Terphenyl

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.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 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Isaac's Farm, Litchfield, Illinois
- Age at study initiation: approximately 10 weeks (young adults)
- Weight at study initiation: 2.42 - 2.80 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum. Purina Rabbit Chow (Registered Trademark of the Ralston-Purina Company, St. Louis, Missouri) will be used.
- Water (e.g. ad libitum): ad libitum. Water will be furnished by the City of St. Louis, Missouri.
- Acclimation period: at least five days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

physiological saline

Details on dermal exposure:

TEST SITE
- Area of exposure: the dorsal surface
- % coverage: 10-30% of total body surface
- Type of wrap if used: The test material was held in place by means of an occlusive wrap of latex rubber secured by bandaging and elastic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The excess material was wiped from the animal.
- Time after start of exposure: The occlusive wrap was removed after approximately 24 hours

Duration of exposure:

24 hours

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 animals per dose per sex

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 during the first eight hours following test material administration 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 dermal 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:

> 5 000 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Effect levels 3

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No deaths were observed in animals of either sex.

Clinical signs:

other: All clinical abnormalities observed during this study were considered to result from direct contact between the test material and the skin in the exposed area. Erythema of the skin occurred in nine animals. The duration of this effect ranged from two to t

Gross pathology:

At necropsy, most of the findings reflected the effect of direct contact of the skin in the exposed area with the test material. Redness of the skin was observed in two male and three female animals. Areas of inhibited fur growth occurred in one male and two female rabbits. Hardened skin was observed in one male animal. Raised skin occurred in one female animal. One animal of each sex had defatted skin. Both kidneys of one male animal had pitted exteriors, but this was not considered to represent toxicity of the test material.

Any other information on results incl. tables

Acute Dermal Toxicity to Rabbits Mean Body Weight and Mortality Summary

Dosage (mg/kg)	Mean body weight (Kg)			N° deaths / N° dosed	Days of death postdosing
	Day 0	Day 7	Day 14
Male rats
5000	2.58	2.78	3.00	0/5	-
Female rats
5000	2.62	2.78	3.03	0/5	-

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 for MCS-1980 was determined to be above 5000 mg/kg bw.

Executive summary:

No deaths followed a dermal application of 5000 mg/kg bw of MCS-1980 to the shaved and abraed dorsal surface of albino of both sexes. Therefore, the acute dermal LD50 of this material is considered to be in excess of 5000 mg/kg. Clinical abnormalities included erythema, edema, and inhibited growth of fur in the exposed area.