Terphenyl

Eye irritation

Administrative data

Endpoint:

eye 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other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Isaac's Farm, Litchfield, Illinois
- Age at study initiation: Approximately 10 weeks ( young adults)
- Weight at study initiation: 2.14-2.63 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (Purina Rabbit Chow O (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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A mass of 76 ± 2 mg determined to occupy a volume of 0.1 ml of test material

Duration of treatment / exposure:

single administration

Observation period (in vivo):

Signs of irritation were recorded on the first, second, and third days after dosing.

Number of animals or in vitro replicates:

3 animals per sex

Details on study design:

SCORING SYSTEM: Draize method

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.6

Max. score:

110

Reversibility:

fully reversible within: 2 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.06

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

< 0.2

Max. score:

3

Reversibility:

fully reversible within: 2 days

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

< 0.2

Max. score:

4

Reversibility:

fully reversible within: 2 days

Any other information on results incl. tables

Primary Eye Irritation to Rabbits Individual Irritation Scores

Animal n°	Obs. day	Cornea	Iris	Conjunctivae	Total	Average of 24, 48, 72 h
01M01	1	5	0	0	5	1.7
	2	0	0	0	0
	3	0	0	0	0
01M02	1	0	0	0	0	0.0
	2	0	0	0	0
	3	0	0	0	0
01M03	1	0	0	2	2	0.7
	2	0	0	0	0
	3	0	0	0	0
01F02	1	0	0	4	4	1.3
	2	0	0	0	0
	3	0	0	0	0
01F02	1	0	0	0	0	0.0
	2	0	0	0	0
	3	0	0	0	0
01F03	1	0	0	0	0	0.0
	2	0	0	0	0
	3	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

This key study for eye irritation is performed according to GLP and similar to OECD guideline 405, in which the Draize scoring system is used. New Zealand White rabbits were exposed to a single dose of 76 mg of test substance via the eye. Signs of irritation were recorded on the first, second and third day after dosing. Only on the first day signs of irritation were noted in 3 of the 6 test animals. By day 2, all animals were free of irritation signs.