Terphenyl

Acute Toxicity: oral

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other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.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

Test material information

Constituent 1

Reference substance name:

Terphenyl

EC Number:

247-477-3

EC Name:

Terphenyl

Cas Number:

26140-60-3

Molecular formula:

C18H14

IUPAC Name:

2-phenyl-1,1'-biphenyl; 3-phenyl-1,1'-biphenyl; 4-phenyl-1,1'-biphenyl

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 levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 604 mg/kg bw

95% CL:

2 247 - 2 940

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

2 925 mg/kg bw

95% CL:

2 414 - 3 518

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

2 304 mg/kg bw

95% CL:

1 421 - 2 790

Clinical signs:

other: 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 occ

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.