Registration Dossier

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) sulphonyl]amino]propylammonium hydroxide

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
There are no GLP or non-GLP studies equivalent to the extended 1-generation reproduction study with this substance. There is no human data available. This substance does not easily lend itself to a grouping or read across based on structure. There are currently no approved in vitro or (Q)SAR methods substitutes for the extended 1-generation reproduction study.

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
There are no Column 2 adaptations applicable to waiving this study.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
To be in-line with the general goal of REACH to reduce animal testing, we are proposing to wait for the study outcome of the proposed 90-day oral repeat dose toxicity study to determine if the extended 1-generation study can be waived or if additional testing will be necessary.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
Justification for study design:
- Premating exposure duration for parental (P0) animals: The duration of the premating period will be approximately 75 days. This duration will cover the entire duration of the sperm cycle in male rats.
- Basis for dose level selection: Doses will be selected based on the results of the 90-day study (test plan submitted)
- Inclusion/exclusion of extension of Cohort 1B: This will be determined based in part on data gathered in the 90-day study (test plan submitted)
- Termination time for F2: This will be determined based in part on data gathered in the 90-day study (test plan submitted)
- Inclusion/exclusion of developmental neurotoxicity Cohorts 2A and 2B: This will be determined based in part on data gathered in the 90-day study (test plan submitted)
- Inclusion/exclusion of developmental immunotoxicity Cohort 3: This will be determined based in part on data gathered in the 90-day study (test plan submitted)
- Route of administration: Oral. This is the most relevant route of exposure for this test material

Test material

Constituent 1
Chemical structure
Reference substance name:
Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide
EC Number:
252-046-8
EC Name:
Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide
Cas Number:
34455-29-3
Molecular formula:
C15H19F13N2O4S
IUPAC Name:
carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide
Test material form:
solid

Results and discussion

Applicant's summary and conclusion