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EC number: 810-258-3 | CAS number: -
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Irritation / corrosion
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study for read-across substance performed according to established protocol.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Lehman, A.J. et al., in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc., Food and Drug Officials of the U.S., Second Printing, Topeka, Kansas 1965
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydrocarbons, C11-C14, isoalkanes, cyclics <2% aromatics
- IUPAC Name:
- Hydrocarbons, C11-C14, isoalkanes, cyclics <2% aromatics
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100%
- Duration of treatment / exposure:
- One-time treatment of one eye per rabbit
- Observation period (in vivo):
- Test animals observed at 1, 24, 48, and 72-hour, and 7 days.
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- Six New Zealand albino rabbits were used to determine the degree of ocular irritation resulting from the addition of the test material, Conoco LPA Solvent 8558-G, into the conjunctival sac of the animals.
The animals were individually housed in metal cages elevated above the droppings with feed, consisting of Purina Rabbit Chow and tap water freely available at all times.
Both eyes of each animals were examined with Fluoroscein Sodium Ophthalmic solution U.S.P. 4 hours before testing and only those animals without observable eye defects or irritation were used.
One-tenth milliliter of the test material was placed in one eye of each animals by gently pulling the lower lid away from the eyeball to form a cup into which the test material was deposited. The lids were then gently held together for one second and the animals was released. The other eye was not treated and served as a control. The eyes were not washed following instillation of the test material except as noted below. All animals were immobilized in a suitable animal restrainer for 1 hour subsequent to treatment.
The eyes were examined and the grade of ocular reaction was recorded at 1, 24, 48 and 72 hours and at 7 days, using the scale for scoring ocular lesions as outlined by Lehman, A.J. et al., in Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics Assoc., Food and Drug Officials of the U.S., Second Printing, Topeka, Kansas 1965. The evaluation of the data was in accordance with Section 191.12 Chapter 1, Title 21, Code of Federal Regulations under the FHSA.
After the initial examination at 24 hours all eyes were washed with sufficient clean tap water at body temperature to remove the residual test sample. All eyes were further examined by placing one drop of Fluorescein Sodium Ophthalmic solution U.S.P. on the cornea. After 5 minutes the excess fluoroscein was flushed out with sufficient tap water. Injured areas of the cornea appeared greenish yellow following application of fluoroscein.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- >= 0 - <= 5
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Within one hour, barely perceptible erythema of the palpebral and bulbar conjunctivae, chemosis of the lids and an accumulation of watery discharge (3 animals only). The erythema and discharge did not last 24 hours. The chemosis was present at a barely perceptible level in three test eyes for 72 hours. All animals were normal by 7 days. A maximum average score of 5.0 was recorded at 1 hour.
Any other information on results incl. tables
RESULTS:
Rabbit No. |
Structure |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
1 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
6 |
2 |
2 |
0 |
0 |
|
2 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
4 |
2 |
0 |
0 |
0 |
|
3 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
4 |
0 |
0 |
0 |
0 |
|
4 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
6 |
2 |
2 |
2 |
0 |
|
5 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
4 |
2 |
0 |
0 |
0 |
|
6 |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
6 |
2 |
2 |
2 |
0 |
|
Average |
5.0 |
1.7 |
1.0 |
0.7 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Reported results of cornea, iris, and conjunctivae scores for all six test animals do not meet the criteria for classification as an irritant.
- Executive summary:
Conoco LPA Solvent 8558 -G, when instilled undiluted into the conjunctival sac of six New Zealand albino rabbits and the treated eyes not washed following instillation of the test material, produced, within 1 hour, a barely perceptible to slight erythema, chemosis and water discharge (3 of 6 animals). This showed improvement throughout the study period. By 24 hours, the erythema had disappeared and only chemosis remained (5 of 6). By 72 hours only a barely perceptible chemosis remained in 3 of 6 test eyes. At 7 days, all test eyes were normal.
Mean corneal opacity, iritis, and conjuctivae scores for the test animals averaged over 24, 48, and 72 hours were insufficient to classify; therefore, the test material is considered not irritating.
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