Distilled acetalization product between glucose and C12, C14, C18, C20 ,C22 alcohol

Endpoint summary

Description of key information

The substance is not irritating to the skin in animals and humans. It is slightly irritating to the eye in animals, without classification being required. For skin and eye irritation the conclusion is “Not classified - based on specific, valid data on the substance”. 
Considering these results in high-sensitivity assays, there is no reason to suspect any relevant respiratory irritation, especially as the granulometry of the substance (as the substance is in the form of pearls) leads to negligible exposure of terminal airways. For this route, the conclusion is “Not classified - based on weight-of-evidence analysis”.
Value used for CSA:
Skin irritation/corrosion: not irritating
Eye irritation: not irritating

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: new zealand albino rabbits
Origin: JEGARD Supplier (22120 Yffiniac, France)
Weight: superior to 1.8 kg the day before application of the substance
Number and sex: 3 males
Identification: each animal was identified by auricular ring and the corresponding number was written on a label put on its cage
Housing: animals were individually housed, in stainless steel cages
Air conditionned temperature: 20 +/- 3°C
Controlled relative humidity: 50 +/- 20 %
Artificial lighting: 12/12
Feeding: the complete diet was supplied under pelleted from ERGILAP Anco delivered by COFNA (37018 Tours , France)
Drinking: tap water distributed in polypropylene feeding-bottles with stainless steel teat.
Preparation of the animals and selection
Approximately 24 hours before application of the substance, fur was removed by close-clipping the dorsal area of the trunk of the animals.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Remarks:

substance impregnated with distilled water

Controls:

no

Amount / concentration applied:

0.5 g
The substance was impregnated with distilled water

Duration of treatment / exposure:

The rabbits kept the semioclusive patch for 4 hours.

Observation period:

Animals were examined for signs of erythema and oedema and the responses scored at 1 hour, and then at 24, 48, 72 hours after the patch removal.

Number of animals:

Three animals.

Details on study design:

A dose of 0.5 g of test substance was applied to a square of gauze patch of 2.5*2.5 cm (6 cm²) put on a Micropore tape of 5*5 cm (25 cm²).
The semi-occlusive dressing was applied to the clipped skin and held in place with an extensible bandage which surrounded the trunk of the animal and was fixed with Micropore.
the rabbits were put back into their cages for 4 hours and then the patch was removed. Residual test substance was removed using an absorbent paper moistered with distilled water or an appropriate solvent.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 48

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 48

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 48

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 48

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 48

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 48

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 72

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 72

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 72

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 72

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 72

Score:

ca. 0

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 72

Score:

ca. 0

Irritant / corrosive response data:

nothing to report

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Taking into account the criteria defined by the EEC 67/548 directive and its successive amendements,
COS 98091 (Montanov L) was not classified among the substances irritant to skin.

Executive summary:

The aim of the test was to assess qualitively and quantitatively the irritant or corrosive effect and the rate of onset after single application to skin, of the substance COS 98091 (Montanov L), in the rabbit.

The test substance was applied in a single dose (0.5 g) , under semi-occlusive patch, at 3 animals, one untreated skin area serving as control.

The degree of irritation was read and scored at specified intervals.

The duration of the test was suffcicient to evaluate fully the reversibility of the effects observed.

The albino rabbit is the mammalian species commonly used and recommended by the official authorities for the assessment of the cutaneous tolerance of chemical substances by this kind of method.

This test enabled to classify the test sunstance in one of the categories defined in the order of april 20, 1994 taken enforcement from the basic Directive 67/548/EEC and its successive amendements.

the methodology followed the OECD guideline n°404 of July 17, 1992, concerning the tests of chemical products, which defines dermal irritation as the production of reversible inflammatory changes in the skin, and the dermal corrosion as the production of irreversible tissue damage after application of the test substance.

Animals were examined for signs of erythema and oedema and the responses scored at 1 hour, and then at 24, 48, 72 hours after the patch removal.

For the clinical observations, there was nothing to report.

Taking into account the criteria defined by the EEC 67/548 directive and its successive amendements, COS 98091 (Montanov L) was not classified among the substances irritant to skin.

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:

from 1998-12-07 to 1998-12-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: this study has been conduced following an accepted OECD guideline and in compliance with the GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species: New Zealand albino rabbits
Origin: JEGARD Supplier (22120 Yffiniac, France)
Weight: superior to 1.8 kg, the day before application of the substance
Number and sex: 3 males
Acclimatization: for at least 5 days before the beginning of the test
Identification: each animal was identified by auricular ring and corresponding number was written on a label put on its cage
Housing: animals were individually housed, in stainless steel cages on floor grid
the cages were placed in limited-access premises, under air-conditioned temperature (20 +/- 3°C) and controlled relative humidity (HR= 50 +/- 20%).
Renewal of the air: 10 cycles per hour
The artificial lighting ensured a sequence of 12 hours light, 12 hours dark
Feeding: the complete diet was supplied under pelleted form ERGILAP Anco, delivered by COFNA (37018 Tours, France)
Drinking: tap water

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye is the control

Amount / concentration applied:

0.1 g of the test substance in the cunjunctival sac of one eye of each animal.

Duration of treatment / exposure:

After one hour of retention, animals were put back in their cages.

Observation period (in vivo):

cunjunctivae, iris and cornea were observed and the responses scored at 1h, 24h, 48h, 72h and 4 days after instillation by direct examination in white light.

Number of animals or in vitro replicates:

3 animals

Details on study design:

A single animal was test was employed. then two additional animals were tested.
0.1 g of the test substance in the cunjunctival sac of one eye of each animal.
After one hour of retention, animals were put back in their cages.
Cunjunctivae, iris and cornea were observed and the responses scored at 1h, 24h, 48h, 72h and 4 days after instillation by direct examination in white light.
In adition to the observations of cunjunctivae, iris and cornea, any other lesions were recorded and fully described.
After the recording observations at 24 hours, the eyes of all rabbits were further axamined after the instillation of fluorescein and rinsing 30 seconds later with 5 mL of 0.9% NaCl. Fluorescein was used for the following readings till no anomally was observed on the cornea.

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-72h

Score:

ca. 0

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-72h

Score:

ca. 0.7

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24-72h

Score:

ca. 1

Reversibility:

fully reversible

Irritation parameter:

other: redness

Basis:

animal #1

Time point:

other: 24-72h

Score:

ca. 1.3

Reversibility:

fully reversible

Irritation parameter:

other: redness

Basis:

animal #2

Time point:

other: 24-72h

Score:

ca. 1.3

Reversibility:

fully reversible

Irritation parameter:

other: redness

Basis:

animal #3

Time point:

other: 24-72h

Score:

ca. 1.7

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-72h

Score:

ca. 0

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-72h

Score:

ca. 0.3

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24-72h

Score:

ca. 0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-72h

Score:

ca. 0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-72h

Score:

ca. 0.3

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24-72h

Score:

ca. 0.3

Reversibility:

fully reversible

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

taking into account the criteria defined by the EEC 67/548 Directive and its successive amendments, the substance COS 98091 was not classified among the subsatnce irritant to eyes.

Executive summary:

The aim of the study was to assess qualitatively and quantitatively irrtancy or corrosion and the delay of appearence of the efects after single application of 0.1 g of test substance as such on eye in 3 rabbits.

The eye irritation reactions (redness and chemosis of cunjunctivae, iris and cornea lesions) were scored at 1 h, 24h, 48h, and 72h then 4 days after instillation.

The test substance was classified in accordance with the EEC 67/548 Directive and its successive amendements.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available