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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:
From19 Feb 1996 to 1 Mar 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
EC Number:
260-350-7
EC Name:
4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
Cas Number:
56706-10-6
Molecular formula:
C18H42O6S2Si2
IUPAC Name:
4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
Constituent 2
Reference substance name:
S2
IUPAC Name:
S2

Test animals / tissue source

Species:
rabbit
Strain:
other: White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ASTA Medica AG, GERMANY

- Age at study initiation: 24, 60 months (males); 20 months (female)

- Weight at study initiation: 2.41-2.55 kg (male); 2.76 kg (female)

- Housing: 1/cage

- Diet (e.g. ad libitum): standard diet, ad libitum

- Water (e.g. ad libitum): drinking water, ad libitum

- Acclimation period: at least 1 day


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 19.0-20.0

- Humidity (%): 50-84

- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: Not stated

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: none required - other eye used as control
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit) 0.1 ml

- Concentration (if solution): neat
Duration of treatment / exposure:
No washout (examinations: 1, 24, 48, 72 h)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (2 males, 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): no washing reported

SCORING SYSTEM: Draize 1944, 1994; OECD 404

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein: 'pencil light'

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness, chemosis, discharge
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
7.3
Max. score:
20
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score of 3.66 (redness 1 + chemosis 0.66 + discharge 2) is multiplied by 2 giving 7.3
Irritation parameter:
cornea opacity score
Remarks:
redness, chemosis, discharge
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24 h
Score:
1.3
Max. score:
20
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score of 0.66 ( 0.66 + 0 + 0) is multiplied by 2 giving 1.3
Irritation parameter:
overall irritation score
Remarks:
irritation index
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Irritation index 2/110 was deemed in this study to indicate no irritation (Gilman et al. 1983).

Any other information on results incl. tables

The test material did not cause significant ocular lesions, in two or more animals, as indicated by any of the following:

corneal opacity =>2...<3

iris lesion =>1...=<1.5

conjunctival redness =>2.5

conjunctival oedema (chemosis) =>2

based, in each case, on mean values for each animal derived from readings at 24, 48 and 72 h.

(EU criteria).

There were no irridial or corneal effects.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae redness

Conjunctival chemosis

Conjunctivae discharge

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

Max score 3

60 min

0,0,0

0,0,0

1,1,1

1,1,0

2,2,2

24 h

0,0,0

0,0,0

0,1,1

0,0,0

0,0,0

48 h

0,0,0

0,0,0

0,0,0

0,0,0

0,0,0

72 h

0,0,0

0,0,0

0,0,0

0,0,0

0,0,0

Average 24h, 48h, 72h

0

0

0.2

0

0

Area effected

0

-

-

-

-

Maximum average score (including area affected, max 110; 24, 48, 72 h)

0/80

[corneal opacity x area x 5]

0/10

[iris score x 5]

0.4/20

[(redness + chemosis + discharge) x 2]

 

Reversibility*)

n/a

n/a

c

c

c

Average time (unit) for reversion

 -

48 h

24 h

24 h

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Gilman, M. R., Jackson E. M., Cervernm, D. R., Moreno, M. T. (1983). Relationship between the primary dermal irritation index and ocular irritation. J. Toxicol-Cut & Ocular Toxicol; 2: 107-117.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A reliable study conducted in accordance with the standard guideline and GLP found the test material to be not irritating to the eyes of rabbits.