Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine

Endpoint summary

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) for test chemical was considered based on experimental study, the value considered to be >2000 mg/kg bw in rat. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute oral toxicity.

Acute Inhalation toxicity:

For test chemical, acute toxicity testing by the inhalation route was considered for waiver given that the substance has low vapour pressure of 0.0000004 Pa at 25oC as well as the particle size distribution indicates that the majority particle size is between 150 - 600 micro meter. Thus, exposure by inhalation is also unlikely for test chemical given the comparitively larger size of the particulates.

Acute Dermal toxicity:

The acute dermal toxicity dose (LD50) for test chemical was considered based on experimental study, the value considered to be >2000 mg/kg bw in rat. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The data is K1 level.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

The data is K1 level

Additional information

Acute toxicity oral:

Acute Oral Toxicity Study of test chemical in Rats, was conducted. This study was performed as per OECD No. 423.Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs.Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and no mortality was observed. Hence, further dosing was stopped.Body weights were re­corded on day 0 (prior to dosing) 7 and 14. Mean body weight of all the animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0.At 2000 mg/kg, all the animals were normal throughout the experimental period.

No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice.

Thus considering the CLP Criteria for classification of the substance, it is concluded that test chemical did not exhibit acute toxicity to rat by the oral route.

Acute toxicity inhalation:

For test chemical, acute toxicity testing by the inhalation route was considered for waiver given that the substance has low vapour pressure of 0.0000004 Pa at 25oC as well as the particle size distribution indicates that the majority particle size is between 150 - 600 micro meter. Thus, exposure by inhalation is also unlikely for test chemical given the comparitively larger size of the particulates.

Acute toxicity dermal.

Acute Dermal Toxicity Study of test chemical inWistar Rats.This study was performed as per OECD No.402.Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Ratsfree from injury and irritation of skin were selected for the study. Approximately, twenty four hours prior to dermal application of test item, greater than 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment.

On test day 0, anamount of test item moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area.This porous gauze dressing was covered with a non-irritating tape.After the 24-hour application period, the dressings were removed and theskin was gently wiped with distilled water.The skin reactions were assessed.

The animals were observed daily for mortality and clinical signs, during the acclimatization period and post dosing till the termination. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14.All animals were necropsied and examined macroscopically.No mortality was observed in any animal till the end of the experimental period.At 2000 mg/kg, all the animals were normal throughout the experimental period.Mean body weight of male and female animals was observed with gain on day 7 and 14 as compared to day 0

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Thus considering the CLP Criteria for classification of the substance, it is concluded that test chemical could not exhibit acute toxicity to rat by the dermal route

Justification for classification or non-classification

Based on the above experimental studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute oral and dermal toxicity. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute oral and dermal toxicity. For acute inhalation toxicity wavier were added so, not possible to classify.