Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

A waiver for further reproductive/developmental toxicity testing is included, based on the information requirements outlined in the ECHA REACH fact sheet of 15/09/2009 (ref: ECHA-09-FS-05-EN) and based on the outcome of the Integrated Testing Strategy (ITS).

In addition to the toxicokinetics assessment, a toxicokinetics study in accordance with OECD417 was performed to determine the absorption, distribution and excretion of radiolabeled Activated Carbon - High Density Skeleton via the intratracheal route. The toxicokinetic testing in rats showed that only very minimal absorption and translocation of AC-HDS to other organs (mainly to tracheobronchal lymph nodes) occurs after intratracheal instillation. No translocation of AC-HDS to reproductive organs was observed as measured by a sensitive method using radiolabeled AC-HDS. The study concluded that no significant systemic absorption and no systemic exposure of reproductive organs occurs after intratracheal exposure to AC-HDS.

As the findings in a limited 1 -year repeated dose toxicity study (Gross and Nau, 1967), indicated that AC-HDS will primarily cause local effects by inhalation, a 90 -day repeated dose toxicity study by inhalation was performed in which special attention was paid to the investigation of the male and female reproductive organs. No effects were oberved on reproductive organs, sperm parameters or oestrus cycle. The results of the ITS indicate lack of systemic absorption via a relevant route of exposure and absence of effects on reproductive organs and function, justifying the waiving of further reproductive/ developmental toxicity testing. The results for AC-HDS are read across to AC-LDS. Therefore, developmental and two-generation reproduction toxicity studies with AC-LDS are waived.

Effect on fertility: via oral route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information
No key information
Additional information

A waiver for the screening test for reproductive/developmental toxicity is included, based on the information requirements outlined in the ECHA REACH fact sheet of 15/09/2009 (ref: ECHA-09-FS-05-EN). Based on the results of the toxicokinetics study and the 90 -day inhalation toxicity study as presented above, further reproductive/developmental toxicity studies are waived.

Justification for classification or non-classification

As no information is available for this endpoint, no conclusion on classification can be drawn.

Additional information