Registration Dossier

Administrative data

Description of key information

Skin irritation (WoE, similar to OECD 404): SCL: ≤50% (a.i.): not irritating; SCL >50% (a.i.): irritating (D-Glucopyranose, oligomeric, undecyl glycoside and RA from CAS 110615-47-9 and CAS 157707-87-4)
Eye irritation (similar to OECD 405): SCL: ≥1% and ≤10% (a.i.): irritating; SCL >10% (a.i.): corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
8 - 11 Dec 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The non-GLP study was performed equivalent to an appropriate OECD guideline. Only 10% active ingredient (a.i.) tested
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Journal Officiel de la Republique Francaise (1982)
Deviations:
yes
Remarks:
10% a.i. tested, reading time points 24 and 72 h only, limited study design information
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: distilled water
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 55% a.i. product diluted to 18.2%, (i.e. 10% a.i.)
Duration of treatment / exposure:
no data
Observation period:
Reading time points: 24 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 0.5 mL of the solution was laid down on a square gauze which was immediately applied on the skin of each rabbit.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: No scoring was performed after 48 h, therefore, the same irritation scores as after 24 hours were assumed
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: No scoring was performed after 48 h, therefore, the same irritation scores as after 24 hours were assumed
Irritant / corrosive response data:
Slight erythema formation (grade 1) was recorded in all animals 24 h after start of exposure. These effects were fully reversible in all animals within 72 hours. No edema formation was detected in any animal.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the experimental conditions performed equivalent or similar to OECD TG 404 the test material appeared to be not irritating to skin when applied as 18.2% (10% a.i.) formulation.

SCL (worst case assumption due to lack of data for neat substance):
Not irritating ≤10% (a.i.)
Skin Irrit. Cat. 2 >10% (a.i.)
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
prolonged exposure to the test substance (24 h); duration of observation period insufficient
Justification for type of information:
refer to category justification provided in IUCLID section 13
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
prolonged exposure to the test substance (24 h); duration of observation period insufficient
GLP compliance:
no
Species:
rabbit
Strain:
other: Japanese white rabbit
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sankyo Labo Service
- Age at study initiation: 16 weeks
- Weight at study initiation: 2.63-2.88 kg
- Housing: single
- Diet: RC4, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
other: intact skin: shaved with electronic clipper and razor; abraded skin: abraded by syringe (18G)
Vehicle:
other: phosphate buffered saline 1/15 M pH 7.2
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted (50% a.i.), 30% (w/v) (15% a.i.), 3% (w/v) (1.5% a.i.)
Duration of treatment / exposure:
24 h
Observation period:
48 h
reading time points: 3, 24 and 48 h
Number of animals:
6 animals/dose
Details on study design:
TEST SITE
- Area of exposure: 1×1 inch
- Type of wrap if used: cotton lint

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: testing stopped after 48 h; 72 h value anticipated for calculation purposes in order to avoid weighting of values
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: testing stopped after 48 h; 72 h value anticipated for calculation purposes in order to avoid weighting of values
Irritant / corrosive response data:
Erythema scores of 1 to 2 (score 2 in 2/6 animals) and edema values of 0 to 1 (score 1 in 5/6 animals) were observed on intact skin 3 hours after removal of the patch.

Table 1: Result of Alkyl polyglucoside Primary skin irritation test in rabbit (total table) (reaction rate of score ≥2)

Sample

Item of observation

Intact skin

Abraded skin

3*

24*

48*

3*

24*

48*

Undiluted

Erythema

2/6

1/6

0/6

4/6

1/6

1/6

Edema

0/6

0/6

0/6

2/6

0/6

0/6

30% diluted (15% a.i.)

Erythema

0/6

0/6

0/6

0/6

0/6

0/6

Edema

0/6

0/6

0/6

0/6

0/6

0/6

3% diluted (1.5% a.i.)

