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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:
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

1
Chemical structure
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
EC Number:
948-063-1
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

Resultsopen allclose all
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
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
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
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.