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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:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to guideline. Restriction due to testing not performed under GLP. Data are of sufficient quality

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: 16CFR 1500.42- Federal Hazardous Substances Act Regulations
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts
EC Number:
270-478-5
EC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts
Cas Number:
68442-22-8
Molecular formula:
Too complex
IUPAC Name:
Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ace Animal, Inc, Boyertown, PA
- Housing: Stainless Steel caging with elevated wire mesh flooring, 1 rabbit/ cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6-23.9.
- Humidity (%):40 - 45%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: 18 April 1983 – 9 May 1983

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
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes
Observation period (in vivo):
The eyes were examined and graded for ocular reaction at 1, 2, 3, 4, 7, 14 days following instillation of test material into the eyes.
Number of animals or in vitro replicates:
6 rabbits.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing.
- Time after start of exposure: not applicable.

SCORING SYSTEM: Interpretation of the results was made in accordance with the Draize technique for scoring ocular lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 4, 72 hours
Score:
0.83
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: not reversible in 1/6 animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.6
Max. score:
2
Reversibility:
fully reversible within: day 14
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.8
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: not reversible in 3/6 animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2.9
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: not reversible in 4/6 animals

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test material causes irreversible effects on the eye
Executive summary:

In a primary eye irritation study, 0.1 ml of undiluted test substance was placed into one eye of each of the New Zealand White rabbits (6 animals).

 

The test substance produced ocular irritation up to 21 days.

The test substance is classified as Category 1 in accordance with the classification system of GHS

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