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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Reproductive toxicity study

Based on the data available from different studies, NOAEL for test material was considered to be 1000mg /kg bw/day.When male and female rats were treated with test material orally. Thus, comparing this value with the criteria of CLP regulation test material is not likely to classify as reproductive toxicant.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Data is Klimicsh 2 and from authoritative database
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Reproductive toxicity study

Data available from different studies were reviewed to determine the reproductive toxicity of test chemical.The studies are as mentioned below:

Study 1

In a Combined Repeat Dose and Reproductive / Developmental Toxicity Screening Test, Crj:CD(SD) male and female rats treated with test material in the concentration of 0 (vehicle), 100, 300, 1000 mg/kg orally by gavage for 42 to 47 days. No effect on survival of treated male and female rat was observed as compared to control. Red feces exhibiting the same color tone as the test substance administered in all sexes were observed daily from the day following the administration start date. At 1000 mg/kg bw, in 2 male loose stools were observed transiently on 22 days after the start of administration, but abnormalities in general conditions considered to be toxic changes. No significant effect on body weight and body weight gain and food consumption of treated male and female rats were observed as compared to control. Significant decrease in prothrombin time were observed in male rats at 100 mg / kg/day, but no change was observed in the 300 and 1000 mg / kg group, so it was judged to be an accidental change. In females, there was no significant difference between the test substances administered group and the control group. Significant increase in A / G ratio were observed in male rats. At 1000 mg / kg/day However, since the total protein and albumin were not changed and were slightly high, it was considered to be fluctuating within the physiological range and it was judged that it was not caused by administration of the test substance. Significant increase in ASAT (GOT) in female rats at 100 mg / kg/day, but no change was observed in the 300 and 1000 mg / kg group, so it was judged to be an accidental change. Similarly, No effect on reproductive parameters such as sexual cycle, mating index, the fertility index, numbers of corpora lutea or implantations, the implantation index, the delivery index, the gestation index, gestation length, parturition or maternal behavior, numbers of offspring or live offspring of treated rats as compared to control. Significant increase in relative liver weight in male and absolute and relative weight in female were observed at 1000 mg / kg bw as compared to control. Significant decrease in absolute spleen weight and significant increase in relative adrenal gland weight were observed at 300 mg / kg bw in male rats. Significant increase in relative adrenal gland weight were observed in male rats at 100 mg / kg bw. But, since there was no change in the 1000 mg / kg group, it was judged to be an accidental change. Colored stomach at 1000 mg / kg and red, colored contents were observed in small intestine and large intestine at 100 mg / kg. Focal bleeding of the lung, contraction failure and white spots, stomach tar-like contents, white spots of the liver, dilation of the renal pelvic cavity, uterine bloating, vaginal distension and ventricular dilation were observed. However, since there was no certain tendency in its expression status, it was judged to be an accidental change unrelated to administration of the test substance. No histopathological changes were observed in treated male and female rats as compared to control. In addition, No effect on numbers of live offspring, clinical signs and body weight of offspring were observed as compared to control. No gross pathological changes were observed in offspring. Therefore, NOAEL was considered to be 1000 mg/kg/day for P and F1 generation when Crj:CD (SD) male and female rats treated with test material orally by gavage for 42 to 47 days.

Study 2.

In reproductiveand developmental toxicity study , male and female charles river CDrats were treated wtih test materialin dose concentration 0,1000mg/kg orally. The test material mixed with basal diets. The animals were 35 days of age when treatment was initiated.After nine weeks of treatment, the animals were mated by pairing for seven days. The effect of test material for the in-utero phase was evaluated via mortality, clinical observations, body weight, food consumption, sex ratio, pup viability data and gross necropsy observations on selected animals. Compound consumption was judged to cause orange discoloration of the animals and their feces and an enlargement of their spleens during the in-utero and chronic phases. The chronic phase revealed non-neoplastic compound related effects which included a significant decrease in the red blood cell parameters (red blood cell count, packed cell volume and haemoglobin per cent) and an increase in the reticulocyte count observed after 3, 6, 12, 18 and 24 months of treatment. Compound consumption was judged to be associated with a significant increase in spleen weight, and the following non-neoplastic lesions of the spleen; extramedullary haematopoiesis, congestion, fibrosis, haemosiderosis, mesothelial hyperplasia, mesothelial cystformation, capsular fibrosis and multifocal cellular proliferations in the capsule. The accumulation of haemsiderin in some other organs of the treated rats also suggest a compound-related effect. The combination of decreased red cell parameters, reticulocytosis and haemosiderosis supports the hypothesis that there was a compound related decreased erythrocyte survival and a haematopoietic response to that decreased red cell survival. There was no evidence for an impairment of reproductive functions in animals.No effect on fertility indices, gestation anomalies, viability and survival of the pups were observed in treated rats as compared to control.Hence,NOAEL was considered to be 1000mg/kg bw/day as no effects on reproductive and developmental parameters were observed. When male and femalecharles river CDrats were treated wtih test materialorally.

Based on the data available from different studies test chemical did not showed reproductive toxicity at dose concentration 1000mg/kg bw/day.When rats were treated with test material orally.Hence the test chemical is not likely to classify as a reproductive toxicant as per the criteria mentioned in CLP regulation.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Thus, comparing this value with the criteria of CLP regulation test material is not likely to classify as reproductive toxicant.

Additional information