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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:
29/06/1981 - 08/09/1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study according to EPA Guideline (Fed. Reg. 43:163, 37336-37402, 1978), and is consistent with OECD Guideline 405, 1981. Performed under QA. Diet and environmental conditions not reported. Acceptable basic data.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA Guideline for registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals, Fed. Reg. 43:163, 37336-37402, 1978
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
9 rabbits; exposure time
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Phosflex 72B
- Physical state: Liquid
- Composition of test material, percentage of components: confidential
- Lot/batch No.: confidential

Test animals / tissue source

Species:
rabbit
Strain:
other: Stauffland albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, California, USA

ENVIRONMENTAL CONDITIONS; No data

IN-LIFE DATES: No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (100%)
Duration of treatment / exposure:
3 rabbits: 20-30 seconds
6 rabbits: 7 days (unwashed)
Observation period (in vivo):
24, 48, and 72 hours, and at 4 and 7 days after treatment
Number of animals or in vitro replicates:
9
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with water in 3 rabbits (unwashed in the remaining 6 rabbits).
- Time after start of exposure: 20-30 seconds

SCORING SYSTEM: Numerical according to guidelines described by Draize (1965) (corneal, iridic and conjunctival irritation).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
other: 4 days
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
other: 4 days
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
other: 4 days
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
7 d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
washed and unwashed eyes
Basis:
mean
Remarks:
no irritation in any of the 6 animals tested
Time point:
7 d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
not measured
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
not measured
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
not measured
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
not measured
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
not measured
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Remarks:
not measured
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Phosflex 72B produced no irritation in rabbits whose eyes were left unwashed or in rabbits whose eyes were washed 20-30 seconds after treatment.
Other effects:
None

Any other information on results incl. tables

Not relevant

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Phosflex 72B was a non-irritant in the eyes of albino rabbits. This formulation produced no eye irritation in rabbits whose eyes were left unwashed or in rabbits whose eyes were washed 20-30 seconds after treatment. Based on the results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), Phosflex 72B does not have to be classified and has no obligatory labelling requirement for eye irritation.
Executive summary:

This eye irritation test, comparable to OECD Guideline 405, 1981, consists of a single instillation of 0.1.ml of the undiluted test material (Phosflex 72B) into one eye of each of 9 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 24, 48, and 72 hours, and at 4 and 7 days after treatment. The guidelines described by Draize (1965) were used to assign numerical scores to the observed effects and to develop a weighted total score for each animal for each day of observations. Phosflex 72B produced no irritation in the washed and unwashed eyes of albino rabbits. Based on the results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), Phosflex 72B does not have to be classified and has no obligatory labelling requirement for eye irritation.