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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 one minute with lukewarm water starting 20-30 seconds after compound instillation
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vacuum Residuum (petroleum) API 81-14
- Substance type: Bitumen
- Physical State: Semi-solid, brown, tar like

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: 2502 to 2759 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

IN-LIFE DATES: From: 1981-12-15 To: 1981-12-22

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Contralateral eye served as untreated control for each rabbit
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 were gently held together for one second after compound instillation
Observation period (in vivo):
1, 24, 48, and 72 hours and 7 days
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Group II animals had the treated eye flushed for one minute with lukewarm water
- Time after start of exposure: 20 to 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)
Basis:
mean
Time point:
other: 1 hour
Score:
1
Irritation parameter:
other: Primary Eye Irritation Score (unwashed)
Basis:
mean
Time point:
other: 24 hours
Score:
4.7
Irritation parameter:
other: Primary Eye Irritation Score (unwashed)
Basis:
mean
Time point:
other: 48 hours
Score:
1.8
Irritation parameter:
other: Primary Eye Irritation Score (unwashed)
Basis:
mean
Time point:
other: 72 hours
Score:
0
Irritation parameter:
other: Primary Eye Irritation Score (unwashed)
Basis:
mean
Time point:
other: 7 days
Score:
0
Irritation parameter:
other: Primary Eye Irritation Score (washed)
Basis:
mean
Time point:
other: 1 hour
Score:
1.3
Irritation parameter:
other: Primary Eye Irritation Score (washed)
Basis:
mean
Time point:
other: 24 hours
Score:
3.3
Irritation parameter:
other: Primary Eye Irritation Score (washed)
Basis:
mean
Time point:
other: 48 hours
Score:
0
Irritation parameter:
other: Primary Eye Irritation Score (washed)
Basis:
mean
Time point:
other: 72 hours
Score:
0
Irritation parameter:
other: Primary Eye Irritation Score (washed)
Basis:
mean
Time point:
other: 7 days
Score:
0

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating under EU Dangerous Substances Directive 67/548/EEC or CLP.
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test material 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 one eye of 9 New Zealand White Rabbits. The other eye served as a control for each animal. Group II animals had the treated eye flushed, while group I did not.  Animals then were observed for 7 days. Irritation was scored by the method of Draize, 1959.

 

The mean primary irritation scores for the unwashed rabbits were 1.0, 4.7, 1.8, and 0 at 1, 24, 48, and 72 hours, respectively.  The mean primary irritation scores for the washed rabbits were 1.3, 3.3 0, and 0 at 1, 24, 48, and 72 hours, respectively. In this study, Vacuum Residuum is not an eye irritant.

 

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.