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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
Started: may 21, 1979. Ended: june 9, 1980.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test method is similar to OECD Guideline 405. Deviations don't affect the reliability of the test.
Justification for type of information:
An Integrated Testing Strategy was performed so the information and data related to the substance of interest was gathered from scientific literature judged as relevant; a data could be judged as relevant even in the case an experimental study was performed to another substance but considered similar to the substance of interest.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Test protocol presented some differences about study design.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Lubricating oils, used
EC Number:
274-635-9
EC Name:
Lubricating oils, used
Cas Number:
70514-12-4
IUPAC Name:
Lubricating oils, used
Details on test material:
Test material was identified as API 79-7, Used Composite Motor Oil, CAS No. 70514-12-4 (Note: CAS No. was not assigned in original reference).

Gravity : 26,4 °API
Flash: 375 °F
Viscosity: 79,85 cSt 100°F
11,94 cSc 210°F
Pour: -45°F
Color: dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0,1 ml/animal.
Duration of treatment / exposure:
72 hours of exposure for six animals.
The eyes of three rabbits, two males and one female, were flushed for one minute with distilled warm water starting 30 seconds after the test material application.
Observation period (in vivo):
24, 48 and 72 hours after the test material application.
Number of animals or in vitro replicates:
5 males and 4 females.
Details on study design:
A dose of 0.1 ml of undiluted test material was placed on the everted lower lid of the right eye of each rabbit within the group.
The eyes of three rabbits, two males and one female, were flushed for one minute with distilled warm water starting 30 seconds after application of the test material. The untreated left eye of each rabbit was used as a control.
Scoring of ocular lesions was done at 24, 48 and 72 hours after treatment. Fluorescein dye evaluation was used for the 24 hour reading.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Unrinsed
Basis:
mean
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Unrinsed
Basis:
mean
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
Unrinsed
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
Unrinsed
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
Rinsed
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
Rinsed
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
Rinsed
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Mean irritation score was 0,33
Irritation parameter:
chemosis score
Remarks:
Rinsed
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Mean irritation score was 0,33
Irritation parameter:
conjunctivae score
Remarks:
Rinsed
Basis:
mean
Time point:
other: 48, 72 h.
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
Rinsed
Time point:
other: 48, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
One rabbit showed slight irritation at the 24 hour reading, all other rabbits had 0 as irritation score for the three readings.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to Regulation (CE) 1272/2008, the substance in order to be classified as irritant for the eyes has to fulfill the following requirements:
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 1 and/or
— iritis ≥ 1, and/or
— conjunctival redness ≥ 2 and/or
— conjunctival oedema (chemosis) ≥ 2
— calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days
Therefore, according to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, study results indicate that the substance should not be classified for eye irritation.

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