Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.7 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):
100
Dose descriptor starting point:
NOAEL
Value:
247 mg/kg bw/day
Value:
247 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling factor for rats
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
5
Justification:
default (worker)
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

No systemic hazard was identified based on a sub-acute inhalation toxicity study (OECD 412) conducted with the target substance butyl-S-lactate. The oral NOAEL of 125 mg/kg bw n-butanol (corresponding to 247 mg/kg bw/day butyl-S-lactate based on molecular weight extrapolation) derived from a sub-chronic repeated dose toxicity study was used in a route-to-route extrapolation for the dermal route. No systemic hazard was identified for the inhalation route which can be assumed to lead to higher absorption. Therefore, the chosen approach is conservative for assessing the hazard of the target substance via the dermal route.

The target substance is considered to induce local skin irritation (H315), but not dermal sensitisation. Butyl-S-lactate causes serious eye damage (H318) and is considered a respiratory irritant (H335).

According to the ECHA guidance on information requirements and chemical safety assessment (Part E: Risk Characterisation), substances classified as H318 are allocated to the moderate hazard band.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (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:
1.235 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
Dose descriptor starting point:
NOAEL
Value:
247 mg/kg bw/day
Value:
247 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling for rats
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default (general population)
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
1.235 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
Dose descriptor starting point:
NOAEL
Value:
247 mg/kg bw/day
Value:
247 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
sub-chroic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric factor for rats
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default (general population)
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

No systemic hazard was identified based on a sub-acute inhalation toxicity study (OECD 412) conducted with the target substance butyl-S-lactate. The oral NOAEL of 125 mg/kg bw n-butanol (corresponding to 247 mg/kg bw/day butyl-S-lactate based on molecular weight extrapolation) derived from a sub-chronic repeated dose toxicity study was used in a route-to-route extrapolation for the dermal route. No systemic hazard was identified for the inhalation route which can be assumed to lead to higher absorption. Therefore, the chosen approach is conservative for assessing the hazard of the target substance via the dermal route.

The target substance is considered to induce local skin irritation (H315), but not dermal sensitisation. Butyl-S-lactate causes serious eye damage (H318) and is considered a respiratory irritant (H335).

According to the ECHA guidance on information requirements and chemical safety assessment (Part E: Risk Characterisation), substances classified as H318 are allocated to the moderate hazard band.