clear discriminating dose

Differences in duration of exposure

3

Default AF not considered necessary Value appropriate for AF converting extended exposure to chronic

Interspecies differences (allometric scaling)

1

Not appropriate for inhalation-inhalation extrapolation

Other interspecies differences

2.5

 Default AF

Intraspecies differences

10

 Default value for general population

Quality of database

1

High quality studies, Klimisch score 1

Remaining uncertainties

1

Default AF; None identified. The assessment factors are already conservative.

Overall AF

75

 

 

Calculated DNEL for long-term inhalation systemic exposure for consumers is 12.95 mg/m3using an overall assessment factor of 75.

 

Hazard via the dermal route – systemic effects

Long term exposure

 

Hazard assessment conclusion

Most sensitive endpoint

Route of original study

DNEL3.33 mg/kg bw/day

Repeated dose toxicity

oral

 

DN(M)EL related informationA DNEL is required according to ECHA guidance chapter R.8. Exposure of the general population to EMB is considered highly likely according to the identified conditions of use. A long-term dermal systemic DNEL can be derived from the repeated dose study conducted with EMB.   

Justification and comments In an OECD 422 study in which EMB was administered orally for 51 days at doses of up to 1000 mg/kg, no adverse effects were observed on either the dam or the foetuses and therefore the highest dose is effectively a limit dose. The NOAEL was identified as 1000 mg/kg. Therefore the data are limited since they do not identify any adverse effect or target organ. The toxicity of EMB and EMV is considered to be very low based on information on structurally similar esters. WHO (1999)   

Dose descriptorNOAEL 1000 mg/kg bw/d in the rat and this value is used to derive the systemic long-term DNEL. This is considered to be a conservative estimate.

Modification of dose descriptor According to ECHA guidance, convert the rat oral NOAEL into a human dermal NOAEL (mg/kg bw) after adjusting for differences in uptake between the two routes of exposure (TGD, Appendix R.8-2, example B3). 

NOAELdermal= Oral NOAEL x[ABSoral-rat/ABSdermal-human]

NOAELdermal=1000 x [100 x 100]

= 1000 mg/kg bw/day

 

Assessment factors

Uncertainty

ECHA AFs

Justification

Dose-response relationship

1

Default AF: Clear discriminating dose

Differences in duration of exposure

3

Default AF not considered necessary. Value appropriate for converting extended exposure to chronic

Interspecies differences (allometric scaling)

4

Default AF; Rat

Other interspecies differences

2.5

 Default value

Intraspecies differences

10

 Default value for general population

Quality of database

1

High quality studies, Klimisch score 1

Remaining uncertainties

1

Default AF; None identified, assessment factors are already conservative

Overall AF

300

 

 

Calculated DNEL for long-term dermal systemic exposure for consumers is 3.33 mg/kg bw/day using an overall assessment factor of 300. This is considered to be a conservative DNEL based on the low toxicity of other short-chain alkyl esters.

 

Hazard via the oral route – systemic effects

Long term exposure

 

Hazard assessment conclusion

Most sensitive endpoint

Route of original study

DNEL3.33 mg/kg bw/day

Repeated dose toxicity

oral

 

DN(M)EL related information A DNEL is required according to ECHA guidance chapter R.8. Exposure of the general population to EMB is considered probable according to the identified conditions of use. A long-term oral systemic DNEL can be derived from the repeated dose study conducted with EMB.   

Justification and comments In an OECD 422 study in which EMB was administered orally for 51 days at doses of up to 1000 mg/kg, no adverse effects were observed on either the dam or the foetuses and therefore the highest dose is effectively a limit dose. The NOAEL was identified as 1000 mg/kg. Therefore the data are limited since they do not identify any adverse effect or target organ. The toxicity of EMB and EMV is considered to be very low based on information on structurally similar esters. WHO (1999)   

Dose descriptor NOAEL 1000 mg/kg bw/d in the rat and this value is used to derive the systemic long-term DNEL. This is considered to be a conservative estimate.

Modification of dose descriptor According to ECHA guidance, convert the rat oral NOAEL into a human oral NOAEL (mg/kg bw) after adjusting for differences in uptake between the two species (TGD, Appendix R.8-2, example B3). 

NOAELoral = Oral NOAEL x[ABSoral-rat/ABSoral-human]

NOAELoral =1000 x [100 / 100]

= 1000 mg/kg bw/day

 

Assessment factors

Uncertainty

ECHA AFs

Justification

Dose-response relationship

1

Default AF: Clear discriminating dose

Differences in duration of exposure

3

Default AF not considered necessary. Value appropriate for AF converting extended exposure to chronic

Interspecies differences (allometric scaling)

4

Default AF; Rat

Other interspecies differences

2.5

 Default value

Intraspecies differences

10

 Default value general population

Quality of database

1

High quality studies, Klimisch score 1

Remaining uncertainties

1

Default AF; None identified. The assessment factors are already conservative.

Overall AF

300

 

 

Calculated DNEL for long-term dermal systemic exposure for consumers is 3.33 mg/kg bw/day using an overall assessment factor of 300. This is considered to be a conservative DNEL based on the low toxicity of other short-chain alkyl esters.