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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
50 mg/m³
Study duration:
subchronic
Species:
rat
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Generally, no toxicologically relevant reproductive or developmental difference was observed between animals exposed to measured concentrations of 11.7, 48.4 and 156.8 mg/m³ and controls. These concentrations of pyrrolindine did not adversely impact the reproduction of these rats, nor did treatment impact delivery and pup viability. Furthermore, none of the F1 generation pups showed any evidence of developmental toxicity in response to pyrrolidine.

Conclusion:

Under the conditions of this OECD 422 combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in Wistar rats the following no observed adverse effect concentration (NOAEC) of pyrrolidine were determined:

The NOAEC for general, local toxicity at the respiratory tract was 50 mg/m³ for the F0 females and males based on histological findings in nasal cavity.

The NOAEC for general, systemic toxicity was 150 mg/m³ for the F0 females and males.

The NOAEC for reproductive performance and fertility was 150 mg/m³ for the F0 parental rats.

The NOAEC for developmental toxicity in the F1 offspring was 150 mg/m³.


Short description of key information:
Under the conditions of this OECD 422 combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in Wistar rats the following no observed adverse effect concentration (NOAEC) of pyrrolidine were determined:
The NOAEC for general, local toxicity at the respiratory tract was 50 mg/m³ for the F0 females and males based on histological findings in nasal cavity.

Justification for selection of Effect on fertility via inhalation route:
recent study

Effects on developmental toxicity

Description of key information
Based on the results of this study the NOAEC of piperidine for teratogenicity was 0.28 mg/L (80 ppm) since no adverse developmental effects were observed up to the highest concentration tested. These data can be read across to pyrrolidine, as further described in the rationale in chapter 13.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
280 mg/m³
Study duration:
subacute
Species:
rat
Quality of whole database:
The data are documented in an acceptable, well documented study report.
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

RA rationale to be added.


Justification for selection of Effect on developmental toxicity: via inhalation route:
One study available with the Read Across substance piperidine. The rationale for Read Across is included in chapter 13.

Justification for classification or non-classification

Based on the available data, pyrrolidine is not classified for reproductive or developmental toxicity.

Additional information