Isostearic acid, esters with methyl α-D-glucoside

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-08-25 to 2008-09-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2004

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

1998

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: JMAFF guidelines, 2000

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Isostearic acid, esters with methyl α-D-glucoside

EC Number:

700-680-5

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Isostearic acid, esters with methyl α-D-glucoside

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan France SARL, Gannat, France
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: in controlled environment, individual cages with perforated floors (Scanbur, Denmark, dimensions: 56x44x37.5 cm)
- Diet: pelleted diet for rabbits (K-H from SSNIFF Spezialdiäten GmbH, Soest, Germany), approx 100 g/day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water: ad libitum, tap water
- Acclimation period: at least 5 days before treatment


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): The test substance was instilled as delivered by the sponsor.

TREATMENT
Each animal was treated by instillation of 0.1 mL of the test substance, in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.

Duration of treatment / exposure:

no washing

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 1 week later, after considering the degree of eye irritation observed in the first animal.

TREATMENT
Each animal was treated by instillation of 0.1 mL of the test substance, in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

OBSERVATIONS:
Mortality: twice daily
Body weight: at least once daily
Irritation: The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance. The irritation
scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
According to OECD guideline 405

TOOL USED TO ASSESS SCORE:
Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp. In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission, Washington, D.C. 20207 was used for additional control purposes.

Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: # 1, 2, 3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: # 1, 2, 3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: # 1, 2, 3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

animal: # 1, 2, 3

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

- An irritation of the conjunctivae, which consisted of redness, was observed in one eye of each rabbit within the first hour. The irritation was fully reversible within 24 hours.
- No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.

Other effects:

- No other effects.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Area of Cornea involved	Fluor area (% positive, (24 h value)	Iris	Conjunctivae	Chemosis	Discharge
	Max. score: 4	Max score: 4	Max score: 2	Max. score: 2	Max. score: 3	Max. score 4	Max. score: 3
1h	0/0/0	0/0/0		0/0/0	1/1/1	0/0/0	0/0/0
24 h	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0	0/0/0
48 h	0/0/0	0/0/0		0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0		0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0			0/0/0	0/0/0	0/0/0	0/0/0
Reversibility*)	-			-	c.	-	-

*) Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

In this study the test substance is not irritating to the eye.

Executive summary:

In a primary eye irritation study according to OECD Guideline 405 0.1 ml of Isostearic acid, esters with methyl α-D-glucoside, was instilled as delivered by the sponsor into the conjunctival sac of one eye, each of three New Zealand White rabbits. The eyes were not washed. Animals were then observed for 72 hours. Irritation was scored according to OECD Guideline 405.

Instillation of the test substance resulted in irritation of the conjunctivae, which consisted of redness (score 1). The irritation completely resolved within 24 hours.

In this study, Isostearic acid, esters with methyl α-D-glucoside is not an eye irritant.