N-[(triethoxysilyl)methyl]cyclohexylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb 12 - March 29, 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

revised in 1997

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

454-780-6

EC Name:

-

Cas Number:

27445-54-1

Molecular formula:

Hill formula: C12H27NO2Si CAS formula: C12H27NO2Si

IUPAC Name:

Cyclohexyl-((diethoxy-methyl-silanyl)-methyl)-amine

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Test Animals
New Zealand White Rabbits Hsdlf:NZW. Source: Harlan Winkelmann GmbH, D-33178 Borchen.
Three female animals were used. Body weight at the commencement of the study: 4.1 kg; 3.9 kg; 3.7 kg
The animals were derived from a controlled full barrier maintained breeding system (SPF).
Animal Husbandry
Semi-barrier in an air conditioned room
Temperature: 18 ± 3°C
ReI. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: at least 10 x / hour
Free access to Altromin 2123 maintenance diet for rabbits, rich in crude fibre, totally pathogene free (TPF)
Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
Housed in ABS - plastic rabbit cages, floor 4200 cm2
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 females

Details on study design:

The test item was applied in a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
Eyes were not rinsed.
The eyes were examined for signs of irritation throughout the observation period. Eye irritation was scored and recorded according to the grades in the table below.

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: no effect observed

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effect observed

Results 3

Irritation parameter:

chemosis score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect observed

Results 4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: no effect observed

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

Animal No. 1 showed redness grade 2 and chemosis as well as discharge grade 1 of the conjunctivae 1 hour post-dose. 24 hours post-dose redness had decreased to grade 1, chemosis and discharge had disappeared. 48 hours postdose all symptoms had disappeared.
Animal No. 2 showed redness as well as chemosis grade 2 and discharge grade 1 of the conjunctivae 1 hour post-dose. 24 hours post-dose redness was unchanged (grade 2), chemosis had decreased to grade 1 and discharge had disappeared. 48 hours post-dose only redness of the conjunctivae grade 1 was still observed and 72 hours post-dose all symptoms had disappeared.
Animal No. 3 showed redness grade 2 and chemosis as well as discharge grade 1 of the conjunctivae 1 hour post-dose. 24 hours post-dose redness had decreased to grade 1, chemosis and discharge had disappeared. 48 hours postdose all symptoms had disappeared.
The test item produced no corrosion or irreversible effects in any of the animals. No comeallesions were found upon fluorescein examination at the final reading.

Other effects:

No other toxic effects were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item produced slight eye irritation below the criteria for classification and labelling.

Executive summary:

The test for acute eye irritation/corrosion according to OECD Guideline No. 405 was performed with the test item.

In this eye irritation study the test item was applied to the lower conjunctival sac of one eye of 3 female NZW - rabbits (HsdIf:NZW) at a dose of 0.1 mL per application site. The untreated other eye served as control.

Considering the reported data of this irritation study it can be stated that the test item produced slight irritation but no corrosive effects.