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

Endpoint summary

Description of key information

The skin irritation potential was evaluated based on a Draize test (OECD 404) and a Patch test performed at 5% of the active substance. No skin irritation was significantly observed.
The eye irritation potential was assessed based on a Draize test (OECD 405). The substance was slightly irritating to the eyes but not classified according to the CLP criteria.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-07-31 to 2007-08-10

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test animals:
Three male 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 2.22 kg and 2.63 kg.

Housing:
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 47% and 65%
- 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.).

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the test item.

Number of animals:

3 animals

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Irritant / corrosive response data:

No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24, 48 and 72 hours).

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item LCE07050 according to the scales of interpretation dont' need to be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.

Executive summary:

The test item LCE07050 was applied, as supplied, at the dose of 0.5 g, under semi-occlusive dressing

during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established

from the O.E.C.D. guideline n° 404 dated April 24th, 2002 and the test method B.4 of the directive n°

2004/73/EC.

No cutaneous reactions (erythema and oedema) were observed whatever the examination time (1, 24,

48 and 72 hours).

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 classification, packaging and

labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548,

2001/59 and 99/45. No symbol and risk phrase are required.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-06-26 to 200-08-23

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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.).

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.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

based on mean calculations

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

Based on mean calculations

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

Based on mean calculations

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean calculations

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

based on mean calculations

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

Based on mean calculations

Time point:

24/48/72 h

Score:

ca. 0.7

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 8

Max. score:

8

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

24 h

Score:

ca. 2

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

48 h

Score:

ca. 0.7

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

Based on mean calculations

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean calculations

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

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

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 LCE07050 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 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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The substance was not classified as irritating to skin and eyes.