Cyclohexylidenebis[tert-amyl] peroxide

Endpoint summary

Description of key information

Acute oral toxicity

The single-dose oral toxicity of Lupersol 531 -80M was evaluated in Sprague-Dawley rats (Douds, 1995a). A limit test was performed in which one group of five male and five female rats received a single oral administration of the test article at a dose of 5000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area. Body weight gain was noted for all animals during the test period. No significant gross internal findings were observed at necropsy on study day 14. Under the conditions of this test, the acute oral LD0 of Lupersol 531 -80M was estimated to be greater than 5000 mg/kg in the rat.

Acute dermal toxicity

The single-dose dermal toxicity of Lupersol 531-80M was evaluated in Sprague-Dawley rats (Douds, 1995b). A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area which occurred on study days 0 and 1. Dermal irritation was noted at the site of test article application. Body weight loss was noted for one female rat during the study day 0-7 body weight interval. Body weight gain was noted for all other animals during the test period. No gross internal findings were observed at necropsy on study day 14. Under the conditions of this test, the acute dermal LD0 of Lupersol 531 -80M was estimated to be greater than 2000 mg/kg in the rat.

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)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

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: Charles River Laboratories, Portage, Michigan
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: no data
- Weight at study initiation: males 215-234 g, females 207-235 g
- Fasting period before study: overnight
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rodent Chow #5002 (Purina Mills, lnc.) was provided ad libitum
- Water: Municipal tap water treated by reverse osmosis was available ad libitum
- Acclimation period: >= 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 62-70°F
- Humidity: 54-71%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg (5.56 ml/kg)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Clinical Observations
LD50 study animals were observed for clinical abnormalities two times on study day 0 (postdose) and daily thereafter (days 1-14). A general health/mortality check was performed twice daily (in the morning and in the afternoon).
- Body Weights
lndividual body weights were obtained for the LD50 study animals prior to fasting (day -1), prior to dosing on day 0 and for all surviving animals on days 7 and 14. Animals found dead after day 0 were also weighed.
- Gross Necropsy
All LD50 study animals which died spontaneously during the study or were euthanized by carbon dioxide inhalation at study termination (day 14) were necropsied. Body cavities (cranial, thoracic, abdominal and pelvic) were opened and examined. No tissues were retained.

Statistics:

The LD50 and 95% confidence intervals were calculated separately for males, females and the combined sexes using a computer adaption of the method of Litchfield and Wilcoxon.

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the limit test.

Clinical signs:

other: The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area.

Gross pathology:

No significant gross internai findings were observed at necropsy on study day 14.

Interpretation of results:

GHS criteria not met

Conclusions:

Linder the conditions of this test, the acute oral LD0 of Lupersol 531-BOM was estimated to be greater than 5000 mg/kg in the rat.

Executive summary:

The single-dose oral toxicity of Lupersol 531 -80M was evaluated in Sprague-Dawley rats. A limit test was performed in which one group of five male and five female rats received a single oral administration of the test article at a dose of 5000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area. Body weight gain was noted for all animals during the test period. No significant gross internal findings were observed at necropsy on study day 14. Under the conditions of this test, the acute oral LD0 of Lupersol 531 -80M was estimated to be greater than 5000 mg/kg in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

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: Charles River Laboratories, Portage, Michigan
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: no data
- Weight at study initiation: males 254-292 g, females 230-248 g
- Fasting period before study: no
- Housing: individually in suspended stainless steel cages
- Diet: PMI Certified Rodent Chow #5002 (Purina Mills, lnc.) was provided ad libitum
- Water: Municipal tap water treated by reverse osmosis was available ad libitum
- Acclimation period: a minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 64-74°F
- Humidity (%): 60-88
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure:
- % coverage: 10
- Type of wrap if used: plastic wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gauze moistened with distilled water followed by dry gauze
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Dermal Observations
Limit test animals were examined for erythema and edema following patch removal on study day 1 and daily thereafter (days 2-14) according to the Macroscopic Dermal Grading System provided in Protocol Appendix B which is based on Draize. The dermal test sites were reclipped as necessary to allow clear visualization of the skin.

Clinical Observations
Limit test animais were observed for clinical abnormalities three times on study day 0 (postdose) and daily thereafter (days 1-14). A general health/mortality check was performed twice daily (in the morning and in the afternoon).

Body Weights
lndividual body weights were obtained for the limit test animais prior to dosing on day 0 and on days 7 and 14.

Gross Necropsy
All limit test animals were euthanized by carbon dioxide inhalation at study termination (day 14) and necropsied. Body cavities (cranial, thoracic, abdominal and pelvic) were opened and examined. No tissues were retained.

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the limit test.

Clinical signs:

other: The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area which occurred on study days O and 1. Dermal irritation was noted at the site of test article application.

Gross pathology:

No gross internai findings were observed at necropsy on study day 14.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this test, the acute dermal LD0 of Lupersol 531-M80 was estimated to be greater than 2000 mg/kg in the rat.

Executive summary:

The single-dose dermal toxicity of Lupersol 531-80M was evaluated in Sprague-Dawley rats. A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area which occurred on study days 0 and 1. Dermal irritation was noted at the site of test article application. Body weight loss was noted for one female rat during the study day 0-7 body weight interval. Body weight gain was noted for all other animals during the test period. No gross internal findings were observed at necropsy on study day 14. Under the conditions of this test, the acute dermal LD0 of Lupersol 531 -80M was estimated to be greater than 2000 mg/kg in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Justification for classification or non-classification

According to CLP and GHS criteria:

No classification.