Bis(cyclohexyl)ammonium(2S)-2-{[(benzyloxy)carbonyl]amino}-3,3-dimethylbutanoate

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: Study conducted following the current relevant guideline and fully GLP compliant documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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:

-

EC Number:

478-250-9

EC Name:

-

Cas Number:

62965-37-1

Molecular formula:

C26H42N2O4

IUPAC Name:

(2S)-2-{[(benzyloxy)carbonyl]amino}-3,3-dimethylbutanoic acid; N-cyclohexylcyclohexanamine

Details on test material:

Batch number 25557

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation:17-36 weeks prior to treatment
- Weight at study initiation: 3.49-4.69 kg
- Housing: individually
- Diet: 125 g (Rabbit GD Diet Pellets) per day
- Water: ad libitum
- Acclimation period: 6 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

not specified

Controls:

other: The untreated eye was used as a comparison with the treated eye during assessment of ocular lesions

Amount / concentration applied:

55 mg

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48, 72 hours and 7 days after treatment

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 1-3

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: 1-3

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean of 24, 48 and 72 hours

Score:

0.3

Max. score:

3

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean of 24, 48 and 72 hours

Score:

0.3

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean of 24, 48 and 72 hours

Score:

0.7

Max. score:

3

Results 6

Irritation parameter:

chemosis score

Basis:

animal: 1-3

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Injection of the conjunctival blood vessels was apparent in all animals during the first 24 hours after instillation, persisting in one case to the
48 hour examination; very slight discharge was evident in two animals one hour after instillation. The treated eye of each animal was overtly normal
72 hours after instillation. Instillation of the test substance gave rise to a slight or practically no initial pain response

Other effects:

There was no sign of toxicity or ill health in any rabbit during the observation period

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Instillation of VRT-126017 DCHA gave rise to a “minimally irritating” response and the test substance did not require labelling with the risk phrase
R36, “Irritating to eyes”, in accordance with Commission Directive 2001/59/EC

Executive summary:

Three rabbits were each administered a single ocular dose of a volume of 0.1 ml of the test substance

weighing approximately 55 mg and observed for four days after instillation.

Injection of the conjunctival blood vessels was apparent in all animals during the first 24 hours after

instillation, persisting in one case to the 48 hour examination; very slight discharge was evident in two

animals one hour after instillation.

The treated eye of each animal was overtly normal 72 hours after instillation.

Instillation of the test substance gave rise to a slight or practically no initial pain response.

The means of scores for the ocular reactions at approximately 24, 48 and 72 hours after

administration, calculated separately for each animal, are summarised below:

Animal number               Corneal              Iridial                        Conjunctival

opacity               lesions        Redness                 Chemosis

4982                                 0.0                    0.0                0.3                            0.0

4986                                 0.0        0.0                0.3                            0.0

4987                      0.0        0.0                0.7                            0.0