Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The testing programme on CarboNeXT for human health considered that exposure to the material was for professional personnel and trough dermal route only, therefore short-term and repeated toxicity tests were performed only for dermal route. Indeed, CarboNeXT is a powdered solid, with only less than 4.16% of particles having a aerodynamic diameter below 40.3 µm, and with a maximum diameter of 2 mm, consequently the inhalable and the respirable fraction is negligible.

In the acute toxicity study, the dermal LD50resulted higher than 2,000 mg/kg bw, therefore the material is not considered of short-term toxicity concern.

No NOEL could be obtained from the 28-day repeated toxicity test, as no effects could be observed in laboratory animals. Moreover, CarboNeXT resulted not irritating to the skin and eyes in twoin vitrotests, and not sensitizing in a LLNA on mice.

In summary, the material seemed to be inert in all toxicity test performed.

No mutagenicity tests could be carried out, because the material resulted insoluble in all tested vehicles. For this reason it could be expected that the material will not reach target organs, and therefore no reproduction and carcinogenicity test were performed. Moreover, carcinogenicity testing was not required by the tonnage band of the material.

Considering the non-toxicity of the material, resulted from the toxicity studies performed, and since no NOELs are available, no DNELs have been derived.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

No DNELs have been derived and no assessment has been performed for general population, because CarboNeXT is for professional use only and consumer exposure is not foreseen. Indeed after manufacturing, CarboNeXT is pressed and packed into tightly closed boxes, and directly transported to the site of use, where it is completely burt to generate energy, without any dispersion into the environment.