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Description of key information

Repeated dose toxicity: Oral

Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 1000mg/Kg bw using male and female rats. Hence the test chemical is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation.

Repeated dose toxicity: inhalation

According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical which is reported as  mm Hg. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver.

Repeated dose toxicity: dermal

The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Additional information

Repeated dose toxicity: Oral

Data available from experimental study report for the test chemicals was reviewed to determine the toxic nature of test chemical .The study as mentioned below:

In a Repeated Dose 28-day Oral Toxicity study, male and female Sprague Dawley rats were treated wtih test chemical in the concnetration of 0, 250 mg/kg, 500 mg/kg and 1000 mg/kg body weight orally by gavage in corn oil. Two additional dose levels were added to the study as control 0 mg/kg (Rev.) and test item 1000 mg/kg (Rev.), in order to study the reversibility or delayed occurrence of symptoms, if any.

No effect on survival, clinical sign, body weight, feed intake, Ophthalmoscopic examination and functional observation battery of treated male and female rats were noted at the end of dosing period of 28 days and the recovery period of 14 days. Similarly, at the end of the dosing period in male rat on day 29, revealed no statistically significant changes in the values of various parameters. Statistically significant increase in the values of MCHC at 1000 mg/kg were observed at the end of the recovery period. Statistically significant increase in the values of MCV and MCH and statistically significant decrease in the values of Total RBC and HCT at 500 mg/kg in female rats. No statistically significant changes in the values of various parameters at the end of the recovery period on day 43 in female rats. Statistically significant increase in the values of Total Bilirubin at 250 mg/kg in female rats, Statistically significant decrease was observed in the values of Aspartate Aminotransferase, Calcium and Gamma Glutamyl Transferase at 250 mg/kg in male rats as well as in Total Protein, Alanine Aminotransferase and Aspartate Aminotransferase at 1000 mg/kg in male, Calcium at 500 mg/kg in malerats, Gamma Glutamyl Transferase at 250 mg/kg in female rat, Calcium and Triglycerides at 250, 500 and 1000 mg/kg in female rats. were observed. In male at the end of the recovery period on day 43, no statistically significant changes in the values of various parameters. In female rats, statistically significant increase was observed in the values of Sodium and Chloride at 1000 mg/kg and statistically significant decrease was observed in the values of Total Protein, Globulin and Potassium at 1000 mg/kg. The increase/decrease in the values of various parameters was marginal and within the normal biological and laboratory limits. No abnormality attributable to the treatment except for higher volume of urine was observed in female animals at 1000 mg/kg reversal dose group and considered to be incidental and of no toxicological importance. Increased relative weights of liver at 500 mg/kg bw, decreased relative weights of spleen at 250 mg/kg and 500 mg/kg were observed in male rat as compared to control. Increased relative weights of liver, kidneys and heart at 250 mg/kg and increased relative weights of liver, kidneys and uterus were observed in female animals at 500 mg/kg as compared to control. Decreased relative weights of ovaries at 500 mg/kg and 1000 mg/kg and decreased relative weights of adrenals at 1000 mg/kg were observed in female rats as compared to control. On day 43 at 1000 mg/kg reversal group, increased relative weights of ovaries were observed as compared to controls. Although significant changes in the values of organ weight were observed in male and female animals from different dose groups, no related gross pathological and histopathological findings were seen, Hence these findings were considered to be of no toxicological importance. In addition, no Gross pathological and histopathological abnormality were observed in reproductive organ of treated male and femlae rats at the end of the dosing period on day 29 and recovery period on day 43 as compared to control. Therefore, No Observed Adverse Effect Level (NOAEL) of test chemical in the Sprague Dawley rata an oral route, over a period of 28 days was found to be 1000 mg/kg body weight in male and female animals.

Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 1000mg/Kg bw using male and female rats. Hence the test chemical is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation.

Repeated dose toxicity: inhalation

According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical which is reported as  mm Hg. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver.

Repeated dose toxicity: dermal

The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.

Justification for classification or non-classification

Based on the data available ,the test chemical is not likely to be toxic upon repeated exposure by oral, dermal and inhalation route of exposure and hence it is not likely to classify as a toxicant as per the criteria mentioned in CLP regulation.