N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 November 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

Test material information

Constituent 1

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:

(2-aminoethyl)({3-[dimethoxy(methyl)silyl]propyl})amine

Details on test material:

- Name of test material (as cited in study report): D-1411
- Physical state: a clear yellow coloured liquid
- Storage condition of test material: room temperature, in a glass screw-top bottle

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): 12/12

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 min (test animal sacrificed for humane reasons after 30 min)

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 Scoring System

TOOL USED TO ASSESS SCORE: light from standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 30 min

Score:

3

Max. score:

4

Reversibility:

other: not possible to assess reversibility because animal was sacrificed in humanity after 30 min of observation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 30 min

Score:

1

Max. score:

2

Reversibility:

other: not possible to assess reversibility because animal was sacrificed in humanity after 30 min of observation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 30 min

Score:

3

Max. score:

3

Reversibility:

other: not possible to assess reversibility because animal was sacrificed in humanity after 30 min of observation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 30 min

Score:

4

Max. score:

4

Reversibility:

other: not possible to assess reversibility because animal was sacrificed in humanity after 30 min of observation

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

animal was sacrificed in humanity after 30 min of observation

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

animal was sacrificed in humanity after 30 min of observation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

animal was sacrificed in humanity after 30 min of observation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

animal was sacrificed in humanity after 30 min of observation

Irritant / corrosive response data:

Total score (one rabbit @ 30 mins): 85/110. Opalescent cornal opacity, iridial inflamation, severe conjunctival irriation. See table 1.

Other effects:

Conjunctival blood stained discharge and haemorrhage. Haemorrhage from nicating 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:

other: CLP/EU GHS criteria are met, Category 1 (irreversible effects on the eye) classification required according to Regulations (EC) No 1272/2008

Conclusions:

A reliable study, conducted according to OECD 405 and GLP, reported corneal opacity, iridial inflamation 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.