Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

OECD 422 (combined repeated dose toxicity study with the reproductive/developmental toxicity screening test)

- Oral administration via food (incl. analytical verification)

- Graphite was tested up to the limit dose given in OECD 422 (nominal 1000mg/kg bw/day)

- Result: No signs of systemic toxicity were observed, no signs of any effects on development, reproduction, or fertility

- NOAEL based on nominal food intake = 1000mg/kg bw/day

Effect on fertility: via oral route
Dose descriptor:
NOAEL
813 mg/kg bw/day
Additional information

Two qualities of Graphite were considered for the present registration dossier: Synthetic Graphite (SG) and Expanded Graphite (EG). Both are high purity graphite qualities with SG having the higher purity (>99%) and no amounts of quartz or any other crystalline impurities. EG however may contain certain (but low) amounts of quartz (typical quantity: 0.9%) and muscovite (typical quantity: 1.2%), hence making EG a worst case scenario for some endpoints (e.g. inhalation and irritation). For this reason, EG was chosen as test item for this study as well. Since neither by inhalation nor oral administration any sign of systemic toxicity was found in all other studies and the fact that SG does not contain any impurities known to be problematic for developmental/reproductive toxicity, results obtained from testing EG in the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test are valid for SG, too.

Since the present study was conducted as a combined repeated dose toxicity study with the reproductive/developmental toxicity screening test, several NOAELs were obtained, all representing the nominal dose of 1000 mg/kg bw/day. However, the actual substance intake varied from about 813 mg/kg bw/day up to 1159 mg/kg bw/day. DNELs were calculated using the NOAEL of 813 mg/kg bw/day.

Short description of key information:

OECD 422 (combined repeated dose toxicity study with the reproductive/developmental toxicity screening test)

- Oral administration via food (incl. analytical verification)

- Graphite was tested up to the limit dose given in OECD 422 (nominal 1000mg/kg bw/day)

- Result: No signs of systemic toxicity were observed, no signs of any effects on development, reproduction, or fertility

- NOAEL based on nominal food intake = 1000mg/kg bw/day

Effects on developmental toxicity

Description of key information

OECD 422 (combined repeated dose toxicity study with the reproductive/developmental toxicity screening test)

- Oral administration via food (incl. analytical verification)

- Graphite was tested up to the limit dose given in OECD 422 (nominal 1000mg/kg bw/day)

Result: No signs of systemic toxicity were observed, no signs of any effects on development, reproduction, or fertility

- NOAEL based on nominal food intake = 1000mg/kg bw/day

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
813 mg/kg bw/day
Additional information

See discussion for effects on fertility.

Toxicity to reproduction: other studies

Additional information

See discussion for effects on fertility.

Justification for classification or non-classification

Based on the results of the present study and according to criteria laid down in Regulation (EC) No 1272/2008, Graphite is not regarded neither as being toxic to reproduction nor as being toxic to development or fertility.