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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

developmental toxicity
Type of information:
experimental study planned
Study period:
Awaiting ECHA authorization
Justification for type of information:

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


• available non-GLP studies

• historical human data

• (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 - 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]

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
according to 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:
dodecane-12-lactam, manufacturing of, by-products from, distillation residues

Test animals


Results and discussion

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion