Antimony, mixed dipentyldithiocarbamate and bis(2-ethylhexyl)dithiocarbamate complexes

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 April 1997 to 4 June 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

In-vivo study existed before in-vitro requirements were addressed with the regulation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Reaction mass of tris(dipentyldithiocarbamato-S,S')antimony and [bis(2-ethylhexyl)dithiocarbamato-S,S']bis(dipentyldithiocarbamato-S,S')antimony and bis[bis(2-ethylhexyl)dithiocarbamato-S,S'](dipentyldithiocarbamato-S,S')antimony and tris[bis(2-ethylhexyl)dithiocarbamato-S,S']antimony

IUPAC Name:

Reaction mass of tris(dipentyldithiocarbamato-S,S')antimony and [bis(2-ethylhexyl)dithiocarbamato-S,S']bis(dipentyldithiocarbamato-S,S')antimony and bis[bis(2-ethylhexyl)dithiocarbamato-S,S'](dipentyldithiocarbamato-S,S')antimony and tris[bis(2-ethylhexyl)dithiocarbamato-S,S']antimony

Test material form:

liquid: viscous

Specific details on test material used for the study:

- Description: Amber liquid
- Receipt date: 7 April 1997
- Expiration date: None provided

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: Adult
- Weight: Male: 2.722 kg; female ranges from 2.468 to 2.675 kg
- Housing: Housed individually in suspended stainless steel cages
- Diet (e.g. ad libitum): Certified rabbit feed was provided ad libitum throughout the study
- Water: Municipal tap water treated by reverse osmosis was available ad libitum throughout the study

- Acclimation period: A minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 70°F
- Humidity: 26 to 46%
- Air changes: 10-15 air changes/hour
- Photoperiod: 12-hour light/12-hour dark

IN-LIFE DATES:
- From April 1997 to May 1997

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml (dosed as supplied)

Observation period (in vivo):

1, 24, 48 and 72 hours

Details on study design:

TEST ANIMALS
- 1 male and 5 female adult New England White rabbits were utilised in the study

REMOVAL OF TEST SUBSTANCE
- Washing: Any residual test article was gently rinsed from the eye using physiological saline
- Time after start of exposure: 24 hours

SCORING SYSTEM
- Ocular Grading System based on Draize

TOOL USED TO ASSESS SCORE
- Fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Max. score:

0.11

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

other: conjunctival redness

Basis:

mean

Time point:

24/48/72 h

Max. score:

0.56

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

other: conjunctival edema

Basis:

mean

Time point:

24/48/72 h

Max. score:

0.28

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the test item has been determined to be non-irritant.

Executive summary:

An eye irritation study performed via a method that is comparable to the standardized guideline study OECD 405, under GLP conditions. Six (one male and five female) adult New Zealand White rabbits were dosed as the test material was supplied at 0.1 ml; the test item was instilled in the conjunctival sac of the right eye of each rabbit without washout. The other eye served as the untreated control.

The eyes were macroscopically examined with the aid of an auxiliary light source for signs of irritation at 1, 24, 48 and 72 hours after dosing according to the Ocular Grading System based on Draize. Following macroscopic observations at the 24 hour scoring interval, the fluorescein examination procedure was repeated on all test and control eyes and any residual test article was gently rinsed from the eye at this time (if possible) using physiological saline. Exposure to the test article produced iritis in 5/6 test eyes at the 1 hour scoring interval. The iridal irritation resolved completely in all affected lest eyes by the 48 hour scoring interval. Conjunctivitis (redness. swelling and discharge) was noted in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by the 72 hour scoring interval. Additional ocular findings included slight dulling of the normal luster of the cornea, which was noted in 3/6 test eyes.

Based on the EEC Ocular Evaluation Criteria, the calculated mean ocular irritation scores and irritation classifications of test item for corneal opacity, iris lesion, conjunctival redness and conjunctival edema were 0.00 (nonirritant), 0.11 (nonirritant), 0.56 (nonirritant) and 0.28 (nonirritant), respectively.