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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-03-16 - 2004-05-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate test guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

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:
-
EC Number:
477-700-1
EC Name:
-
Cas Number:
883794-93-2
Molecular formula:
Hill formula: C18H36N2O6S2Si2 CAS formula: C18H36N2O6S2Si2
IUPAC Name:
1-{3-[(3-{2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecan-1-yl}propyl)disulfanyl]propyl}-2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: F.E.R., Italy
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 2 kg
- Housing: individually in stainless steel cages, 48x63x41 cm
- Diet (e.g. ad libitum): commercially available anti-biotic free pelleted laboratory diet
- Water (e.g. ad libitum): drinking water
- Acclimation period: 10 days before dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2
- Humidity (%): 55±15
- Photoperiod (hrs dark / hrs light): 24 h cycle of 12 h light/12 h dark

Test system

Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
The treated eye was examined macroscopically using the untreated eye as a comparator control.
The numerical scores obtained on assessing irritation at 24, 48 and 72 h examinations were summed and a mean calculated for each animal of the group.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max. observed score of 1 consistent at 24, 48 and 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: score of 0 observed after 1 hour
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: score of 0 observed after 1 hour
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: score of 0 observed after 1 hour
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max. observed score of 2 after 24 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: score of 1 observed after 1 hour
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: score of 1 observed after 1 hour
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: max. observed score of 2 after 24 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: score of 1 observed after 1 hour
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: score of 1 observed after 1 hour
Irritant / corrosive response data:
A slight redness and chemosis (score of 1) and a slight to well defined ocular discharge (score of 1 to 2) were noted in all animals at the 1 h examination. A well-defined conjunctival redness and chemosis (scores of 2), a slight ocular discharge (score of 1) and a slight corneal opacity (score of 1) were observed in 1 of the 3 animals at the 24 h examination, while a complete recovery had occurred in the remaining animals of the group. A slight redness (score of 1) and a slight corneal opacity were still present at the 48 and 72 h examination in the animal. Complete recovery occurred in the third animal at day 7 examination.
Other effects:
There was no indication of a systemic effect of treatment.
Changes in body weight during the course of the study were not remarkable.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not required