Terphenyl

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.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

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Draize, J. H., Woodard, G., and Calvery, H. 0. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes. J. Pharmacol. Exp. Thera p. 82: 377-390.

Deviations:

no

GLP compliance:

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

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: 2.16-2.60 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (Purina Rabbit Chow® (Registered Trademark of the Ralston-Purina Company, St, Louis, Missouri))
- Water (e.g. ad libitum): ad libitum (water furnished by the City of St. Louis, Missouri)
- Acclimation period: at least five days

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

physiological saline

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 0.5 ± 0.009 grams of the test material

Duration of treatment / exposure:

single exposure, 24 h exposure

Observation period:

The initial (day one) observation for skin irritation was made approximately one hour after the removal of the wrappings. Results were recorded at 24 and 72 hours after topical application. The animal that had irritation present during the 72 hour examination was also observed for signs of irritation on the seventh and tenth days after exposure.

Number of animals:

3 animals per sex

Details on study design:

TEST SITE
- Area of exposure: dorsal surface
- % coverage: The test material was applied to the skin under one inch square gauze patches
- Type of wrap if used: wrap of latex rubber secured by bandaging and elastic tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess material was wiped from the treated sites of the animals
- Time after start of exposure: aproximately 24 hours

SCORING SYSTEM: Dermal irritation was scored by the method of Draize (1944)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0.1

Max. score:

8

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: Intact and abraded skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: Intact skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0.13

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

other: Abraded skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: Intact and abraded skin

Irritant / corrosive response data:

All skin irritation had subsided by the tenth day after test material administration. Defatting of the skin on all four exposed sites occurred in one animal on the tenth day after exposure. No signs of systemic toxicity were observed.

Any other information on results incl. tables

Primary skin irritation score summary:

Period (days)	Erythema			Edema			Irritation score
	Intact	Abraded	Mean	Intact	Abraded	Mean
1	0.0	0.1	0.0	0.0	0.0	0.0	0.0
3	0.2	0.2	0.2	0.0	0.0	0.0	0.2

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The key study for skin irritation/corrosion is a K1 GLP study performed similar to OECD guideline 404, in which the Draize scoring system is used. New Zealand White rabbits were exposed to 0.5g of the test material for 24 hours under occlusive coverage upon both intact and abraded shaved skin. Subsequently, the excess material was wiped from the treated sites of the animals. Scorings were recorded 24 and 72 hours after topical application. Animals showing signs of irritation after 72 hours were further observed for signs of irritation on the seventh and tenth day after exposure. Only signs of slight erythema were observed.