Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: oral
Type of information:
experimental study planned
Study period:
Sub-chronic oral toxicity with reproductive toxicty screen
Justification for type of information:
With reference to ECHA decision CCH-D-2114453719-37-01/F, data requests were made for Annex IX end points but in view of tonnage limit not being reached in this period, the testing is being down-graded to OECD 422 screening studies. There is no planned increase in tonnage to trigger future Annex IX requirements.
Attemnpts were previously made to adapt the endpoint to avoid animal testing based on corrosivity and citing animal welfare reasons, but this was rejected by ECHA
Data has not been found on similar substances and it is considered grouping or read-across is possible
Biological and abiotic degradation studies have been performed, but preliminarty results available at the time of this proposal suggest stability of th esubstance and no significant formation or transormation products or metabolites. The start of this work needs to be delayed until confirmation is received from the laboratory that evaluation of transformation products or metabolites will be possible to avoid animal testing. This confirmation is expected early 2021 (testing delayed in 2020 due to Covid restrictions).
• Available GLP studies - none
• Available non-GLP studies - none
• Grouping and read-across - previous request not accepted by ECHA
• Historical human data - no indication of human health concerns
• (Q)SAR - not possible for the UVCB
• In vitro methods - no validated method available
• Weight of evidence - previous request not accepted by ECHA, based on type of substance
• Substance-tailored exposure driven testing - previous request not accepted by ECHA, based on corrosive properties and use only under controlled industrial conditions.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Pyridinium, 1-(phenylmethyl)-,ethyl methyl derivs., chlorides
IUPAC Name:
Pyridinium, 1-(phenylmethyl)-,ethyl methyl derivs., chlorides

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Details on route of administration:
Note for animal welfare purposes, the test material will be administered in a buffered test mediaum to mitigate effect of pH
Analytical verification of doses or concentrations:
yes

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion