Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
Awaiting ECHA authorization
Justification for type of information:
CONSIDERATIONS OF ALTERNATIVE METHODS ON TESTING PROPOSALS IN YOUR REGISTRATION

This document will be published on ECHA website along with the third party consultation on the testing proposal(s).

Public substance name: dodecane-12-lactam, manufacturing of, by-products from, distillation residues
EC Number (omit if confidential): 923-400-5

Date of considerations: 5 December 2016

Hazard endpoint for which vertebrate testing was proposed:

Reproductive toxicity (pre-natal developmental toxicity) with the registered substance in rats;

Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information (instruction: please address all points below):

• available GLP studies

None

• available non-GLP studies
None

• historical human data
None

• (Q)SAR
According to ECHA guidance, QSAR approaches are currently not well fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction. (Chapter R.7a, R 7.6.4.1.2 - Version 4.1, October 2015): Page 382



• in vitro methods
In vitro studies are not available on the test substance.
Some in vitro methods are reported, however, according to Chapter R 7a Version 4.1, the regulatory acceptance of these in vitro studies has not been achieved as they do not provide equivalent information (see ECHA guidance R7a,october 2015 p.381).







• weight of evidence
No data is available on the first and second species for the test substance on comparable substance..

• grouping and read-across
No information is available from comparable substance.


• substance-tailored exposure driven testing [if applicable]
Not applicable

• [approaches in addition to above [if applicable]
Not applicable

• other reasons [if applicable]
None



Considerations that the specific adaptation possibilities of Annexes VI to X (and column 2 thereof) were not applicable (instruction: free text):

The specific adaptation possibilities for waiving the developmental test mentioned in colomn 2 in Annex X section 7.82 are not applicable for the test susbstance.

- Results from existing studies (prenatal developmental toxicity test or repeated-dose studies) are sufficient to support classification to category 1 B for effects on developmental toxicity and/or sexual function and fertility: not applicable
- Substance is a genotoxic carcinogen and appropriate risk management measure are implemented: not applicable
- Substance is known to be a germ cell mutagene and appropriate risk management are implemented: not applicable
- Substance is of low toxicological activity, no systemic absorption occurs via relevant route of exposure: not applicable

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
dodecane-12-lactam, manufacturing of, by-products from, distillation residues
EC Number:
923-400-5
IUPAC Name:
dodecane-12-lactam, manufacturing of, by-products from, distillation residues

Test animals

Species:
rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion