Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide, EC no.: 221-088-9 CAS no.: 3001-98-7

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]:
- No Developmental Toxicity GLP study with the substance is available to the applicant
- No such non-GLP studies are available to the applicant
- No historical human data regarding this endpoint is avalable to the applicant
- (Q)SAR does not provide relevant data to this endpoint
- In vitro methods are not available addressing repeated dose toxicity in vertebrates
- Weight of evidence: no data
- Grouping and read-across
: The applicant considers this developmental toxicity study (first species) is mandatory with the substance, because its molecule structure is free of functional groups causing adverse effects.
- Substance-tailored exposure driven testing: not applicable (0, 50, 300, 1000 mg/kg bw/day)
- Approaches in addition to above: not applicable
- Other reasons: In view of the exisiting OECD 422 test with the substance, the applicant expect not adverse effects for the developmental toxicity study. Such result cannot be proved in any other way than by testing.
The specific result of this study are mandatory for decisions on the necessarity for testing in vertebrates of further higher tier endpoints (devtox second species, reprotox, endokrine).

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
EC Number:
221-088-9
EC Name:
3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
Cas Number:
3001-98-7
Molecular formula:
C7H14O6P2
IUPAC Name:
3,9-dimethyl-2,4,8,10-tetraoxa-3lambda5,9lambda5-diphosphaspiro[5.5]undecane-3,9-dione
Test material form:
solid: particulate/powder
Details on test material:
AFLAMMIT® PCO 962

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion