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

Workers - 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:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General consideration:

The primary route of anticipated industrial and professional exposure to the registration substance is via skin contact. Given its very low vapour pressure at room temperature, inhalation of the registration substance is not likely to be high. However, exposition to aerosols or droplets of an inhalable size cannot be ruled out.

The registration substance is harmful after single ingestion, corrosive after single skin contact and causes serious eye damage after contact. All effects seen after acute and repeated oral exposure are the result from the corrosive property of the registration substance. It is not possible to derive a local DNEL based on the available data. Because of its corrosive potential however, the registration substance should be attributed to a moderate hazard class according to the ECHA Guidance on information requirement and chemical safety assessment, Part E: Risk Characterisation. Appropriate qualitative risk management measures and operational conditions should therefore be implemented when developing exposure scenarios.

Workers - Hazard via inhalation route

Inhalation is not an exposure pathway of concern due to the very low vapour pressure and because the test substance is not a solid which excludes exposure to inhalable/respirable particles. In the unlikely event that the substance becomes airborne as an inhlable aerosol, the strong irritative properties of the submission substance will exhibit self-warning effects in the respiratory tract. Furthermore, these unlikely exposure scenario will also be covered by the qualitative risk assessment.

Wokers - Hazard via dermal route

Since Reaction mass of 1-(3-((C12-18-(even numbered))-alkyl-amino)propyl)guanidine acetate salt and 1-(C12-18-(even numbered))-alkyl-1-(3-guanidinopropyl)guanidine acetate salt and 1-(C12-18-(even numbered))-alkyl-tetrahydropyrimidin-2(1H)-imine acetate salt is corrosive, the systemic DNEL is considered not appropriate for risk assessment; the local effects will cover the systemic effects. Thus, a qualitative assessment is recommended (REACH Guidance on Information Requirements and Chemical Safety Assessment, Part E (Risk Characterisation) and Chapter R.13 (Risk Management Measures and Operational Conditions)).

The point of departure for the derivation of the DNEL is the NOAEL of 30 mg/kg bw/day in the 28-day repeated dose toxicity study. The NOAEL for maternal effects in the prenatal developmental toxicity study was 15 mg/kg bw/day, with a LOAEL of 45 mg/kg bw/day based on corrosion effects in the stomach. Evidence of similar effects were reported at 125 mg/kg bw/day, but not at 31.25 mg/kg bw/day, in the 14-day dose range finding experiment. It is considered, therefore, that the dose-response for local effects in these studies represents a continuum with an overall NOAEL of 30 mg/kg bw/day.

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

The submitted substance is not used in the consumer sector and respective uses are not supported. DNEL derivations for the general population are therefore not necessary and not required.