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Toxicological information

Acute Toxicity: oral

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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-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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; unthrifty coats, hypoactivity and oral discharge (salivation) in several animals; and nasal discharge, soft stool and apparently decreased food consumption in a few animals. Some animals exhibited alopecia, primarily of the ano-genital area, from Days 5 t o 14. This is probably related to the soft stool and fecal and urinary staining seen previously. Except for this observation, most animals were free of signs of toxicity from Day 6 through termination of the study (Day 14).
Body weight:
All animals gained weight during study. One female had a slight weight decrease (2g) at day 7 but gained weight between days 7 and 14 as expected.
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 Decreaseb

 

-

-

-

-/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.