Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

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.