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Endpoint summary

Description of key information

Reaction mass of 2,4 -Dichloronitrobenzene and 2,6 -Dichloronitrobenzene is a multiconstituent substance containing
2,4 -Dichloronitrobenzene as main component which developednclear evidence of carcinogenic activity by 2 -year feeding  in both rats and mice.
The component 2,5-DCNB produced clear evidence of hepatocarcinogenicity in male rats and male and female mice and equivocal evidence of renal cell tumours and Zymbal gland tumor in male rats. Thus, reaction mass of 2,4-dichloronitrobenzene and 2,6-dichloronitrobenzene has to be evaluated as carcinogen. Morover,  based on the data on mutagenicity it has to be evaluated as genotocic carcinogen.

Additional information

Reaction mass of 2,4 -Dichloronitrobenzene and 2,6 -Dichloronitrobenzene is a multiconstituent substance containing

(611 -06 -3) 2,4 -Dichloronitrobenzene : 50 -80 %

(601 -88 -7) 2,6.-Dichloronitrobenzene: 10 -50 %

(89 -61 -2) 2,5 -Dichloronitrobenzene 0 -<1%

(541 -73 -1) 1,3 Dichlorobenzene 0 -5 %

mixture of 4,6 -dichloro-1,3 -dinitrobenzene and 2,4 -dichloro-1,3 -dinitrobenzene 0 -10 %

611 -06 -3

The test substance was studied for oral toxicity in an OECD combined repeat dose and reproductive/developmental toxicity screening test at doses of 0, 8, 40 and 200 mg/kg/day. With regard to repeat dose toxicity, a NOAEL of 8 mg/kg bw/day was established based on effects on liver, kidneys and blood. However, there are carcinogenicity studies according to OECD TG 451 and GLP available with rats and mice receiving diets containing 0 (control), 750, 1,500 and 3,000 ppm (w/w) for male and female rats and male mice and 0(control), 1500 and 3000 ppm for female mice, respectively, over a period of two years (Kano 2012). There was clear evidence of carcinogenic activity in liver and kidneys in both rats and mice (see chapter carcinogenicity).

601 -88-7

no data available

89 -61 -2

There are different oral studies in rats and mice over perieods of 14 days upto two years. The two year studies in rats and mice are performed according to OECD TG 453 (Repeat dose and carcinogenicity study) and GLP conditions. The animals received diets containing 0 (control), 320, 800 or 2000 ppm of 2,5 -DCNB over a period of 2 years. Chronic toxicity of 2,5-DCNB was characterized by centrilobular hypertrophy of hepatocytes in mice of both sexes, increased relative liver weight in rats of

both sexes, CPN with advanced severity in rats and decreased Hb and Ht accompanied by increased bone marrow hematopoiesis in female rats. However, 2,5-DCNB produced clear evidence of hepatocarcinogenicity in male rats and male and female mice, and equivocal evidence of renal cell tumors and Zymbal gland tumor in male rats.

541 -73 -1

Male and female Sprague-Dawley rats received 1, 3-dichlorobenzene (0, 9, 37, 147 and 588 mg/kg bw) daily by corn oil gavage for 90 days The authors did not establish a NOAEL since various parameters were significantly altered in all dose groups of both sexes

mostly relating to liver-, kidney- thyroid- and pituitary-toxicity

Mixture of 4,6 -dichloro-1,3 -dinitrobenzene and 2,4 -dichloro-1,3 -dinitrobenzene

There are no data on repeated dose toxicity available.

OVERALL CONCLUSION

Reaction mass of 2,4 -Dichloronitrobenzene and 2,6 -Dichloronitrobenzene is a multiconstituent substance containing

2,4 -Dichloronitrobenzene as main component which developed clear evidence of carcinogenic activity by 2 -year feeding in both rats and mice.The component 2,5-DCNB produced clear evidence of hepatocarcinogenicity in male rats and male and female mice and equivocal evidence of renal cell tumours and Zymbal gland tumor in male rats.

Thus, reaction mass of 2,4-dichloronitrobenzene and 2,6-dichloronitrobenzene has to be evaluated as carcinogen. Morover based on the data on mutagenicity it has to be evaluated as genotocic carcinogen.

Justification for classification or non-classification

See chapter carcinogenicity