Reaction mass of bisisopropyl peroxydicarbonate and bis-sec-butyl peroxydicarbonate and isopropyl-secbutylperoxydicarbonate

Endpoint summary

Description of key information

Acute oral toxicity data is not available for the reaction mass. The reaction mass is considered to have a worst case LD50 of > 2000 mg/kg bw based on results of the constituents 19910-65-7 (SBP) and 105-64-6 (IPP).

IPP has an oral LD50 >5000mg/kg bw (similar to OECD 401, 1983). The LD50 for SBP is 4640 mg/kg bw (similar to OECD 401, 1967). Since IBP is structurally very similar to IPP and SBP the acute oral LD50 is expected to be in the same range, as a worst case 2000 mg/kg bw is assumed as the LD50 for the purpose of calculation the LD50 of the multi -constituent. The toxicity is low for these substances. The acute oral toxicity of the stabilizer is 515 mg/kg bw (similar to OECD 401, 1981).

 

100/ATE_mix= 15/2000+ 6/5000 + 7/4640 + 72/515

ATE_mix= 667 mg/kg bw

 

According to CLP rulesthe classification of the mixture would be Acute oral toxicity category 4, harmful.

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:

weight of evidence

Study period:

1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No CoA, pre-GLP, only males, limited information on animals and conditions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

performed pre-GLP

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Charles River CD

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Females (if applicable) nulliparous and non-pregnant: not applicable
- Age at study initiation: no data
- Weight at study initiation: 151-186 grams
- Fasting period before study: yes
- Housing: metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: To: no data

Route of administration:

oral: gavage

Vehicle:

other: odorless mineral spirits

Details on oral exposure:

VEHICLE: odorless mineral spirits

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

DOSAGE PREPARATION (if unusual):
D-225 was maintained at -18C (0 Fahrenheit) until administered, at which time these were permitted to warm to a temperature of 10C (50 Fahrenheit) prior to dosing. The equipment used to administer these compounds (syringes, needles, beakers and diluent) were chilled to 10C (50 Fahrenheit) prior to use. Immediately after administering these compounds they were destroyed in accordance with the sponsor's instructions.

Doses:

100, 215, 464, 1000, 2150, 4640 mg/kg

No. of animals per sex per dose:

5 males

Control animals:

yes

Remarks:

vehicle controls

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- Other examinations performed: none

Statistics:

none

Sex:

male

Dose descriptor:

LD50

Effect level:

>= 4 640 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortalities occured

Mortality:

none

Clinical signs:

other: no data

Gross pathology:

no data

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 4640 mg/kg bw, no mortalities

Executive summary:

LD50 > 4640 mg/kg bw, no mortalities

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

June 23, 1983 to July 7, 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Version / remarks:

1982

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

The test article, Diisopropyl Carbonate (Lot number 287-1942), was a clear, colorless liquid supplied by the Sponsor. Records concerning the test article purity, source, and other data required in 21 CFR, 58.135 are the responsibility of the Sponsor and are not presented in this report.

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. (Portage, MI Facility), 251 Ballardvale Street, Wilmington, MA 10188
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: no data, young
- Weight at study initiation: 175-215g
- Fasting period before study: overnight before dosing
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.8-24.4
- Humidity (%): 52-62
- Air changes (per hr): no data, well ventilated and airconditioned
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: June 23, 1983 to July 7, 1983

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.2ml

Doses:

5 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were obseverd for mortality and other clinical signs each hour on day 0 and twice daily for the remainder of the study. Animals were weighed on day 0, 7 and 14.
- Necropsy of survivors performed: yes

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Mortality:

No mortality observed

Clinical signs:

other: Lethargy and ataxia were observed for all animals on the day of dosing and on the day following dosing for some animals. No stools were observed for 2 males and 4 females in the morning following dosing. Other abnormal clinical signs observed on the day o

Gross pathology:

Multiple stones in the urinary bladder and a moderately thickened urinary bladder were observed upon gross necropsy examination of one male. No other abnormalities were observed upon gross necropsy examinations of all animals, sacrificed on day 14.

