Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The substance is classified as both a skin and respiratory sensitiser in accordance with the requirements of Directive 67/548/EEC (DSD) and Regulation 1272/2008 (CLP).

As such, sensitisation is to be regarded as the most sensitive end-point and no DNEL can be derived due to the lack of dose-response data. A qualitative risk characterisation is therefore necessary and this is detailed in the accompanying CSR.

 

Availability of a national Occupational Exposure Limit Value (OEL)

Exposure limits are currently in place for the registered substance, trimellitic anhydride (TMA).

Finland (Reference document: Sosiaali- ja terveysministeriön julkaisuja 2014:2. http: //urn. fi/URN: ISBN:978-952-00-3479-5) and (Valeurs limites d’exposition professionnelle aux agents chimiques en. ED 984. 2012) indicate an 8 hour limit of 0.04 mg/ m3.

The United Kingdom HSE (EH40/2005 Workplace exposure limits. Containing the list of workplace exposure limits for use with the Control of Substances Hazardous to Health Regulations (as amended)) and Spain (LÍMITES DE EXPOSICIÓN PROFESIONAL PARA AGENTES QUÍMICOS EN ESPAÑA 2014) have indicated an 8 hour TWA of 0.04 mg/ m3 and a 15 minute STEL of 0.12 mg/ m3.

Sweden has indicated a Level Limit Value of 0.04 mg/m3with a ceiling limit of 0.08 mg/m3 (Provisions of the Swedish Work Environment Authority on Occupational Exposure Limit Values and Measures against Air Contaminants, together with General Recommendations on the implementation of the Provisions. AFS 2005:17). More recently, in 2011, a guide value of 0.005 mg/ m3 has been stated by the Swedish Work Environment Authority for combined exposure to organic anhydrides during 15 minutes of inhalation. No further information on the scientific background and derivation method was made available. (Reference document: Chemical Hazards in the Working Environment Provisions and General Recommendations of the Swedish Work Environment Authority on Chemical Hazards in the Working Environment (2011) - AFS 2011:19).

The Netherlands indicates an 8 hour limit of 0.0018 mg/m3 (Ref: Subcommissie Grenswaarden Stoffen op de Werkplek (GSW) | SER. 21stApril 2010.

Belgium (Lijst van de grenswaarden voor blootstelling aan chemische agentia July 2014) and (Chemical Agent Regulations: Code of practice 2011) indicate a TWA of 0.0005 mg/ m3 with a 15 minute STEL of 0.002 mg/ m3.

For this substance, suitable personal protection equipment must be made available to workers and its use made mandatory to control potential exposure to within the concentration value of the applicable OEL.

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

Since no exposure of the general population is intended or anticipated, no DNELs have been derived.