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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
EC Number:
240-212-2
EC Name:
4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
Cas Number:
16068-37-4
Molecular formula:
C14H34O6Si2
IUPAC Name:
4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology, Löhndorf, GERMANY
- Age at study initiation: 2.5-3.5 months
- Weight at study initiation: 1.6-1.9 kg
- Housing: 1/cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 55 +/-15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 2002-04-29 To: 2002-05-03

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye is the control in each case.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: neat
Duration of treatment / exposure:
Single exposure, unwashed. Exposure until end of study (72 h).
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: unwashed

SCORING SYSTEM: After Draize, as given in OECD 405

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other: each of 3 animals
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
13
Reversibility:
fully reversible within: 24 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Minor (grade 1) corneal redness and chemosis in 1 of 3 animals at 1 h. No corneal or iridial effects. No other observations.
Other effects:
None.

Any other information on results incl. tables

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

Conjunctival redness

Conjuctival chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

0/0/0

1/0/0

1/0/0

24 h

0/0/0

0/0/0

0/0/0

0/0/0

48 h

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

Average 24h, 48h, 72h

0/0/0

0/0/0

0/0/0

0/0/0

Reversibility*

-

-

c

c

Average time (unit) for reversion

-

-

24 h

24 h

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

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A reliable study, conducted according to OECD 405 and GLP, reported transient irritation - grade 1 corneal redness and chemosis at 1 h. The mean score (24, 48, 72 h) was 0/13 and 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane was found to be not irritating to the eyes of rabbits.