Registration Dossier
Registration Dossier
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EC number: 407-770-0 | CAS number: 61597-96-4 D(+)-LACTATE D'ISOBUTYLE
Toxicological Summary
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:
- no hazard identified
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
No systemic hazard was identified in a sub-acute inhalation study (OECD 412) with isobutyl lactate, or sub-chronic oral toxicity studies conducted with the primary metabolites isobutanol and lactic acid.
Isobutyl lactate is neither irritating to the skin nor a dermal sensitizer. No data on systemic toxicity is available for the dermal route. However, no systemic hazard was identified for the other routes (oral/inhalation) which can be assumed to lead to comparable or higher absorption. Therefore, it is concluded that no systemic hazard would occur from dermal exposure.
Isobutyl lactate causes serious eye irritation (H319) 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 in one or two of the categories for skin, eye or respiratory irritation (i.e. with H315, H319 or H335), are allocated to the low hazard band on the basis that effects due to such moderately irritant substances are anticipated at higher concentrations when compared to the high and moderate hazard band irritants.
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:
- no hazard identified
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
General Population - Hazard via oral 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
No systemic hazard was identified in a sub-acute inhalation study (OECD 412) with isobutyl lactate, or sub-chronic oral toxicity studies conducted with the primary metabolites isobutanol and lactic acid.
Isobutyl lactate is neither irritating to the skin nor a dermal sensitizer. No data on systemic toxicity is available for the dermal route. However, no systemic hazard was identified for the other routes (oral/inhalation) which can be assumed to lead to comparable or higher absorption. Therefore, it is concluded that no systemic hazard would occur from dermal exposure.
Isobutyl lactate causes serious eye irritation (H319) 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 in one or two of the categories for skin, eye or respiratory irritation (i.e. with H315, H319 or H335), are allocated to the low hazard band on the basis that effects due to such moderately irritant substances are anticipated at higher concentrations when compared to the high and moderate hazard band irritants.
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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