Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 July 1994 - 8 September 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study; well documented study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Animals were not randomly selected for this study but were chosen based on pre-study ocular examination. This was a protocol deviation that did not impact on the study results.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts

EC Number:

270-608-0

EC Name:

Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts

Cas Number:

68457-79-4

Molecular formula:

{[(iso-C4H9O)0.64(C5H11O)0.36]PS2}2Zn - neutral, {[(iso-C4H9O)0.64(C5H11O)0.36]PS2}6Zn4O - basic

IUPAC Name:

Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) 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: Hazelton Research Products, Denver PA
- Age at study initiation: NO data available.
- Weight at study initiation: 2465- 2796 grams.
- Housing: individually in suspended Stainless Steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.7-21.1
- Humidity (%):40 - 60%
- Air changes (per hr): NO data available.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: 16 August 1994 – 8 September 1994

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 the conjunctival sac of one eye of the test animal. After instillation of the test material, the upper and lower lids were held closed for approximately 1 second to minimize loss of material. The contralateral eye was manipulated in an identical manner and served as an un-dosed 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, 7, 14 and 21 days following instillation of test material into the eyes.

Number of animals or in vitro replicates:

3 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. In addition, all treated eyes were examined following staining with sodium fluorescin at approximately 72 hours and on Days 7, 14, and 21 post treatment to detect corneal epithelial damage.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: day 21

Remarks on result:

other: not reversible in 3/3 animals

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.2

Max. score:

2

Reversibility:

fully reversible within: day 7

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

2.9

Max. score:

3

Reversibility:

fully reversible within: day 14

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: day 7

Irritant / corrosive response data:

The test material elicited moderate to severe ocular irritation that included corneal opacity, iritis, and conjunctival effects. Corneal opacity persisted in all three rabbits to Day 21.

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 conjuctival sac of one eye of each of the New Zealand White rabbits (3 animals).The test material elicited moderate to severe ocular irritation that included corneal opacity, iritis, and conjunctival effects. Corneal opacity persisted in all three rabbits to Day 21.

 

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