Aspartic acid, N-[3-(trimethoxysilyl)propyl]-, 1,4-diethyl ester

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

diethyl N-[3-(trimethoxysilyl)propyl]aspartate

EC Number:

606-274-3

Cas Number:

192389-48-3

Molecular formula:

C14H29NO7Si

IUPAC Name:

diethyl N-[3-(trimethoxysilyl)propyl]aspartate

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Sex: male
- Source: LPT Laboratory of Pharmacology and Toxicology KG, 24601 Löhndorf, Germany
- Age at study initiation: approx. 6.5 months
- Weight at study initiation: 2.2-2.6 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the left eye, which remained untreated, served as control

Amount / concentration applied:

Amount: 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48, 72 hours post application

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not specified

SCORING SYSTEM: according to DRAIZE

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1,2,3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: mean score after 72 hours: 0.0

Results 2

Irritation parameter:

iris score

Basis:

animal: #1,2,3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: mean score after 72 hours: 0.0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1,2,3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: mean score after 72 hours: 0.0

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1,2,3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: mean score after 72 hours: 0.0

Any other information on results incl. tables

A single application of 0.1 mL KURG 101 per animal into the conjunctival sac of the right eye of three rabbits did not cause any changes at the observation time points 1, 24, 48 and 72 hours post application.

There were no systemic intolerance reactions.

               

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

Classification: not irritating

Executive summary:

In an eye irritation study according to OECD TG 405 KURG 101 was instilled into the conjunctival sac of one eye of 3 male rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. No irritation effects were seen at cornea, iris or conjunctivae during the observation period. No systemic intolerance reactions were observed. According to classification criteria KURG 101 is considered as "non-irritating to the eyes".