3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-11-05 to 1984-11-08

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Two test animals were used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Two animals were used.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

EC Number:

219-588-7

EC Name:

3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Cas Number:

2469-55-8

Molecular formula:

C10H28N2OSi2

IUPAC Name:

3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: the test substance was applied undiluted
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kuiper's Rabbit Ranch, Indiana
- Age at study initiation: young adults
- Weight at study initiation: 3798 - 3892 g at study initiation
- Housing: individual hanging wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322
- Water (e.g. ad libitum): not specified
- Acclimation period: 69 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): The test material was applied undiluted.

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

one male and one female rabbit

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): unwashed
- Time after start of exposure: single instillation

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Max. score:

4

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

4

Max. score:

4

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Puruloid discharge, petechiea, blanching and eschar present on palpebral conjunctiva were observed in all the animals at 24, 48 and 72 h observation period.

Other effects:

Not specified.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

In the eye irritation study, conducted according to a protocol similar to OECD 405 with acceptable restrictions and in compliance with GLP, the test material 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine, was concluded to be Category 1 eye irritant.