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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts
EC Number:
288-917-4
EC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts
Cas Number:
85940-28-9
Molecular formula:
C23.H50.O4.S4.P2.Zn
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts
Details on test material:
- Physical state: liquid
- Analytical purity: 100%
- Effective substances: solution of Zn-dialkyldithiophosphate (about 80%) in mineral oil (about 20%)
- Batch No.: 205 92 08
- Expiration date: May 1993
- Stability under test conditions: stable at dry storage

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kurt Meckel, Laubach-Ruppertsburg, Germany
- Weight at study initiation: 3096 - 3221 g
- Acclimation period: 5 days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3; 2 males, 1 female
Details on study design:
The animals were acclimatized for 5 days prior to the application. 24 h prior to the application all rabbits were checked to detect eye lesions. No defects were determined.
The test substance was undilutedly applied in a single dose of 0.1 mL into the right eye to each of 3 albino rabbits. To this end, the substance was placed to the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. 24 h after application the eye was carefully rinsed with NaCl 0.9 % in order to remove the residual test substance. The left eye was not treated and was used for control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: male
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: male
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: female
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: male
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: male
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: female
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: female
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: male
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: male
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.6
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: female
Irritant / corrosive response data:
After the administration none of the rabbits showed signs of ocular lesions or irritations of the cornea or of the iris.
After evaluation of the eye reaction, all three animals had hyperaemic blood vessels graded at grade 2. Hyperaemic blood vessels were not observed any more on day 11 (animals # 2 and 3) and on day 13 (animal # 1).
All rabbits showed swelling of lids estimated at grade 1 (animal # 2) and at grade 2 (animals # 1 and 3).
All three animals showed exsudation at the time of 24, 48 and 72 h after administration.
The effects on conjunctivae were reversible which was revealed by the last 2 days of observation.
No pathological changes were observed in the control (left) eyes.
Other effects:
Mortality: none of the rabbits died during the experiment.
Toxicological symptoms: none of the animals showed toxicological signs.
Behaviour: The reaction of the animals treated was quiet and watchful. The behaviour pattern was normal.
Body weight: The body weight of all animals had a normal physiological growth. All animals had an increase in weight.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to EU classification (Directive 67/548/EEC), the substance does not meet the criteria for classification.
However, according to GHS classification, the substance has to be classified as irritating to eyes, Cat. 2A.