Registration Dossier

Administrative data

Description of key information

Available studies gave the following results:
Oral LD50 (rat): 128 mg/kg bw
Dermal LD50 (rat): >= 2002 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
128 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 002 mg/kg bw

Additional information

Acute oral toxicity:

Only one study was available (Hazleton, 1985). It was with reliability 1 and was selected as key study. The summary of this study was the following:

In an acute oral toxicity study (Hazleton, 1985), groups of fasted, 6-7 weeks old Sprague-Dawley rats males and females (5/sex) were given a single oral dose of p-trifluoromethylaniline (purity >=98.5%) in arachid oil at doses 0, 100, 126, 156, 182, 195 mg/kg bw and observed for 14 days.
 Oral LD50 Combined = 128 mg/kg bw (111-149 mg/kg).
Based on these results, p-trifluoromethylaniline is considered as toxic by oral route and classified T R25 according to the 67/548/EC directive.

It is classified acute tox. Category 3 (H301), based on CLP criteria.

 

Acute dermal toxicity:

Only one study was available (Hazleton, 1986). It was with reliability 1 and was selected as key study. The summary of this study was the following:

In an acute dermal toxicity study (Hazleton, 1986), groups of young adult Sprague-Dawley rats males and females (5/sex) were dermally exposed to p-trifluoromethylaniline (>=98.5%) for 24 hours to lateral-dorsal at doses of 0, 2002 mg/kg mg/kg bw. Animals then were observed for 14 days.
 
Dermal LD50 Males = >2002 mg/kg bw
     Females = >2002 mg/kg bw
     Combined = >2002 mg/kg bw
Based on these results, p-trifluoromethylaniline is not classified by dermal route.

 

 

Acute inhalation study:

No data were available for p-TFMA. A read accross with m-trifluoromethylaniline was done.

One russian publication was available and was cited in Sax's Handbook and in HSDB database. The study was not well detailed because only a summary in english was given.

In this publication, the LC50 reported were0.44and 0.69 mg/L in rats and mice respectively.

One unpublished report (Hoechst GLP study, 1987) reported a LC50 range of 5.67 -6.29 mg/l air without more details.

Taking into account these values, p-trifluoromethylaniline could be classified as toxic T R23 by inhalation route, according to the EU classification criteria (67/548/EC directive) and acute category 3 (H331), according to CLP criteria because m-TFMA and p-TFMA are position isomers.

Justification for classification or non-classification

Based on available studies, p-TFMA could be considered as toxic by oral route and not harmful by dermal route, according to the EC classification criteria.

By analogy with m-TFMA, p-TFMA could be considered as toxic by inhalation route.