Benzene, ethylenated, by-products from

Acute Toxicity: oral

Administrative data

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:

other: Well conducted and reported study according to the standard guideline

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

Test substance: MCS-2170
Physical state: Yellow Liquid
Reference Number: NBP-2532690-B
Stored at Room Temperature
Density 0.97 g/ml

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratory
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 301-325 g (males) 236-260g (females)
- Fasting period before study: overnght (approx 18 hours)
- Housing: Individually hosed during study in stainless steel cages
- Diet: ad libitum Purina Laboratory Chow
- Water: ad libitum
- Acclimation period: 16 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 67-76 Deg Farenheit
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h day/night cycle

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Adminstration via a ball tiped gavage needle. Doses calculated using fasted body weights. Dose volume 5.2 ml/kg.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observations made approximately 1, 2, and 4 hours after dosing thereafter every day, 2 times per day.
Body weights taken at start of study and on day 7 and 14.
All animals surviving to day 14 were sacrificed (Carbon Dioxide inhalation)
Gross examinations performed, abnormalities recorded but no tissues saved.

Statistics:

Not applicable

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no mortality observed

Mortality:

All animals survived

Clinical signs:

other: Most animals were free of abnormalities on the day of dosing, although a few exhibited wet rales or nasal discharge. However, a number of unusual signs were seen beginning on the day after dosing. These included urinary and fecal staining in most animals;

Gross pathology:

Gross postmortem observations were similar to those seen in control animals in this laboratory or were considered to represent normal physiological variation.

Other findings:

Not applicable

Any other information on results incl. tables

DOSE: 5000 mglkg

SUMMARY OF PHARMACOLOGIC AND TOXICOLOGIC SIGNS

 

 

Day				1	2	3	4	5	6	7	8	9	10	11	12	13	14
Hour	1	2	4	24
Observation	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F	M/F
Nasal Discharge	-/1	-	-	1/1	-	1/-	-	-	-	-				-		-	-
Oral Discharge (salivation)	-	-	-	4/1	2/-	1/-	-	-	-	-	-	-	-	-	-	-	-
Met Rales	-	1/1	1/1	1/1	-/1	-	-	-	-			-	-	-		-	-
Urinary Staining	-	-	-	4/5	2/1	-	-	-	-	-	-	-	-	-		-	-
Fecal Staining	-	-	-	4/2	2/1	-	-	-	-	-	-	-	-	-
Unthrifty Coat	-	-	-	3/-	4/4	4/5	2/2	2/1	-			-	-	-	-	-
Soft Stool	-	-	-	1/1	-/1	-	-	-	-	-	-	-	-	-	-	-	-
Alopecia	-	-	-	-	-	-	-	-/1	1/2	-/3	-/3	¼	2/4	2/4	2/4	2/4	3/4
Hypoactivity	-	-	-	2/2	2/2	1/2	-	-	-	-	-	-	-		-
Food Consumption Decrease^b	-	-	-	-/1	-/1	2/2	1/2	-	-	-	-	-	-	1/-	-	-	-
Lesion Right Hind Leg	-	-	-	-	-	1/-	1/-	1/-	1/-	1/-	1/-	1/-	-	-	-	-	-

aNumbers represent number of males and females(M/F),out of 5 per sex which exhibited signs one or more times during interval.

bVisua1 assessment; no food consumption measurements made.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The Oral LD50 value of this substance is >5 g/kg bw.