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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:
Date of Study Report: August 9, 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given : Comparable to quidelines/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: 16 CFR 1500.42
Deviations:
yes
Remarks:
: The test procedure was modified as follows: In Group I, Six rabbits; eyes unwashed following the instillation of the test material. In Group II, Three rabbits; eyes washed 4 seconds following instillation of the test material.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: Washout after 4s, no information on a preliminary in vitro study
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Diallyl Phthalate
- Other:
- Identified as No. C8013-3
- Specific gravity: 1.117-1.123 at 20°C/20°C
- Solubility in methanol: 1 cm³ in 5 cm³, clear-only slightly turbid
- Acidity as acetic acid, % by weight: 0.1 max
- Moisture(Karl Fischer): 0.1 max
- Color APHA Pt-Co: 90 max
- Odor: mild

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino
Details on test animals or tissues and environmental conditions:
The acute eye irritation test was determined on 9 young adult albino rabbits, selected from healthy, acclimated animals.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml or 0.1g
Duration of treatment / exposure:
Single application
Observation period (in vivo):
All eyes were observed and ocular reaction recorded at 24, 48, and 72 hours after instillation of the test material. They were observed again after 7 days.
Number of animals or in vitro replicates:
Group I: 6 rabbits with eyes unwashed following the instillation of the test material
Group II: 3 rabbits with eyes washed for 4 seconds following instillation of the tests material
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any or all eyes may be washed with sodium chloride solution U.S.P. or equivalent .
- Time after start of exposure: after the 24-hour reading.

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: Reading of reactions is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means. After the recording of observations at 24 hours, any or all eyes may be further examined after applying fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Groups I and II
Time point:
other: 24, 48, 72h, 7days
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Remarks:
Groups I and II
Time point:
other: 24, 48, 72h, 7days
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 2 from Group I ; 2 , 3 from Group II
Time point:
other: 24h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal: 3, 6 from Group I
Time point:
other: 24h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal: 3 from group I ; 1 from Group II
Time point:
other: 24h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritant / corrosive response data:
Group I : Conjunctival effects were observed in four animals. These effects cleared during the 72-hour observation period.
Group II : Conjonctival effects were observed in all three animals. These effects cleared during the 48-hour observation period.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
On the basis of the data presented herein the following is concluded for the test material, FMC Corporation; D.A.P. (1 Qt. Net Wt.); C-8013-3:
Group I and II: It is a mild transient irritant to the rabbit eye when not followed by or followed by a washout 4 -seconds after instillation of the test material.