2-tert-butylhydroquinone

Endpoint summary

Description of key information

Acute oral toxicity: 

 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity class IV.

 

Acute Inhalation Toxicity:

 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00144 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal toxicity:

 

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is between 200-1000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute dermal toxicity class IV.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Justification for type of information:

Data is from study report

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity of test chemical in rats

GLP compliance:

not specified

Test type:

standard acute method

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Not available

Route of administration:

oral: unspecified

Vehicle:

other: Jaguar

Details on oral exposure:

No other details available

Doses:

50-3200 mg/kg

No. of animals per sex per dose:

4

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Preliminary study:

not specified

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

951 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

50% mortality observed

Sex:

female

Dose descriptor:

LD50

Effect level:

1 131 mL/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

50% mortality observed

Mortality:

50% mortality observed at 951 mg/kg bw and 1131 mg/kg bw

Clinical signs:

other: Slight weakness

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

Toxicity Category IV

Conclusions:

The acute oral median lethal dose (LD50) of test chemical in male and female rat was found to be 951 and 1131 mg/kg of body weight respectively.

Executive summary:

Acute oral toxicity study of test chemical was conducted on male and female rats at the dose concentration of 951 and 1131 mg/kg bw. The test chemical was administered via oral unspesified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of slight weakness were observed. Therefore, LD50 value was considered to be 951 and 1131 mg/kg bw when rats were treated with test chemical via oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

951 mg/kg bw

Quality of whole database:

K1 level experimental data.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from study report

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute dermal toxicity of test chemical in guinea pig

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Type of coverage:

not specified

Vehicle:

water

Details on dermal exposure:

not specified

Duration of exposure:

24 hrs

Doses:

500-1000 mg/kg

No. of animals per sex per dose:

2

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Preliminary study:

not specified

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 500 - < 1 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No data available

Mortality:

Mortality observed between 700-1000 mg/kg bw dose level

Clinical signs:

other: Slight edema,staining and blister like spots. Scattered light eschars,sparse hair and some erythema at 1 wk. Light scars at 2 wks.

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

Toxicity Category IV

Conclusions:

The acute dermal median lethal dose (LD50) of test chemical in guinea pig was found to be >1000 mg/kg of body weight. Acute dermal toxicity of test chemical indicates that it is likely to exhibit acute toxicity by the dermal route in the Category 4.

Executive summary:

Acute dermal toxicity study of test chemical was conducted on guinea pigs at the dose concentration of 700 -1000 mg/kg bw. The test chemical was administered via dermal application. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of slight edema,staining and blister like spots, scattered light eschars,sparse hair, some erythema at 1 wk and Light scars at 2 wks were observed. Therefore, LD50 value was considered to be <1000 mg/kg bw when rats were treated with test chemical via dermal route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Quality of whole database:

K1 level experimental data.

Additional information

Acute oral toxicity:

 

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

 

1. Acute oral toxicity study of test chemical was conducted on male and female rats at the dose concentration of 951 and 1131 mg/kg bw. The test chemical was administered via oral unspesified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of slight weakness were observed. Therefore, LD50 value was considered to be 951 and 1131 mg/kg bw when rats were treated with test chemical via oral route.

 

2. Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 400 -3200 mg/kg bw. The test chemical was administered via oral unspesified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of slight weakness and vasodilation were observed. Therefore, LD50 value was considered to be 400 -3200 mg/kg bw when rats were treated with test chemical via oral route.

 

3.Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 615 (422 -895) mg/kg bw. The test chemical was administered via oral unspesified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of slight weakness and prostration were observed. Therefore, LD50 value was considered to be 615 (422 -895) mg/kg bw when rats were treated with test chemical via oral route.

4. Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 480 (352 -655) mg/kg bw. The test chemical was administered via oral unspesified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of slight weaknes, prostration and vasodilation were observed. Therefore, LD50 value was considered to be 480 (352 -655) mg/kg bw when rats were treated with test chemical via oral route.

5. Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 750 -950 mg/kg bw depending on the presence of food in the intestinal tract. The test chemical was administered via oral intubation route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of slight weaknes, prostration and vasodilation were observed. Therefore, LD50 value was considered to be 750 -950 mg/kg bw when rats were treated with test chemical via oral route.

6. Acute oral toxicity study of test chemical was conducted on male and female Sprague-Dawley rats at the dose concentration of 700 -1000 mg/kg bw. The test chemical was administered via oral unspecified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Therefore, LD50 value was considered to be <1000 mg/kg bw when rats were treated with test chemical via oral route.

 

Thus, based on the above summarized studies on test chemical, it can be concluded that LD50 value is between 200-1000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity class IV.

 

Acute Inhalation Toxicity:

 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00144 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal Toxicity:

 

In study report, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical . The study is summarized as below –

 

1. Acute dermal toxicity study of test chemical was conducted on guinea pigs at the dose concentration of 700 -1000 mg/kg bw. The test chemical was administered via dermal application. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Clinical signs of slight edema, staining and blister like spots, scattered light eschars, sparse hair, some erythema at 1 wk and Light scars at 2 wks were observed. Therefore, LD50 value was considered to be <1000 mg/kg bw when rats were treated with test chemical via dermal route.

Thus, based on the above summarized study on test chemical, it can be concluded that LD50 value is between 200-1000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute dermal toxicity class IV.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity and between 300-1000 mg/kg bw for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral and acute dermal toxicity class IV. For acute inhalation toxicity wavier was added so, not possible to classify.