Erythema

0/6

0/6

0/6

0/6

0/6

0/6

Edema

0/6

0/6

0/6

0/6

0/6

0/6

Phosphate buffered saline

Erythema

0/6

0/6

0/6

0/6

0/6

0/6

Edema

0/6

0/6

0/6

0/6

0/6

0/6

* : time after patch removal

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the experimental conditions performed equivalent or similar to OECD TG 404 the test material appeared to be not irritating to skin when applied as 50% (a.i.) formulation.

SCL (worst case assumption due to lack of data for neat substance):
Not irritating ≤50% (a.i.)
Skin Irrit. Cat. 2 >50% (a.i.)
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
04 - 26 Jan 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Justification for type of information:
refer to category justification provided in IUCLID section 13
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive dressing
GLP compliance:
yes
Species:
rabbit
Strain:
other: Kleinrusse, Chbb: HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 2370 g (mean)
- Housing: Individually in rabbit batteries
- Diet: Zucht-/Haltungsdiät 20 ZH 5 (Nohrlin GmbH, Bad Salzuflen, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
21 days
Reading time points: 1, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: the treated skin was wrapped with a plastic foil and an Acrylastic tape.

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 4 animals
Time point:
other: mean after 24/48/72 h
Score:
2.9
Max. score:
4
Reversibility:
fully reversible within: 17 days
Remarks on result:
other: brownish discolouration was observed up to 3 days post-application; eschar formation was observed between Days 7 to 21
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 4 animals
Time point:
other: mean after 2/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
Moderate skin erythema and edema as well as eschar formation were observed after treatment. These reactions were fully reversible within 17 days.
Other effects:
No further local or systemic effects were observed.

Table 1. Results of skin irritation study

Observation time

Rabbit no.

1

2

3

4

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

1

0

1

0

1

0

1

0

24 h

3

2 B

3

2

2

1

3

2

48 h

3

2 B

3

2

3

2

3

2 B

72 h

3

3 B, A

3

3 B

3

2

3

2 B

B = brownish discolouration; A = cracked skin

Table 2. Calculation of mean scores

 

Rabbit no.

1

2

3

4

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Mean value

24 + 48 + 72 h*

3

2.33

3

2.33

2.67

1.67

3

2

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Under the experimental conditions performed equivalent or similar to OECD TG 404 the test material appeared to be irritating to skin when applied as 60% (a.i.) formulation.

SCL (worst case assumption due to lack of data for neat substance):
Skin Irrit. Cat. 2 ≤60% (a.i.)
Skin Corr. Cat. 1B >60% (a.i.)
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
refer to category justification provided in IUCLID section 13
Reason / purpose:
read-across source
Species:
rabbit
Strain:
other: Japanese white rabbit
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sankyo Labo Service
- Age at study initiation: 16 weeks
- Weight at study initiation: 2.63-2.88 kg
- Housing: single
- Diet: RC4, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): 17
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
other: intact skin: shaved with electronic clipper and razor; abraded skin: abraded by syringe (18G)
Vehicle:
other: phosphate buffered saline 1/15 M pH 7.2
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted (50% a.i.), 30% (w/v) (15% a.i.), 3% (w/v) (1.5% a.i.)
Duration of treatment / exposure:
24 h
Observation period:
48 h
reading time points: 3, 24 and 48 h
Number of animals:
6 animals/dose
Details on study design:
TEST SITE
- Area of exposure: 1×1 inch
- Type of wrap if used: cotton lint

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: testing stopped after 48 h; 72 h value anticipated for calculation purposes in order to avoid weighting of values
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: testing stopped after 48 h; 72 h value anticipated for calculation purposes in order to avoid weighting of values
Irritant / corrosive response data:
Erythema scores of 1 to 2 (score 2 in 2/6 animals) and edema values of 0 to 1 (score 1 in 5/6 animals) were observed on intact skin 3 hours after removal of the patch.

