Registration Dossier

Administrative data

Description of key information

Acute Toxicity:
- oral: LD50: 820 mg/kg bw (rat);

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
820 mg/kg bw

Additional information

Oral:

The oral LD50 was 820 mg/kg bw in rats that received aqueous suspension of TDA at dose levels ranging from 0.2 to 1.6 ml/kg bw (BASF AG, 1970). Dyspnoea and restlessness, salivation piloerection, and hunched posture were reportedly noted at all dose levels within few minutes after dosing. Forced breathing and red encrusted eyes and noses were noted during the days after treatment. Signs subsided and were absent from postdose days 7 and 8 onwards. First deaths occurred within 24 hours postdose in the higher dose level groups. One animal of the lowest dose groups died between 7 and 10 days post treatment. Gross pathology revealed bloody smears of the snouts, diarrhoea, adhesions and atonic gastrointestinal tract in many animals. The steep mortality-dose curve and the signs of toxicity suggest that corrosivity of the test substance was the driving element for these effects.

 

Dermal:

There is no acute dermal study known to exist. In accordance with Column 2 of REACH Annex VIII, testing for acute dermal toxicity is not required as studies on skin irritation/corrosion indicate that Tridecylamine is corrosive to the skin.

 

Inhalation:

In a modern mouse bioassay (BASF AG, 1998) the sensory irritation potential of TDA was studied using the method of the American Society for Testing and Materials, Standard Test Method for Estimating Sensory Irritancy of Airborne Chemicals (ASTM E981). In this test, groups of 4 male Swiss mice were exposed head-only to TDA at 3.8, 7.7, 23 or 90 mg/m3 for 45 minutes. Whilst exposure to 3.8 and 7.7 mg/m3 did not result in any clinical signs, all mice exposed to 23 mg/m³ showed piloerection and one mouse in this group was also in a poor general condition. In the 90 mg/m3 group, all animals had labored breathing, piloerection, and all were in poor general state. Additional data were available from an inhalation risk test (IRT) which meets generally accepted scientific principles (BASF AG, 1970; Val. 3). The inhalation of a saturated vapor-air mixture for 8 hours caused no mortality. Irritation to the mucous membranes was noted on the day of exposure. The signs subsided and were absent on the following day.

Justification for classification or non-classification

TDA was of moderate acute oral toxicity in rats with an oral LD50 of 820 mg/kg bw. EU classification according to Annex VI of Directive 67/548/EEC: Xn, R22