Registration Dossier

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 according to or similar to guideline study OECD 405.

Data source

Reference
Reference Type:
study report
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)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
68334-30-5
Cas Number:
68334-30-5
IUPAC Name:
68334-30-5
Constituent 2
Reference substance name:
Diesel fuel -marketplace sample
IUPAC Name:
Diesel fuel -marketplace sample
Test material form:
other: low viscosity hydrocarbon liquid
Details on test material:
- Name of test material (as cited in study report): API #79-6, disel fuel (marketplace sample)
- Substance type: petroleum distillate product composed of hydrocarbon chains
- Physical state: liquid
- Analytical purity: not provided by sponsor
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components wt percent: 41.7% paraffins, 30.9% cycloparaffins (monocycloparaffins 18.8% dicycloparaffins 9.3%, tricycloparaffins 2.8%) 27.4% aromatics (alkylbenzenes 8.4%, indans and tetralins 5.3%, dinaphthenobenzenes 1.1%, C11+ naphthalenes 7.6%, biphenylenes 2.5% fluorenes etc 1.1% tricyclic aromatics 1.4%)
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported by sponsor
- Storage condition of test material: stored in Elars' test material storage room
- Flash Point: 142 °F
- Sulfur 0.19%
- Viscosity at 100°F: 2.17 cSt
- Bromine number 1.42
- benzene 80 ppm v/v
- acid number 0.0
- Distillation range (ASTM D-86) 5-95%: 412-648 °F
- Initial BP: 367 °F
- Final Boiling Point: 675°F

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: L.I.T. Rabbitry
- Age at study initiation: young adult
- Weight at study initiation: 2 to 4 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported


IN-LIFE DATES: not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye was left untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
- Concentration (if solution): no vehicle
- Lot/batch no. (if required): no vehicle
- Purity: no vehicle
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
24, 48, and 72 hours
Number of animals or in vitro replicates:
4 males and 5 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test eye of three rabbits were flushed with distilled water
- Time after start of exposure: 30 seconds


SCORING SYSTEM: Draize method


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Remarks on result:
other: unrinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Remarks on result:
other: unrinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
20
Remarks on result:
other: unrinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: included within conjunctivae score
Irritant / corrosive response data:
No signs of occular lesions were present. All rabbits scored zero on every point at each observation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study, exposure of the test material to the eyes of rabbits did not cause any occular lesions. The test material is not classified as irritating to the eye.
Executive summary:

In an eye irritation study, 4 male and 5 female New Zealand White rabbits were exposed to test material diesel fuel (marketplace sample). 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 test eyes of three rabbits, two females and one male, were flushed for one minute with distilled warm water starting 30 seconds after application of the test material. The test eyes of the remaining 6 rabbits were unwashed. The untreated left eye of each rabbit served as a control. Occular lesions were scored at 24, 48, and 72 hours after treatment. Fluorescein dye evaluation was used for the 24 hour reading. Scoring was done in accordance with the Draize technique.

No signs of ocular lesions were present. All rabbits scored zero on every point at each observation. The test material is not classified as irritating to the eye.

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