acetalization product beween glucose and 12-hydroxystearyl alcohol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2007-06-26 to 2007-08-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conduced following an accepted OECD guideline and in compliance with the Good Laboratory Practice.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

acetalization product between glucose and C16/18(even numbered)-alcohol

IUPAC Name:

acetalization product between glucose and C16/18(even numbered)-alcohol

Details on test material:

- Name of test material (as cited in study report): LCE07050
- Physical state: solid, powder
- Analytical purity: 100%
- Composition of test material, percentage of components: 67762-27-0, 54549-27-8, 27836-65-3
- Lot/batch No.: T70615
- Expiration date of the lot/batch: 07 February 2009 (re-test)
- Storage condition of test material: at the room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three female albino New Zealand rabbits were supplied by the Elevage de Gérome (Quartier Labaste
– F40260 Linxe). They were kept during a minimal 5-day acclimatisation period. During the test, the
animals weighed between 2.27 kg and 2.77 kg.
Each animal was kept in an individual box installed in conventional air conditioned animal
husbanding; the environmental conditions were:
- temperature : between 19°C and 23°C
- relative humidity : between 43% and 72%
- lighting time: 12 hours daily
Drinking water (tap-water from public distribution system) and foodstuff were supplied freely.
Microbiological and chemical analyses of the water were carried out once every six months by the
Institut Européen de l'Environnement de Bordeaux (I.E.E.B.).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g of the test item was instilled into the conjunctival sac of the eye.

Duration of treatment / exposure:

One single adminitration of the product with no rinsing before ocular examinations.

Observation period (in vivo):

Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment

Number of animals or in vitro replicates:

3

Details on study design:

0.1 g of the test item was instilled into the conjunctival sac of one eye, the other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 h

Score:

ca. 0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24-72h

Score:

ca. 0

Max. score:

0

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72h

Score:

ca. 0

Max. score:

0

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 hours

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 hours

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24 hours

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 8

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

The ocular conjunctivae reactions observed during the study have been slight and totally reversible in the three animals: a slight redness, noted 1 hour after the test item instillation and totally reversible between D2 and D3, associated with a slight chemosis only noted 1 hour after the test item instillation.
- 1 hour after instillation: Total score = 24, average irritation index= 8.0
- 24 hours after instillation: Total score = 6, average irritation index= 2.0
- 48 hours after instillation: Total score = 2, average irritation index= 0.7
- 72 hours after instillation: Total score = 0, average irritation index= 0
Max OI = 8.0

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: Journal Officiel de la République Française dated July 10th 1992

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item
LCE07050 need not to be classified, according to the criteria for the classification, packaging and labelling
of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. No
symbol and risk phrase are required.

Executive summary:

The test item was instilled, into the eye of three New Zealand rabbits at the dose of 0.1 g.

The experimental protocol was established on the basis of the official method as defined in the

O.E.C.D. guideline n° 405 dated April 24th, 2002.

The ocular conjunctivae reactions observed during the study have been slight and totally reversible in

the three animals: a slight redness, noted 1 hour after the test item instillation and totally reversible

between D2 and D3, associated with a slight chemosis only noted 1 hour after the test item instillation.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the

test item need not to be classified according to the criteria for the classification,

packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548,

2001/59 and 99/45 and with regulation EC 1272/2008. No symbol and risk phrase are required.