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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
Study period:
From April 23, 1990 to May 24, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report in agreement with OECD guideline 405-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
increased number of animals
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydrocarbons, C10, aromatics, >1% naphthalene
EC Number:
919-284-0
Cas Number:
Not applicable
Molecular formula:
None available - not a single isomer - see remarks
IUPAC Name:
Hydrocarbons, C10, aromatics, >1% naphthalene
Details on test material:
- Name of test material (as cited in study report): MRD-89-523
- Physical state: colorless liquid
- Lot/batch No.: Batch I
- Analytical purity: assume purity 100%
- Stability under test conditions: Not documented. Material stable under normal conditions
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research
- Age at study initiation: Approximately 14 weeks
- Weight at study initiation: 2.29-2.75 kg
- Housing: Individual
- Diet (e.g. ad libitum): restricted feeding regimen per manufacturers recommendation
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): maintained range of 18.3-21.1 °C
- Humidity (%): maintained range of 40-60%
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 1990-05-08 To: 1990-05-22

Test system

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

Duration of treatment / exposure:
Test material was introduced into the lower conjunctival sac of the right eye of each animal. The upper and lower lids were gently held together for one second prior to releasing to prevent loss of material
Observation period (in vivo):
1, 24, 48, 72 hours post-instillation and once per day on days 4, 7, 10, and 14
Number of animals or in vitro replicates:
Six animals (all females)
Details on study design:
SCORING SYSTEM: Draize Method


TOOL USED TO ASSESS SCORE: 2% sodium fluorescein dye under UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h, 48h, 72h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h, 48h 72h
Score:
ca. 1.46
Max. score:
8
Reversibility:
fully reversible within: 14 days
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 1h
Score:
ca. 1.17
Max. score:
2
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 24h
Score:
ca. 0.5
Max. score:
1
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 48h
Score:
ca. 0.17
Max. score:
1
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 72h
Score:
ca. 0.6
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1h
Score:
ca. 1.67
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72h
Score:
ca. 0.2
Max. score:
1
Reversibility:
fully reversible within: 14 days
Other effects:
Alopecia around the treated eye was noted for one animal on days 10 and 14.

One animal died prior to study termination (day 3). This animal exhibited poor food consumption, distended abdomen, and small amount of stool on day 2. It was the opinion of the study director that this death was not test material related, but due to a gastro-intestinal problem.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

Application of 0.1ml of MRD-89-523 to the eye of six rabbits elicited slight, transient conjunctival redness, chemosis, and some discharge.  Mean scores for redness at 24, 48, 72 hours were 0.50, 0.17, and 0.60 respectively.  The scores for chemosis were 1.67, 0, and 0.  There were no positive scores for corneal, or iridial irritation.  Ocular irritation was most prominent at the 1 hour, 72 hour and day 4 observations where the total Draize score ranged from 4-12.  Additional observations included alopecia in one animal on days 10 and 14.  All other animals were free of signs of irritation within 14 days of dosing.  Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.