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Toxicological information

Eye irritation

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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other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
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

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 / 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

Resultsopen allclose all
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
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
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
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
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.