Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.