2,3-xylidine

Endpoint summary

Description of key information

Study of Tomonori Enami et. al, Gotemba Laboratory,Bozo Research Center Inc., 1284, Kamado, Gotemba-shi, Shizuoka, 412, Japan 
2,3-Dimethylaniline was studied for oral toxicity in rats in a 28-day repeat dose toxicity test at doses of 0, 12, 60 and 300 mg/kg. 
The NOEL is considered to be 12 mg/kg/day for males and less than 12 mg/kg/day for females.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

12 mg/kg bw/day

Study duration:

subchronic

Species:

rat

Additional information

The study report is only available in japanese language, therefore not all informations can be given here. The study was made under GLP-conditions and the datas available from abstract confirm that the study can be valued as reliable without restrictions.

Citation original text of abstract:

"A temporary decrease in food consumption was noted in males given 300 mg/kg during the early period of administration.

On urinalysis, decreases in pH and specific gravity and increases in bilirubin, occult blood, RBC and WBC in urinary sediment, water intake and urine volume in both sexes given 300 mg/kg, an increase in small round epithelial cells in urinary sediment in males given 300 mg/kg and an increase in urinary protein in females given 300 mg/kg were observed. Hematological and blood chemical changes associated with methemoglobinemia were noted in both sexes given 60 and 300 mg/kg. Spleen weights were increased and gross enlargement was evident in both sexes given 300 mg/kg and histopathologically, heavy deposits of hemosiderin in red pulp in females given 12 mg/kg and both sexes given 60 and 300 mg/kg, increased extramedullary hematopoiesis in both sexes given 300 mg/kg and congestion in males given 300 mg/kg were noted. Kidney weights were increased in both sexes given 300 mg/kg and histopathologically, papillary necrosis, dilatation of renal tubules and cellular infiltration in cortical interstitium in both sexes given 300 mg/kg, basophilia of renal tubules, mineralization of inner medulla and a high incidence of eosinophilic bodies in males given 300 mg/kg and hyaline casts in males given 60 mg/kg and females given 300 mg/kg were noted. Liver weights were increased in females given 60 mg/kg and both sexes given 300 mg/kg and histopathologically, hypertrophy of centrilobular hepatocytes, bile duct proliferation, deposits of hemosiderin in Kupffer cells and extramedullary hematopoiesis were apparent in both sexes given 300 mg/kg. In the bone marrow, increased hematopoiesis was noted in both sexes given 60 and 300 mg/kg. Almost all changes, except for those in the kidney, disappeared or were diminished after a 14-day recovery period. The NOEL is considered to be 12 mg/kg/day for males and less than 12 mg/kg/day for females."

Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys

Justification for classification or non-classification

Study supports the EU classification of STOT RE 2 H373, target organ Kidney.