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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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)
EC Number:
224-235-5
EC Name:
Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)
Cas Number:
4259-15-8
Molecular formula:
Too complex
IUPAC Name:
1-Hexanol, 2-ethyl-, O,O-diester with phosphorodithioic acid, zinc salt

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 2.38 to 2.64 kg
- Housing: Housed individually in wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-26.1
- Humidity (%): 40-70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light


IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution):


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Number of animals or in vitro replicates:
9 (6 rinsed, 3 unrinsed)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): for 3 animals rinsed for one minute 200 ml of lukewarm tapwater
- Time after start of exposure: 30 seconds


SCORING SYSTEM:
Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 hour
Score:
1.17
Reversibility:
not reversible
Remarks on result:
other: Non-rinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hour
Score:
0.6
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Non-rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2.17
Reversibility:
not reversible
Remarks on result:
other: Non-rinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
Score:
2.67
Reversibility:
not reversible
Remarks on result:
other: Non-rinsed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0.33
Reversibility:
fully reversible
Remarks on result:
other: Rinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: Rinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.55
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Rinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.44
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Rinsed

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
According to the study conducted, Phosphorodithioic acid, O,O-bis(2-ethylhexyl) ester, zinc salt causes persistent eye irritation through 21 days. Rinsing the test material out of the eyes 30 seconds after the exposure resulted in eye irrtation that was reversible within 21 days.