Registration Dossier

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Kinetics (absorption figures for oral, dermal and inhalation route of exposure)

No data on absorption are available. For dermal absorption, based on the physical-chemical properties of the substance (molecular weight < 500 g/mol [129.157 g/mol], log Kow -1.03 at 25°C, water solubility very soluble in water (miscible with water at 20°C at any ratio) low uptake is expected. Low dermal absorption is supported by the absence of adverse effects in the acute dermal toxicity study with N-(2-Hydroxyethyl)-2-pyrrolidon. Based on the above physical-chemical properties, oral absorption is also expected to be low. The absence of systemic effects at the high doses tested in the available oral toxicity studies with N-(2-Hydroxyethyl)-2-pyrrolidon supports low oral absorption.

Acute toxicity

N-(2-Hydroxyethyl)-2-pyrrolidon does not have to be classified for acute toxicity and therefore derivation of a DNELacute is not necessary.

 

Repeated dose toxicity

N-(2-Hydroxyethyl)-2-pyrrolidon was administered daily to rats by gavage at doses of 0, 100, 300 or 1000 mg/kg bw/day. Regarding clinical examinations, signs of general systemic toxicity were not observed in male or female parental animals up to the 1000 mg/kg bw/d dose of the compound. No treatment related adverse effects were observed on body weight, food consumption, heamatology, clinical chemistry or urinalysis.No treatment-related effects were seen in the Functional Observational Battery (FOB) parameters either. No treatment related effects were observed on organ weights of the parental animals nor when expressed as absolute - or relative weights. In the offspring, there were no treatment-related effects on body weight at any dose level. There were no external abnormalities noted at any dose group either. No treatment-related deaths or clinical signs of systemic toxicity in pups during lactation were noted at any treatment group. Therefore, derivation of a long-term DNEL is not neccessary.

 

Irritation / Sensitisation / Mutagenicity

N-(2-Hydroxyethyl)-2-pyrrolidon is considered to be not irritating to the skin and eye. Since the SIs were lower than 3 at all concentrations in the available LLNA, the results indicated that N-(2-hydroxyethyl)-2-pyrrolidon should not be considered a skin sensitiser.

Based on the available genetic toxicity data; non-mammalian and mammalian (mutagenicity and chromosome aberration) in vitro assays, the test substance is not classified for mutagenicity and thus not considered to be mutagenic. The results of the conducted Ames tests were mixed as dependent on the purity of the test-substance mutagenicity was observed. This however, is not supported by the mammalian tests as no mutagenicity was observed in the chromosome aberration and in the gene mutation assay which is the most significant assay.

 

Reproduction toxicity

No reproductive toxicity and no developmental toxicity was observed in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) in rats with N-(2 -Hydroxyethyl)-2 -pyrrolidon (tested at 0, 100, 300 or 1000 mg/kg bw/day). Thus, the NOAEL for reproductive and developmental toxicity was considered 1000 mg/kg bw/day. No DNEL has to be derived for developmental and reproductive toxicity.

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

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:
no hazard identified

Additional information - General Population

For a summary of the available toxicological data justifiying the non-derivation of all DNELs, please refer to "Additional information - Workers".