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Diss Factsheets

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:
28.02.1992 to 21.07.1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
animal husbandry - minor excursions from recommended relative humidity
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethoxypropylsilane
EC Number:
219-842-7
EC Name:
Triethoxypropylsilane
Cas Number:
2550-02-9
Molecular formula:
C9H22O3Si
IUPAC Name:
triethoxy(propyl)silane

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, Halle-Kűnsebeck, GERMANY
- Age at study initiation: Males: 8 or 12 months; Females: 6 months
- Weight at study initiation: Males: 2.47, 2.49 kg; Females: 2.33 kg
- Housing: 1/ cage. Stainless steel cage with grating floor.
- Diet: standard diet approximately 120 g/day
- Water: drinking water ad libitum
- Acclimation period: at least 1 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 (briefly to 22.5)
- Humidity (%): 50-70 (briefly to 74). The Guideline recommends a maximum of 70%.
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 /12

IN-LIFE DATES: From: 10 March 1992 to 20 March 1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL (neat)
Duration of treatment / exposure:
Single application without washing; study terminated for last animal after 6 days.
Observation period (in vivo):
1, 24, 48, 72 hours, then daily to day 4 (2 animals) or 6 (1 animal).
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : no washing

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: pencil light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: mean out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
iris score
Basis:
other: mean out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable.
Irritation parameter:
conjunctivae score
Basis:
other: mean out of animal #2 and #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
other: mean out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
The test material was transiently irritant, see table 1.
Scored at 24, 48 and 72 h it was clear that 2 of 3 animals did not achieve scores that would be indicative of irritation.
Other effects:
There were no systemic effects.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time

Score at time point / Reversibility

Cornea

Iris

Conjunctivae - redness

Conjunctivae- chemosis

Conjunctivae - discharge

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

Max. score 3

60 min

0/0/0

1/0/0

3/1/2

3/1/1

3/3/3

24 h

0/0/0

0/0/0

2/1/1

1/0/0

1/0/0

48 h

0/0/0

0/0/0

2/1/1

0/0/0

0/0/0

72 h

0/0/0

0/0/0

1/1/0

0/0/0

0/0/0

Average 24 h, 48 h, 72 h

0/0/0

0/0/0

1.7/1/0.7

0.3/0/0

0.3/0/0

Average score (including area affected, max 110)*

0

0.4

5.3

Reversibility**

n/a

c

c

c

c

Maximum time for reversion

n/a

24 h

6 days***

48 h

48 h

* Scoring ocular lesions: as given in report, based on 1, 24, 48, 72 h

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

*** Conjunctival redness was still evident in one animal at day 4.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
In an eye irritation study conducted according to OECD 405 and in compliance with GLP (reliability score 1), triethoxypropylsilane was transiently irritating, with a Draize score of 6 out of 110, and it was therefore concluded that the test substance is not irritating to the eyes.