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EC number: 247-477-3 | CAS number: 26140-60-3
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- other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.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:
- 1 981
- 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
- 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
- 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
Constituent 1
Constituent 2
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.
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