D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 January 2014 to 17 January 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Adequate in vivo testing carried out for US regulation, hence no in vitro study is provided.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

EC Number:

941-129-0

Cas Number:

1407974-32-6

Molecular formula:

C15H28O7 - C25H46O7

IUPAC Name:

D-Glucopyranoside, methyl, mixed decanoates and octanoates and oleates

Test material form:

liquid: viscous

Details on test material:

- Substance type: UVCB
- Physical state: viscous yellowish liquid
- Analytical purity: 100% as UVCB
- Storage condition of test material: room temperature in the dark

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: 11 weeks
- Weight at study initiation: 1791 - 1967g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Water (e.g. ad libitum): Community tap-water from Itingen ad libitumin water bottles.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 ± 3 °C
- Humidity (%):30 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light):12 hours light and 12 hours darkness.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml/animal

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: The eye reactions were assessed according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5

TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp. To assess the presence ofcorneal damage, instillation of a 0.5% fluorescein solution was performed directly onto the cornea of both eyesand assessment was performed with a hand slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes 1 hour after treatment, such as reddening of the conjunctivae and sclerae, ocular discharge and slight iris light reflex. These effects were reversible and were no longer evident 24 hours after treatment. No abnormal findings were observed in the cornea of any animals at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinicalsigns were observed. Thus, the test item did not induce significant or irreversibledamage to the rabbit eye.
The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00 for reddening and 0.00 for chemosis for all animals, respectively.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item did not cause any damage to the rabbit eye. The individual mean scores for corneal opacity and iris light reflexwere 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00 for reddening and 0.00 for chemosis for all animals. Based on these results, the test item is considered to be “not irritating” to rabbit eye.

Executive summary:

Introduction

The primary eye irritation potential of the test item was investigated according to OECD test guideline no. 405, commission regulation 440/2008/EC, Japanese MAFF (2000) and EPA OPPTS 870.2400 (1998).

Method

The test item was applied by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation.

Results

The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes 1 hour after treatment, such as reddening of the conjunctivae and sclerae, ocular discharge and slight iris light reflex. These effects were reversible and were no longer evident 24 hours after treatment. No abnormal findings were observed in the cornea of any animals at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. The mean score was calculated separately for each animal across three scoring times (24, 48 and 72 hours after instillation) for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00 for reddening and 0.00 for chemosis for all animals, respectively. Based on these results, the test item is considered to be “not irritating” to rabbit eye.