Residues (petroleum), distn. residue hydrogenation

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: 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

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

Test material information

Constituent 1

Reference substance name:

Vacuum residue (CAS # 64741-56-6)

IUPAC Name:

Vacuum residue (CAS # 64741-56-6)

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

Results

Results 1

Irritation parameter:

other: Primary Eye Irritation Score (unwashed)

Basis:

mean

Time point:

other: 1 hour

Score:

1

Results 2

Irritation parameter:

other: Primary Eye Irritation Score (unwashed)

Basis:

mean

Time point:

other: 24 hours

Score:

4.7

Results 3

Irritation parameter:

other: Primary Eye Irritation Score (unwashed)

Basis:

mean

Time point:

other: 48 hours

Score:

1.8

Results 4

Irritation parameter:

other: Primary Eye Irritation Score (unwashed)

Basis:

mean

Time point:

other: 72 hours

Score:

0

Results 5

Irritation parameter:

other: Primary Eye Irritation Score (unwashed)

Basis:

mean

Time point:

other: 7 days

Score:

0

Results 6

Irritation parameter:

other: Primary Eye Irritation Score (washed)

Basis:

mean

Time point:

other: 1 hour

Score:

1.3

Results 7

Irritation parameter:

other: Primary Eye Irritation Score (washed)

Basis:

mean

Time point:

other: 24 hours

Score:

3.3

Results 8

Irritation parameter:

other: Primary Eye Irritation Score (washed)

Basis:

mean

Time point:

other: 48 hours

Score:

0

Results 9

Irritation parameter:

other: Primary Eye Irritation Score (washed)

Basis:

mean

Time point:

other: 72 hours

Score:

0

Results 10

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.