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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:
1985/11/05-1985/11/19
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts
EC Number:
272-723-1
EC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts
Cas Number:
68909-93-3
Molecular formula:
Too complex
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts
Details on test material:
Test substance from lot no. EC-47904 is described as pale amber viscous liquid with pH 5.34

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
3 male and 3 female rabbits supplied by Sgarlat's Rabbitry were acclimated to the laboratory for 5 days prior to study initiation. Apparently healthy rabbits were selected for the study and housed 1/cage in cages sized according to National Research Council standards. The rabbit rooms were maintained at 20 °C with humidity between 30-70% and 12 h light cycles. Wayne Rabbit Ration and tap water were freely available.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Test material was instilled into the conjunctival sac of one eye of each of the 6 rabbits. The lids were held together briefly to insure adequate distribution fo the material over the surface of the eye. The untreated eye of each rabbit served as a control.
Observation period (in vivo):
Ocular reactions were graded at 1, 24, 48, and 72 h and on Days 7, 14 and 21 after treatment
Number of animals or in vitro replicates:
6 (3 male, 3 female)
Details on study design:
An animal exhibited a positive response when the test substance produced one or more of the following signs: ulceration or opacity of the cornea, inflammation of the iris, or obvious swelling in the conjunctivae. Grading of irritation was according to the Draize system of scoring (1965)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.83
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.83
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.94
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
All rabbits scored positive for conjunctivae and chemosis by 1 h. Effects were fully reversible in all rabbits by Day 14. All rabbits scored positive for corneal effects by 24 h. Effects were fully reversible in all rabbits by Day 7. All rabbits scored negative for iritis.
Other effects:
no other effects reported.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test material produced a positive eye irritation response in New Zealand White Rabbits.
Executive summary:

In an eye irritation study, New Zealand White rabbits were treated with 0.1 ml of test substance for 4 h. Irritation responses were graded at 1, 24, 48, and 72 h and on Days 7, 14 and 21 after treatment. Positive scores for conjunctivae were observed immediately and were fully reversible by Day 14. Positive scores for corneal effects were observed by 24h and were fully reversible by Day 7. No observations of iritis were reported. Based on the results of this study, the test substance would be classified Category 2A in accordance with the classification system of GHS. This toxicity study is classified as acceptable and satisfies the guideline requirement for eye irritation study in rabbits.