Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Screening study for reproductive/developmental toxicity :

According to column 2 of Annex VIII, section 8.7.1 of REACH regulation, testing on reproductive toxicity (screening for reproductive/developmental toxicity (OECD 421 or 422)), does not need to be conducted if a pre-natal development toxicity study is available. In compliance with Annex IX, section 8.7.2 a testing proposal for developmental toxicity is submitted within the dossier. Thus, conducting of a screening study for reproductive/developmental toxicity is not necessary.

Two generation study:

According to column 2 of Annex IX, section 8.7.3 of REACH regulation a decision on the need to perform a study at this tonnage level should be based on the outcome of all relevant available data. At present no relevant data are available and a study proposal is submitted within the dossier for a developmental toxicity study. If data from this study is available, the need to perform a two generation reproductive toxicity study at this tonnage level will be evaluated.


Short description of key information:
There is no data available on the reproductive toxicity of Acetoguanamine.

Effects on developmental toxicity

Description of key information
There is no data available for the developmental toxicity on Acetoguanamine.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Testing proposal prenatal developmental toxicity:

According to Annex IX, section 8.7.2 of REACH Regulation a prenatal developmental toxicity study is required. Therefore study according to OECD 414 ("Prenatal Developmental Toxicity Study") with Acetogunamine is proposed.

Justification for classification or non-classification

There is no data available on reproductive toxicity with Acetoguanamine. Nevertheless there are no indications for a classification for reproductive toxicity at this time. Evaluation will be considered based on the outcome of the proposed developmental toxicity study.