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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: This study is classified as reliable without restriction because it was conducted similar to guideline study OECD TG 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Group II animals had the treated eye flushed for 1 minute with lukewarm water starting 30 seconds after compound instillation.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: semi-solid
Details on test material:
- Name of test material (as cited in study report): Vacuum Residuum (Petroleum), API 81-13
- Substance type: Bitumen
- Physical state: Semi-solid
- Other: Very thick, dark brown liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratories, Inc., Denver, PA
- Weight at study initiation: 2810 to 3130 g
- Housing: Individually in screen bottom cages
- Diet (e.g. ad libitum): Ad libitum (continuous access to Purina certified rabbit chow)
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22
- Humidity (%): 46 to 60
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Contralateral eye remained untreated as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of test material (as supplied)
Duration of treatment / exposure:
Eyelids held together for 1 second after compound instillation
Observation period (in vivo):
1, 24, 48, and 72 hours and at 7 days after treatment
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group II animals had treated eye flushed for one minute with lukewarm water.
- Time after start of exposure: 30 seconds after compound instillation

SCORING SYSTEM: Draize, 1959

TOOL USED TO ASSESS SCORE: Sodium Fluorescein and ultraviolet light were used to aid in revealing possible corneal injury

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Primary Eye Irritation Score (unwashed group)
Basis:
mean
Time point:
other: 24 hours
Score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: Primary Eye Irritation Score (unwashed group)
Basis:
mean
Time point:
other: 48 hours
Score:
4.2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
other: Primary Eye Irritation Score (unwashed group)
Basis:
mean
Time point:
other: 72 hours
Score:
1.8
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
other: unwashed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.6
Max. score:
10
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1.2
Max. score:
12
Remarks on result:
other: unwashed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.6
Max. score:
8
Remarks on result:
other: unwashed
Other effects:
Hypoactivity, possible anorexia, a bloated appearance and diarrhea was observed in one group I animal at the 7-day observation. The clinical signs exhibited by this animal are not considered treatment related.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating under EU CLP (EC 1272/2008).
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, Vacuum Residuum is considered not irritating to the rabbit eye.
Executive summary:

In a primary eye irritation study, 0.1 mL of Vacuum Residuum was instilled into the conjunctival sac of the right eye of 9 New Zealand White Rabbits. Group II animals had the treated eyey flushed 30 seconds after compound instillation, while Group I animals remained unflushed.  Animals then were observed for 7 days. Irritation was scored by the method of Draize, 1959.

Primary eye irritation scores for the unwashed eyes at 1, 24, 48, and 72 hours were 2.0, 4.0, 4.2, and 1.8, respectively. Primary eye irritation scores for the washed eyes at 1, 24, 48, and 72 hours were 1.3, 5.3, 2.0, and 0.7, respectively.  In this study, Vacuum Residuum is considered not irritating to the rabbit eye based on low primary eye irritation scores which were fully resolved by day 7.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted similar to guideline study OECD TG 405.