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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:
9 Nov 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

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:
N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
EC Number:
221-336-6
EC Name:
N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
Cas Number:
3069-29-2
Molecular formula:
C8H22N2O2Si
IUPAC Name:
N-[3-[dimethoxy(methyl)silyl]propyl]ethane-1,2-diamine

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Sandbach, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 3.05 kg
- Housing: 1/suspended metal cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-18
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 1987-11-09 To: 1987-11-09

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not required - untreated eye is the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: neat
Duration of treatment / exposure:
30 mins. (Test animal sacrificed for humane reasons after 30 mins.)
Observation period (in vivo):
30 mins
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: not irrigated

SCORING SYSTEM: Draize (max 110)

TOOL USED TO ASSESS SCORE: light from standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 30 mins
Score:
85
Max. score:
110
Reversibility:
other: not possible to assess reversibility; unlikely to be reversible
Remarks on result:
other: one animal; observation 30 mins
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Remarks on result:
other: The test substance was tested on one animal only and demonstrated irreversible eye damage.
Irritant / corrosive response data:
Total score (one rabbit @ 30 mins): 85/110. Opalescent corneal opacity, iridial inflammation, severe conjunctival irritation. See table 1.
Other effects:
Conjunctival blood stained discharge and haemorrhage. Haemorrhage from nictitating membranes.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for a single animal (study terminated at 30 mins)

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Discharge

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

Max. score: 3

30 min

3

1

3

4

3

Area effected

 4

-

-

-

-

Total score 85/110

60/80

5/10

20/20 

Reversibility

Not possible to assess; unlikely to be reversible

 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
A reliable study, conducted according to OECD Test Guideline 405 and in compliance with GLP, reported corneal opacity, iridial inflammation and severe conjunctival irritation and a Draize score of 85 out of 110, in a single rabbit. The score was judged in the report to indicate that the test material was a very severe to extremely severe irritant to the eyes of rabbits, and would be considered to cause irreversible eye effects according to EU criteria.