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Administrative data

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/ATEmix= 15/2000+ 6/5000 + 7/4640 + 72/515

ATEmix= 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

Referenceopen allclose all

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:
no data
Body weight:
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

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:
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.
Body weight:
All animals gained body weight
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:
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 evidence on the 14th day following application of the test material.
Body weight:
All animals exhibited normal gains in body weight during the period of study.
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.

Additional information

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/ATEmix= 15/2000+ 6/5000 + 7/4640 + 72/515

ATEmix= 667 mg/kg bw

 

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