Table 1: Result of Alkyl polyglucoside Primary skin irritation test in rabbit (total table) (reaction rate of score ≥2

Sample

Item of observation

Intact skin

Abraded skin

3*

24*

48*

3*

24*

48*

Undiluted

Erythema

2/6

1/6

0/6

4/6

1/6

1/6

Edema

0/6

0/6

0/6

2/6

0/6

0/6

30% diluted (15% a.i.)

Erythema

0/6

0/6

0/6

0/6

0/6

0/6

Edema

0/6

0/6

0/6

0/6

0/6

0/6

3% diluted (1.5% a.i.)

Erythema

0/6

0/6

0/6

0/6

0/6

0/6

Edema

0/6

0/6

0/6

0/6

0/6

0/6

Phosphate buffered saline

Erythema

0/6

0/6

0/6

0/6

0/6

0/6

Edema

0/6

0/6

0/6

0/6

0/6

0/6

* : time after patch removal

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the experimental conditions performed equivalent or similar to OECD TG 404 the test material appeared to be not irritating to skin when applied as 50% (a.i.) formulation.

SCL (worst case assumption due to lack of data for neat substance):
Not irritating ≤50% (a.i.)
Skin Irrit. Cat. 2 >50% (a.i.)
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
refer to category justification provided in IUCLID section 13
Reason / purpose:
read-across source
Species:
rabbit
Strain:
other: Kleinrusse, Chbb: HM
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 2370 g (mean)
- Housing: Individually in rabbit batteries
- Diet: Zucht-/Haltungsdiät 20 ZH 5 (Nohrlin GmbH, Bad Salzuflen, Germany)
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
21 days
Reading time points: 1, 24, 48 and 72 h and 7, 10, 14, 17 and 21 days
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: the treated skin was wrapped with a plastic foil and an Acrylastic tape.

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 4 animals
Time point:
other: mean after 24/48/72 h
Score:
2.9
Max. score:
4
Reversibility:
fully reversible within: 17 days
Remarks on result:
other: brownish discolouration was observed up to 3 days post-application; eschar formation was observed between Days 7 to 21
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 4 animals
Time point:
other: mean after 2/48/72 h
Score:
2.1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritant / corrosive response data:
Moderate skin erythema and edema as well as eschar formation were observed after treatment. These reactions were fully reversible within 17 days.
Other effects:
No further local or systemic effects were observed.

Table 1. Results of skin irritation study

Observation time

Rabbit no.

1

2

3

4

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

1

0

1

0

1

0

1

0

24 h

3

2 B

3

2

2

1

3

2

48 h

3

2 B

3

2

3

2

3

2 B

72 h

3

3 B, A

3

3 B

3

2

3

2 B

B = brownish discolouration; A = cracked skin

Table 2. Calculation of mean scores

 

Rabbit no.

1

2

3

4

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Mean value

24 + 48 + 72 h*

3

2.33

3

2.33

2.67

1.67

3

2

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Under the experimental conditions performed equivalent or similar to OECD TG 404 the test material appeared to be irritating to skin when applied as 60% (a.i.) formulation.

SCL (worst case assumption due to lack of data for neat substance):
Skin Irrit. Cat. 2 ≤60% (a.i.)
Skin Corr. Cat. 1B >60% (a.i.)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
7 - 14 Dec 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The non-GLP study was performed equivalent to an appropriate OECD guideline. Only 10% (a.i.) was used in the study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Journal Officiel de la Republique Francaise (1992)
Deviations:
yes
Remarks:
Only 10% (a.i.) tested, limited study design information
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
other: distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: 55% product diluted to 18.2%, (i.e. 10% a.i.)
Duration of treatment / exposure:
Single application with washing after 30 sec (right eye)
Single application without washing (left eye)
Observation period (in vivo):
7 days
Reading time points: 1, 24, 48, 72 h and 4 and 7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the eyes was only performed on the right eye 30 sec after application of the test material. The left eye remained unwashed.
- Time after start of exposure: 30 sec

