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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

Rat sub-chronic oral NOAEL = 45 mg/kg bw/day.

Rat chronic oral LOAEL = 25 mg/kg bw/day.

Mice chronic oral LOAEL = 30 mg/kg bw/day.

Key value for chemical safety assessment

Toxic effect type:

Additional information

EU Risk Assessment 2008:

There were not available studies in experimental animals following inhalatory or dermal exposure but several studies have been investigated the toxicity of 2-nitrotoluene following repeated oral administration to rats and mice. Most of feed studies were performed in essence according to OECD guidelines and in conformity with GLP and therefore selected for risk assessment.

Rat was the most susceptible species of the ones tested for repeated dose toxicity of 2- nitrotoluene.

In the 14-day studies (NTP, 1992), 2-nitrotoluene, administered up to 5000 ppm (mice) or 10000 ppm (rats), did not cause either effects on survival or clinical signs of toxicity, although 5000 ppm animals showed decreases in body weight gains relative to controls. In addition, a minimal oval cell hyperplasia in liver was observed only in 10000 ppm male rats. Therefore, 10000 ppm was selected the high concentration for 13-week studies.

At the 13-week toxicity studies, relative liver weights were increased from 625 ppm in both sexes of rats. However, at this dose level there was not treatment-related histopathology. Non- neoplastic lesions occurred at dose levels of 1250 ppm and above. Therefore, the NOAEL for subchronic-toxicity was considered to be 625 ppm (45 mg/kg b.w.) based on capsular fibrosis observed in spleen of male rats at 1250 ppm (89 mg/kg b.w.). In mice, the only histopathological lesion observed was degeneration and metaplasia of the olfactory epithelium in both sexes from 1250 ppm (223 and 268 mg/kg b.w. for males and females, respectively).

At the two-year carcinogenicity study, non-neoplastic lesions occurred at the lower dose level tested of 625 ppm in rats and 1250 ppm in mice. Therefore, the LOAEL for chronic toxicity was considered to be 625 ppm in rats (25 and 30 mg/kg b.w. in males and females, respectively) based on lesions observed in liver, bone marrow, spleen and lung for both sexes and in mammary gland and mandibular lymph node only for females.

Justification for classification or non-classification

Harmonised classification:

The substance has no harmonised classification for repeated dose toxicity according to the Regulation (EC) No. 1272/2008 (CLP). 



Based on the available information, no self-classification is proposed according to the CLP or the GHS for repeated dose toxicity.