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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Value:
128 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
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.