Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
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
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
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

Exposure to ethyl-S-lactate at levels up to 2500 mg/m³ resulted in concentration-related adverse effects in the nose of all test groups and in growth retardation and decreased food consumption in rats exposed to 2500 mg ethyl lactate/m³ air. Growth retardation was explained by the impaired ability to smell and taste as a result of severe damage to the olfactory epithelium. Thus, toxicity is restricted to local effects that are considered to be related to severe damage to the olfactory epithelium and hyperplasia/hypertrophy of the respiratory epithelium (pH-change due to lactic acid). No indication of clear systemic effects have been reported.

Ethyl-S-lactate is considered to be irritating to the respiratory tract based on a decreased breathing rate (RD50 = 750 mg/m³) after acute exposure and cytotoxic effects (caused by the low pH of rapidly formed lactic acid) seen in the olfactory and respiratory epithelium after sub-acute exposure.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
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
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
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:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Exposure to ethyl-S-lactate at levels up to 2500 mg/m³ resulted in concentration-related adverse effects in the nose of all test groups and in growth retardation and decreased food consumption in rats exposed to 2500 mg ethyl-S-lactate/m³ air. Growth retardation was explained by the impaired ability to smell and taste as a result of severe damage to the olfactory epithelium. Thus, toxicity is restricted to local effects that are considered to be related to severe damage to the olfactory epithelium and hyperplasia/hypertrophy of the respiratory epithelium (pH-change due to lactic acid). No indication of clear systemic effects have been reported.

Ethyl-S-lactate is considered to be irritating to the respiratory tract based on a decreased breathing rate (RD50 = 750 mg/m³) after acute exposure and cytotoxic effects (caused by the low pH of rapidly formed lactic acid) seen in the olfactory and respiratory epithelium after sub-acute exposure.