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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Terphenyl
EC Number:
247-477-3
EC Name:
Terphenyl
Cas Number:
26140-60-3
Molecular formula:
C18H14
IUPAC Name:
1,1':4',1''-terphenyl
Constituent 2
Reference substance name:
MCS-1980
IUPAC Name:
MCS-1980
Details on test material:
- Name of test material (as cited in study report): MCS 1980 (or Santowax CST)
- Molecular formula (if other than submission substance): C18H14 and C24H18
- Molecular weight (if other than submission substance): 230 and 306
- Physical state: brown solid
- Lot/batch No.: QET 1303369

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratory, Portage, MI
- Age at study initiation: Approximately 8 weeks (young adults)
- Weight at study initiation: 230-264 grams (males) and 166-200 grams (females)
- Fasting period before study: fasted overnight prior to test material administration
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum, except for overnight fasting prior to dosing. Purina Laboratory Rodent Chow (Registered Trademark of the Ralston-Purina Company, St. Louis, Missouri) will be used.
- Water (e.g. ad libitum): ad libitum, except for overnight fasting prior to dosing. Water will be furnished by the City of St. Louis, Missouri.
- Acclimation period: at least five days

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): The test material was administered as a 372 mg/ml suspension in corn oil. The volume administered was adjusted according to body weight and the dosage to be given.
Doses:
1984, 2500, 3150, 3969 and 5000 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for death and overt signs of toxicity were made three times within the first eight hours after dosing and twice daily (morning and afternoon) thereafter. Body weights were recorded on days 0 (day of dosing), 7, and 14.
- Necropsy of survivors performed: yes
Statistics:
The acute oral LD50 for each sex and for the combined sexes was calculated using the method of Finney [Finney, D.J., (1971). Probit Analysis (3rd edition). Cambridge University Press].

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 604 mg/kg bw
95% CL:
2 247 - 2 940
Sex:
male
Dose descriptor:
LD50
Effect level:
2 925 mg/kg bw
95% CL:
2 414 - 3 518
Sex:
female
Dose descriptor:
LD50
Effect level:
2 304 mg/kg bw
95% CL:
1 421 - 2 790
Clinical signs:
Toxicity to the nervous system was suggested by several of the clinical abnormalities that were observed during the early part of this study. Sedation, ptosis, and ataxia were each observed in at least 12 animals by the first day after dosing and each occurred in a dosage-related manner. Prostration and lacrimation also occurred, but these abnormalities were observed in fewer animals. Gastrointestinal involvement was indicated by diarrhea, but this may have been induced by the corn oil used as the dosing vehicle.
Gross pathology:
Necropsy findings of gastrointestinal (GI) distension, discoloration of the intestines, and apparent gastrointestinal hemorrhage indicated that the GI tract was affected by this test material.

Any other information on results incl. tables

Acute Oral Toxicity to Rats Mean Body Weight and Mortality Summary

Dosage (mg/kg)

Mean body weight (Grams)

N° deaths / N° dosed

Days of death postdosing

Day 0

Day 7

Day 14

Male rats

1984

247

301

352

0/5

-

2500

248

282

334

2/5

2,2

3150

251

278

326

2/5

1,2

3969

248

-

-

5/5

1,1,2,2,3

5000

238

-

-

5/5

1,2,2,2,2

Female rats

1984

181

210

235

1/5

1

2500

186

221

247

4/5

1,2,2,2

3150

179

209

228

4/5

1,2,2,2

3969

179

-

-

5/5

1,1,2,2,2

5000

174

-

-

5/5

1,1,1,2,2

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

When MCS 1980 was administered to fasted albino rats of both sexes, the acute oral LD50 was calculated to be 2604 mg/kg bw with 95% CL of 2247 -2940 mg/kg. For male rats, the acute oral LD50 was calculated to be 2925 mg/kg, and for female rates, it was calculated to be 2304 mg/kg bw. Observiations considered to be treatment related included sedation, ptosis, ataxia, prostration, lacrimation, and diarrhea. Ncecropsy findings indicated that the gastrointestinal tract was affected.