Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

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

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

 

Tridecylamine isomers are widely used as intermediate for corrosion inhibitors, agricultural products (fungicides), dyestuffs for mineral oils, and as a co-catalyst in the production of vitamin E). Long-term oral, dermal and inhalative intakes are the possible exposure routes of tridecylamine isomers. 

 

inhalative DNEL

The DNELs for long-term exposure is derived from the no observed effect level obtained in an subchronic 90 day oral repeated dose study, where a NOAEL (systemic toxicity) of 5 mg/kg bw/day was estimated (BASF AG, 2003). In general, the calculation of DNEL is based on the observed effect level which has to be modified as described in R8 (ECHA, May 2008).  For derivation of the inhalative DNEL, the oral NOAEL had to be corrected for interspecies difference between rat and human by the risk assessors 0.38 mg/m3and 6.7 m3/10 m3regarding breathing volume and frequency. An inhalative NOAEC of 8.8 mg/m3/d according to the procedure, recommended in the current guidance document was obtained (R8, ECHA 2008).

 

Additionally an assessment factor (AF) of 25 (interspezies: allometric scaling = 1; remaining differences = 1; intraspezies = 5; exposure duration = 2 (subchronic to chronic); dose-response = 1; quality of whole database = 1:

 

AF = 1 x 1 x 5 x 2 x 1 x 1 = 10) was calculated. Consequently, the inhalative long-term systemic DNEL derived was 0.875 mg/m3/d for the worker.  

 

systemic dermal DNEL

Based on the available results on skin and eye irritation tridecylamine isomers have to be considered as corrosive (EU R34; GHS Cat.1B). As the corrosive properties are the main effect triggering the local effects and the substance is not labelled for acute dermal toxicity as there are no data available - no dermal DNEL is derived!

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Justification for not deriving consumer based DNELs:

Tridecylamine is not sold for direct consumer use, but is used to make products used by the public. The use of Tridecylamine is mainly as an Intermediate where no residual levels can be expected. Additionally, Tridecylamine is used in industrial and professional applications without reaching the consumer.