Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

According to „Guidance on information requirements and chemical safety assessment Part B: Hazard assessment” derivation of DNELs is not necessary if no adverse effects have been observed in studies at the highest recommended concentrations/doses tested. In all available acute toxicity tests Acetoguanamine is reported to cause no adverse effects at the highest recommended dose. Therefore no acute DNELs were derived.

No data from repeated dose toxicity studies, reproductive studies (including developmental toxicity) and carcinogenicity studies are available for Acetoguanamine. These studies are necessary to evaluate possible long term effects and derive long term DNELs on the basis of a reliable dose descriptor N(L)OAEL, benchmark dose etc. Because of this reason the registrant will derive long term DNELs for Acetoguanamine in case that adverse effects should appear in the proposed repeated dose studies.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
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

According to „Guidance on information requirements and chemical safety assessment Part B: Hazard assessment” derivation of DNELs is not necessary if no adverse effects have been observed in studies at the highest recommended concentrations/doses tested. In all available acute toxicity tests Acetoguanamine is reported to cause no adverse effects at the highest recommended dose. Therefore no acute DNELs could be derived.

No data from repeated dose toxicity studies, reproductive studies (including developmental toxicity) and carcinogenity studies are available for Acetoguanamine. These studies are necessary to evaluate possible long term effects and derive long term DNELs on the basis of a reliable dose descriptor N(L)OAEL, benchmark dose etc. Because of this reason the registrant will derive long term DNELs for Acetoguanamine in case that adverse effects should appear in the proposed repeated dose studies.