Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
Start within 12 months after obtaining the results of the proposed 90-day study and the agreement of ECHA.
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: 7-ACT.

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No GLP-study is available.
- Available non-GLP studies No non-GLP-study is available.
- Historical human data: No historical human data are available.
- (Q)SAR: No reliable and recognized QSAR-tools are available for this toxicity endpoint.
- In vitro methods: No reliable and recognized in vitro methods are available for this toxicity endpoint.
- Weight of evidence: No WoE-approach is available for this toxicity endpoint.
- Grouping and read-across: No grouping and read-across approach is available for this toxicity endpoint.
- Substance-tailored exposure driven testing: The adaption rules are not applicable for this substance.
- Approaches in addition to above: No adequate approach is known.
- Other reasons: No other reason is known.

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:
- The adaptation possibilities are not relevant for this case..

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Not applicable.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Version / remarks:
newest
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(6R-trans)-7-amino-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
EC Number:
261-491-7
EC Name:
(6R-trans)-7-amino-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
Cas Number:
58909-56-1
Molecular formula:
C12H13N5O5S2
IUPAC Name:
7-amino-3-{[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage
Details on mating procedure:
As in OECD 414.
Duration of treatment / exposure:
As in OECD 414.
Frequency of treatment:
As in OECD 414.
Duration of test:
As in OECD 414.
No. of animals per sex per dose:
in OECD 414.
Control animals:
yes, concurrent vehicle
Details on study design:
in OECD 414.

Examinations

Maternal examinations:
As in OECD 414.
Ovaries and uterine content:
As in OECD 414.
Fetal examinations:
As in OECD 414.
Statistics:
As in OECD 414.

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

A developmental toxicity study in rats according to the method OECD 414 is proposed.

Categories Display