Registration Dossier
Registration Dossier
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EC number: 210-817-6 | CAS number: 623-84-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Acute DNELs - Systemic and local effects:
The available data indicate that PGDA is not acutely toxic via the dermal, oral or inhalation routes. It is not irritating to the eyes, skin or respiratory tract in acute studies and repeated dose exposure studies. Therefore there is no dose response information from which to derive a DNEL for acute systemic and local effects.
Long-term exposure - Systemic and Local effects:
In all the available repeated dose toxicity data on PGDA and the surrogate propylene glycol the highest dose tested was the no effect level for toxicity. In oral studies the highest dose tested was far in excess of the limit dose, and the highest dose tested in inhalation studies was limited by the maximum attainable concentration. In the available reproductive and developmental studies available on PGDA and its surrogate propylene glycol there were no effects on any reproductive or developmental parameter in multiple species.
A TK/metabolism study comparing molar equivalent amounts of radiolabeled PGDA and propylene glycol showed similar absorption and elimination parameters and indicated rapid metabolism of PGDA to propylene glycol (PG) and presumable acetic acid (not the labeled portion of PGDA). The PGDA/PG TK study dosed animals with 500 mg/kg bw PGDA which is less than the limit dose of 1000 mg/kg. However, the acute toxicity data on PGDA shows that by all major dose routes there are no deaths at 2000 mg/kg bw or greater and up to the highest attainable vapor concentration. PGDA has also been dosed in a 28-day study and developmental toxicity study at the limit dose of 1000 mg/kg bw/day with no adverse findings which shows the same lack of adverse toxicity as propylene glycol and acetic acid. Therefore, this weight of evidence (very low acute toxicity, lack of systemic toxicity at 1000 mg/kg PGDA and rapid metabolism to propylene glycol and acetic acid) supports the use of the highest dose levels from the read across material propylene glycol.
Based on the lack of observed treatment related effects in any of the aavailable studies there is no basis on which to set DNELs.
In addition, this substance is not classified according to CLP and therefore no risk assessment is considered necessary.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Acute DNELs - Systemic and local effects:
The available data indicate that PGDA is not acutely toxic via the dermal, oral or inhalation routes. It is not irritating to the eyes, skin or respiratory tract in acute studies and repeated dose exposure studies. Therefore there is no dose response information from which to derive a DNEL for acute systemic and local effects.
Long-term exposure - Systemic and Local effects:
In all the available repeated dose toxicity data on PGDA and the surrogate propylene glycol the highest dose tested was the no effect level for toxicity. In oral studies the highest dose tested was far in excess of the limit dose, and the highest dose tested in inhalation studies was limited by the maximum attainable concentration. In the available reproductive and developmental studies available on PGDA and its surrogate propylene glycol there were no effects on any reproductive or developmental parameter in multiple species.
A TK/metabolism study comparing molar equivalent amounts of radiolabeled PGDA and propylene glycol showed similar absorption and elimination parameters and indicated rapid metabolism of PGDA to propylene glycol (PG) and presumable acetic acid (not the labeled portion of PGDA). The PGDA/PG TK study dosed animals with 500 mg/kg bw PGDA which is less than the limit dose of 1000 mg/kg. However, the acute toxicity data on PGDA shows that by all major dose routes there are no deaths at 2000 mg/kg bw or greater and up to the highest attainable vapor concentration. PGDA has also been dosed in a 28-day study and developmental toxicity study at the limit dose of 1000 mg/kg bw/day with no adverse findings which shows the same lack of adverse toxicity as propylene glycol and acetic acid. Therefore, this weight of evidence (very low acute toxicity, lack of systemic toxicity at 1000 mg/kg PGDA and rapid metabolism to propylene glycol and acetic acid) supports the use of the highest dose levels from the read across material propylene glycol.
Based on the lack of observed treatment related effects in any of the aavailable studies there is no basis on which to set DNELs.
In addition, this substance is not classified according to CLP and therefore no risk assessment is considered necessary.
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