OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate

Endpoint summary

Description of key information

Acute oral toxicity

The Acute oral toxicity of TBEC was evaluated in rats according to OECD N°401 guideline (Acute Toxic Standard Method). Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of 5000 mg/kg (Thouin, 1985). Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14). There was no mortality. Excepted diarrhea among most animals in the beginning of the study, no systemic toxicity was reported Body weight gain was normal. Macroscopic examination at necropsy revealed no gross abnormalities. Under these experimental conditions, the oral LD0 of TBEC was higher than 5000 mg/kg in Sprague Dawley rats.

 

TBEC evaluated for acute oral toxicity in male and female white Sprague-Dawley rats in a limit test similar to OECD 401 guideline (Reagan, 1985a). TBEC was administered by gavage to each of ten Sprague-Dawley rats (5 male, 5 female) at a level of 5.0 g/kg body weight. All animals survived the 15 day post-treatment observation period. Based on this result, the acute oral LD0 of TBEC was higher than 5.0 g/kg body weight.

 

Acute dermal toxicity

TBEC was evaluated for acute dermal toxicity in male and female white rabbits in a limit test similar to OECD 402 guideline (Reagan, 1985b). TBEC was applied to each of ten rabbits at a level of 2.0 g/kg body weight. There was noteworthy findings at necropsy. All animals survived the 15 day post-application observation period. Based on this result, the acute dermal LD0 of TBEC was higher than 2.0 g/kg body weight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffa Credo, Brussel, Belgium
- Young animals
- Weight at study initiation: 281.9 +-7 (male)/ 208.8+-8 (female)
- Fasting period before study: 12 hours before, and 4 hours after gavage
- Housing: individually in Macrolon cages
- Diet and water ad libitum
- Acclimation period: 6 days
- Quarantine period of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 25-70
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

5.405 mL/Kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Preliminary study:

Dose range finding study with one male and one female, at following doses: 1800, 2400, 3200, 4200, 5000 mg/kg : no mortality, no clinical signs excepted diarrhea, no gross abnormalities at necropsy.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: diarrhea for 9 animals the two first days

Gross pathology:

no effect

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD0 of TBEC more than 5000 mg/kg in Sprague Dawley rats.

Executive summary:

The Acute oral toxicity of TBEC was evaluated in rats according to OECD N°401 guideline (Acute Toxic Standard Method). Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of 5000 mg/kg. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14).

There was no mortality. Excepted diarrhea among most animals in the beginning of the study, no systemic toxicity was reported Body weight gain was normal. Macroscopic examination at necropsy revealed no gross abnormalities.

Under these experimental conditions, the oral LD0 of TBEC was higher than 5000 mg/kg in Sprague Dawley rats.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study, comparable to OECD 401 guideline. Raw data available. Nevertheless there is few data on the substance and no CoA.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

- Young adult Sprague­ Dawley rats were obtained from Charles River Breeding Laboratories, Inc., Wilmington, MA
- Animals were individually housed in wire mesh bottom cages in an environment-controlled room and were offered food and water ad libitum.
- After an acclimation period of at least 5 days, animals were assigned to the test.
- Animals were fasted overnight prior to receiving the dose

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

5.0 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

All animals were observed frequently on the day of dosing and twice daily for the remainder of the study.
All external signs of toxicity or pharmacological effects were noted.
Body weights were recorded initially, on days 8 and 15 or at death.
All animals that died during the study and those sacrificed at termination (day 15) were subjected to a gross necropsy and abnormalities were noted.

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: Ataxia: 0/5 male 2/5 female Decreased activity: 2/5 male 1/5 female Diarrhea: 4/5 male 4/5 female Wet abdomen: 0/5 male 2/5 female

Gross pathology:

No noteworthy findings

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

Under the experimental conditions, t-Butyl-2-Ethylhexyl-monoperoxycarbonate did not cause mortality in an acute oral toxicity test at 5.0 g/kg.

Executive summary:

t-Butyl-2 -Ethylhexyl-monoperoxycarbonate was evaluated for acute oral toxicity in male and female white Sprague-Dawley rats in a limit test similar to OECD 401 guideline.

The test article was administered by gavage to each of ten Sprague-Dawley rats (5 male, 5 female) at a level of 5.0 g/kg body weight. All animals survived the 15 day post-treatment observation period. Based on this result, the acute oral LD0 of the test article is considered to be greater than 5.0 g/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

Klimisch 1, GLP compliant.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP study, comparable to OECD 402 guideline. Raw data available. Nevertheless there is few data on the substance.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LaCrosse Industries, Inc., Schenectady, New York
- Age at study initiation: no data (young adults)
- Weight at study initiation: no data
- Housing: The rabbits were individually housed in wire mesh bottom cages in environment-controlled rooms and provided NIH 09 Rabbit Ration (Zeigler Brothers, Gardners, PA) and had water ad libitum
- Acclimation period: minimum of 5 days

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test article was administered to intact skin under an occlusive binder at a level of 2.0 g/kg body weight. The binder consisted of a layer of plastic wrap and stockinette sleeve all securely held in place with mask­ ing tape.

Duration of exposure:

24 hours

Doses:

2 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

After an exposure period of 24 hours, the binders were removed. The exposure sites were gently wiped with clean gauze to remove
as much non-absorbed test article as possible.
All animals were observed frequently on the day of dosing and twice daily thereafter for the remainder of the study.
All external signs of toxicity or pharmacological effects were noted. Necropsy was performed on all animals
Body weights were recorded initially, on days 8 and 15 or at death.

Statistics:

not applicable

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: Anorexia : 1/5 male and 0/5 female Diarrhea 1/5 male and 1/5 female Nasal discharge: 1/5 male and 0/5 female Soft stools: 1/5 male and 1/5 female

Other findings:

No noteworthy findings at necropsy

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, t-Butyl-2-Ethylhexyl-monoperoxycarbonate did not cause mortality in an acute dermal toxicity test at 2 g/kg.

Executive summary:

t-Butyl-2-Ethylhexyl-monoperoxycarbonate was evaluated for acute dermal toxicity in male and female white rabbits in a limit test similar to OECD 402 guideline. The test article was applied to each of ten rabbits at a level of 2.0 g/kg body weight.

There was noteworthy findings at necropsy. All animals survived the 15 day post-application observation period. Based on this result, the acute dermal LD50 of the test article is considered to be greater than 2.0 g/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

Klimisch 2, GLP compliant.

Justification for classification or non-classification

According to EU Regulation (EC) N0. 1272/2008 (CLP), TBEC is not classified for acute toxicity (oral, dermal and inhalation).