3-(diethoxymethylsilyl)propylamine

Eye irritation

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:

other: This study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

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:

3-(diethoxymethylsilyl)propylamine

EC Number:

221-660-8

EC Name:

3-(diethoxymethylsilyl)propylamine

Cas Number:

3179-76-8

Molecular formula:

C8H21NO2Si

IUPAC Name:

(3-aminopropyl)diethoxymethylsilane

Details on test material:

- Name of test material (as cited in study report): D-1505
- Substance type: Alkoxysilane
- Physical state: Liquid
- Stability under test conditions: Not determined
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, UK
- Age at study initiation: 12-16 wk
- Weight at study initiation: 3.13 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 (%): 55
- 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:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml

Duration of treatment / exposure:

20 mins (Test animal sacrificed for humane reasons after 20 mins.)

Observation period (in vivo):

20 mins

Number of animals or in vitro replicates:

1 (due to severe reaction in first animal tested)

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

Results

Irritation parameter:

overall irritation score

Basis:

animal #1

Time point:

other: 20 mins

Score:

>= 98

Max. score:

110

Reversibility:

other: not possible to assess, presumably not reversible

Remarks on result:

other: one animal at 20 mins

Irritant / corrosive response data:

Total score (one rabbit @ 20 mins): >=98/110. Immediate translucent corneal opacity, green/brown discolouration of the nictating membrane and possible necrosis of the conjunctiva. At 20 mins: complete corneal opacity. See table 1.

Other effects:

At 20 mins: haemorrhage and green/brown discolouration of conjunctiva and nictating membranes, blood stained discharge and obvious pain.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data a single animal (study terminated at 20 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
20 min	4	?	3	3	3
Area effected	4	-	-	-	-
Total score >=98/110	80/80	?/10	18/20
Reversibility	Not possible to assess; unlikely to be reversible

  

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an eye irritation study, conducted according to OECD 405 and GLP (reliability score 1), complete corneal opacity at 20 minutes and a Draize score of >=98/110, in a single rabbit (due to the severity of the reaction no further animals were tested). The score was judged in the report to indicate that the test substance was a very severe to extremely severe irritant to the eyes of rabbits; it would be judged to cause irreversible eye effects according to EU criteria.