Interpretation of results:

GHS criteria not met

Conclusions:

LD50> 5000 mg/kg bw, no mortalities observed.

Executive summary:

The test article, Diisopropyl Carbonate, was administered. by oral gavage to 5 male and 5 female albino rats at a dose level of 5 grams per kilogram of body weight to evaluate the acute oral toxic potential.. This study was designed to comply with procedures described in the EPA/OPP Guidelines, 1982. All animals survived the 14-day duration of the study and gained body weight. Lethargy and ataxia were observed for all animals on the day of dosing and. on the day following dosing for some animals. No stools were observed for 2 males and 4 females in the morning following dosing. Other abnormal clinical signs observed on the day of dosing included salivation (4 males), squinting (2 males), and crusty muzzle (2 males). No other abnormal clinical signs were observed during the study.

Multiple stones in the urinary bladder and a moderately thickened urinary bladder were observed upon gross necropsy examination of one male. No other abnormalities were observed upon gross necropsy examinations of all animals, sacrificed on day 14.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

WoE approach

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

Remarks:

comparable to guideline study with acceptable restrictions No CoA, pre-GLP, limited information on animals and conditions, only 2 animals used per each dose level, occlusive dressing, no necropsy, no data on individual animals.

Adequacy of study:

supporting study

Study period:

1970

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

performed pre-GLP

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

The test materials were received from the Lucidol Division, Pennwalt Corporation, Buffalo, New York, on June 12, 1970. It was received as a clear liquid packed in dry ice.

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: no data
- Age at study initiation: no data
- Weight at study initiation: 1810 - 2450 grams
- Housing: individually in hanging metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: To: no data

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: no data
- Type of wrap if used: occluded and wrapped with a gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tepid tap water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200 and 2000 mg/kg

Duration of exposure:

24 hours

Doses:

200 and 2000 mg/kg

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were measured initially and at 7 and 14 days after compound application.
- Necropsy of survivors performed: no

Statistics:

none

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All of the rabbits at each of the dosage levels tested survived the study period.

Clinical signs:

other: Twenty-four hours after application, erythema (very slight to moderate) and edema (slight to moderate) was observed at the site of application in each animal tested. Desquamation was noted during the 14 day observation period. Slight erythema remained in

Gross pathology:

Not applicable

Interpretation of results:

study cannot be used for classification

Conclusions:

None of the animals died at 2000 mg/kg bw, there were only 2 animals in each group. The study is not suitable for C&L purposes.

Executive summary:

None of the animals died at 2000 mg/kg bw, there were only 2 animals in each group. The study is not suitable for C&L purposes.

Endpoint conclusion

Quality of whole database:

No valid study available.

Justification for classification or non-classification

Acute oral toxicity data is not available for the reaction mass.The reaction mass is considered to have a worst case LD50 of > 2000 mg/kg bw based on results of the constituents 19910-65-7 (SBP) and 105-64-6 (IPP).

IPP has an oral LD50 >5000mg/kg bw (similar to OECD 401, 1983). The LD50 for SBP is 4640 mg/kg bw (similar to OECD 401, 1967). Since IBP is structurally very similar to IPP and SBP the acute oral LD50 is expected to be in the same range, as a worst case 2000 mg/kg bw is assumed as the LD50 for the purpose of calculation the LD50 of the multi -constituent. The toxicity is low for these substances. The acute oral toxicity of the stabilizer is 515 mg/kg bw (similar to OECD 401, 1981).

 

100/ATE_mix= 15/2000+ 6/5000 + 7/4640 + 72/515

ATE_mix= 667 mg/kg bw

 

According to CLP rulesthe classification of the mixture would be Acute oral toxicity category 4, harmful.