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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:
September 29 1982 to January 25 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, carried out according to recognised (older) guideline, results fully documented. Considered appropriate for use based on data available and animal welfare concerns.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Test consistent with Environmental Protection Agency's proposed guidelines, OECD guidelines and PR notice 81-3
Deviations:
no
Principles of method if other than guideline:
Stauffland albino rabbits were used for this eye irritation toxicity study. The eyes of the rabbits were examined at least 24 hours before application of the test substance for ocular and periocular abnormalities. Rabbits with preexisting ocular or periocular lesions or abnormalities were excluded from further ocular testing. One tenth of a milliliter of the test material was placed in the conjuctival sac of the left eye of each of nine rabbits. The treated eye was washed with water 20-30 seconds after exposure in 3 rabbits and the eyes were left unwashed in the remaining 6 rabbits. The untreated eye of each animal served as a negative control. The cornea, the iris and the bulbar and palpebral conjunctivae were observed at 1, 24, 48 and 72 hours and at 4 and 7 days after treatment. Observations with fluorescein staining were made 24 hours after the application of the test substance and until there was no staining for three consecutive observations. If irritation was present after 7 days, an additional observation was made every 3-4 days until the injury subsided or was found to be irreversible.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Fyrquel EHC (Trixylenyl phosphate)
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: not specified
- Physical state: liquid
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: #9221-J-1-1X
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified
- Storage condition of test material: not specified
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
other: Stauffland albino
Details on test animals or tissues and environmental conditions:
Animals used for this study were purchased from Phillips Rabbitry, Soquel, California. No details on environmental conditions are provided.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye served as control.
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
The treated eye was washed with water 20-30 seconds after exposure in 3 rabbits and the eyes were left unwashed in the remaining 6 rabbits.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
9 - 6 unwashed, 3 washed eyes.
Details on study design:
Stauffland albino rabbits were used for this eye irritation toxicity study. The eyes of the rabbits were examined at least 24 hours before application of the test substance for ocular and periocular abnormalities. Rabbits with preexisting ocular or periocular lesions or abnormalities were excluded from further ocular testing.

One tenth of a milliliter of the test material was placed in the conjuctival sac of the left eye of each of nine rabbits. The treated eye was washed with water 20-30 seconds after exposure in 3 rabbits and the eyes were left unwashed in the remaining 6 rabbits. The untreated eye of each animal served as a negative control. The cornea, the iris and the bulbar and palpebral conjunctivae were observed at 1, 24, 48 and 72 hours and at 4 and 7 days after treatment. Observations with fluorescein staining were made 24 hours after the application of the test substance and until there was no staining for three consecutive observations. If irritation was present after 7 days, an additional observation was made every 3-4 days until the injury subsided or was found to be irreversible.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No effects noted at 24 hours.
Irritation parameter:
overall irritation score
Basis:
animal #2
Remarks:
unwashed eye
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No effects noted at 24 hours.
Irritation parameter:
overall irritation score
Basis:
animal #3
Remarks:
unwashed eye
Time point:
other: 1 hour
Score:
6
Max. score:
6
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No effects noted at 24 hours.
Irritation parameter:
overall irritation score
Basis:
animal #4
Remarks:
unwashed eye
Time point:
other: 1 hour
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No effects noted at 24 hours.
Irritation parameter:
overall irritation score
Basis:
animal #5
Remarks:
unwashed eye
Time point:
other: 1 hour
Score:
6
Max. score:
6
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No effects noted at 24 hours.
Irritation parameter:
overall irritation score
Basis:
animal #6
Remarks:
unwashed eye
Time point:
other: 1 hour
Score:
6
Max. score:
6
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No effects noted at 24 hours.
Irritation parameter:
overall irritation score
Basis:
animal: #7 - washed eye
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 24
Remarks on result:
other: No effects noted at 24 hours.
Irritation parameter:
overall irritation score
Basis:
animal: #8 - washed eye
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 24
Remarks on result:
other: No effects noted at 24 hours.
Irritation parameter:
overall irritation score
Basis:
animal: #9-washed eye
Time point:
other: 1 hour
Score:
6
Max. score:
6
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No effects noted at 24 hours.
Irritant / corrosive response data:
In all rabbits, whether the eye was washed or unwashed after application, Fyrquel EHC (Trixylenyl phosphate) produced mild to moderate conjuctival irriatation. All irritation cleared within 24 hours.
Other effects:
None

Any other information on results incl. tables

Tabulated data is attached below; cannot be included within this section.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Fyrquel EHC (Trixylenyl phosphate) was a mild irritant in the eyes of albino rabbits. in all 9 rabbits tested, whether the eye was washed (3 rabbits) or unwashed after application (6 rabbits), Fyrquel EHC (Trixylenyl phosphate) produced mild to moderate conjuctival irriatation. All irritation cleared within 24 hours.
Executive summary:

Fyrquel EHC (Trixylenyl phosphate) was a mild irritant in the eyes of albino rabbits. in all 9 rabbits tested, whether the eye was washed (3 rabbits) or unwashed after application (6 rabbits), Fyrquel EHC (Trixylenyl phosphate) produced mild to moderate conjuctival irritation. All irritation cleared within 24 hours.

The substance is not classified as an eye irritant on the basis of the results. Initial irritation is rapidly overcome both by washing and by natural biological action.