Registration Dossier

Administrative data

Description of key information

Oral: - acute toxicity, oral, rat, Wistar, OECD 401 (limit test), LD50 >= (female/male) 2000 mg/kg bw, one death male and one death female for read across substance tri-n-octylamine

Dermal: - acute toxicity, dermal, rat, Wistar, OECD 402, LD50 > (female/male) 5000mg/kg bw for read across substance Amines, tri-C8-10-alkyl

Inhalation: - No information on acute inhalation available for trioctylamine

Key value for chemical safety assessment

Additional information

There is no data available for tridodecylamine. Suitable read across candidates for which data is available are Tri-N-Octylamine (CAS # 1116-76-3) and Amines, tri-C8 -10 -alkyl (CAS # 68814 -95 -9):

Oral:

OECD conform studies:

An acute oral toxicity study was conducted following a study protocol comparable to OECD guideline No. 401 (limit test) and was performed with Tri-N-Octylamine (CAS1116-76-3) (BASFSE, 1988, 10A0264/881077). Five male and five female Wistar rats were administered 2000 mg/kg bw test substance by gavage and observed for clinical signs of intoxication during the 14 days observation period.One male out of five rats and one female out of five rats, respectively, died on day 7 of the study. The other animals survived until the end of the observation period. While the male animals did not show any clinical signs of toxicity, the female rats showed dyspnoea, poor general state, spastic gait, piloerection and apathy. Necropsy revealed general congestion in the deceased animals and no abnormalities in the animals sacrificed at study termination.Under the conditions of the present study, the LD50 was determined to be greater than 2000 mg/kg bw.

 

Inhalation:

No valid information for trioctylamine on inhalation toxicity is available.

 

Dermal:

OECD conform studies:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats(5 males and 5 females)were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item Amines, tri-C8-10-alkyl to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours according to OECD guideline 402 (BASF SE, 2013, 11A0674/12X343). The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality occurred and no signs of systemic toxicity effects were observed. The following test item-related local effects were recorded during the course of the study:  Well-defined to severe erythema (grade 2 to 4),  very slight to severe edema (grade 1 to 4), incrustations and additionally, the local clinical signs were noted beyond the application site.Further the mean body weight of the animals decreased during the first post-exposure observation week, probably due to the severe skin reaction, but increased (only slightly in females) during the second week, but no macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw

Justification for classification or non-classification

Based on the available results above,no classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD-DPD) criteria.

Labelling for acute toxicity:

GHS: no classification

DSD-DPD: no classification