Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.052 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.26 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.014 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Additional information - workers

Based on the results from available studies on Anthraquinone for worker population, the most sensitive endpoint was general toxicity, with the endpoint-specific worker-DNELlong-termequal to 0.0136 mg/kg bw/day for dermal route of exposure and 0.052 mg/m3 for inhalatory exposure.

Since the probability of the peak inhalatory exposures of workers was confirmed forAnthraquinone, acute DNEL for inhalatory exposure was obtained by multiplication of DNELlong-terminhalatory by factor of 5.

Within reproduction toxicity screening, mainly general toxicity was reported. Mutagenicity and carcinogenicity data for Anthraquinone were controversial, predominantly due to the fact that testing material was contaminated witha structurally related contaminant 9-nitroanthracene. The protocol used, dose selection and purity (a low level of 9-nitroanthracene as a contaminant in the sample) may have been critical for the mutagenicity test results. Highly purified Anthraquinone itself was not proved to be a mutagen. Anthraquinone considered for this registration is 99.21% pure and does not contain 9-nitroanthracene as the contaminant. The same reasoning is valid for carcinogenicity. Based on the ongoing discussions, recent knowledge, uncertainties involved in the interpretation of the test results, and considering controversial data available from in vitro and in vivo carcinogenicity and mutagenicity studies, Anthraquinone is considered as a non-genotoxic and non-carcinogenic substance.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

DNELs were derived for workers only.The exposure of consumers and men via the environment to Anthraquinone is expected to be negligible.