SCORING SYSTEM: Draize scoring system

Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Corneal opacity was noted in 2/3 animals (grade 11) 1 h after application of the test material.24 h after application of the test material corneal opacity was observed in 3/3 animals (grade 2). These effects were fully reversible within 4 days (1/3 animals) and 7 days (2/3 animals), respectively. Iris effects (grade 1) were recorded in 1/3 animals 24 h after application of the test material, but being fully reversible within 48 h. Conjunctivae effects (grade 1) were observed in 3/3 animals 1 h, 24, 48 and 72 h after application of the test material. These effects were fully reversible within 4 days (2/3 animals) and 7 days (1/3 animals), respectively. Chemosis was observed in 1/3 (grade 1) and 2/3 (grade 2) animals 1 h after application of the test material, but these effects were fully reversible within 72 h (2/3 animals with initially grade 2) and 4 days (1/3 animals with initially grade 1).
Other effects:
No mortalities occured during the study period.

Table 1: Individual scores for corneal opacity, iris, conjunctivae and chemosis effects

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

chemosis

1

 

 

 

 

1

1

1

0

0

24

1

1

0

2

48

1

1

0

2

72

1

1

0

2

average

1

1

0

2

2

 

 

 

 

1

1

2

0

1

24

1

1

0

2

48

1

1

0

2

72

1

0

0

2

average

1

0.67

0

2

3

 

 

 

 

1

1

2

0

1

24

1

1

1

2

48

1

1

0

2

72

1

0

0

2

average

1

0.67

0.33

2

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the experimental conditions performed equivalent or similar to OECD TG 405 the test material appeared to be irritating to eyes when applied as 10% (a.i.) formulation.

SCL (worst case assumption due to lack of data for neat substance):
Eye Irrit. Cat. 2 ≥1% (a.i.) and ≤10% (a.i.)
Eye Dam. Cat. 1 >10% (a.i.)
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In summary, one reliable study each addressing the skin and eye irritation/corrosive potential of D-Glucopyranose, oligomeric, undecyl glycoside is available. Moreover, read-across from the category members D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9) and D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides (CAS 157707-87-4) is included in the weight of evidence approach followed for assessment of skin irritation.

 

Skin irritation

A non-GLP skin irritation study with D-Glucopyranose, oligomeric, undecyl glycoside is available and was performed equivalent or similar to OECD TG 404 (BIOGIR, 1992a). In the study three rabbits of unknown strain were exposed to 0.5 mL of the test material (10% a.i.). Skin reactions were evaluated 24 and 72 hours post-application. No scoring was performed after 48 h, therefore, the same irritation scores as after 24 hours were assumed. Slight erythema formation (grade 1) was recorded in all animals 24 h after start of exposure. These effects were fully reversible in all animals within 72 hours (mean value over 24, 48 and 72 h: 0.67). No edema formation was detected in any animal. Based on the results of the study the test item should be considered as non-irritating when applied as 10% (a.i.) formulation.

 

A non-GLP skin irritation study with the category member D-Glucopyranose, oligomeric, C10-16-alkyl glycosides is available and was performed according to OECD TG 404 and in compliance with GLP (Henkel, 1988). In the study four Kleinrusse rabbits were exposed to 0.5 g of the test material (60% a.i.) for 4 hours under occlusive conditions. Skin reactions were evaluated 1, 24, 48 and 72 hours and 7, 10, 17 and 21 days post-application. Slight to moderate skin erythema (grade 1-3) and edema (grade 1-3) as well as eschar formation were observed in all animals after treatment. These reactions were fully reversible within 17 days. The mean values over 24, 48 and 72 hours were calculated to be 2.9 for erythema and 2.1 for edema. No further local or systemic effects were observed. Based on the results of the study the test item should be considered as irritating when applied as 60% (a.i.) formulation.

 

Another non-GLP study investigating the skin irritating potential of the category member D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides performed equivalent or similar to OECD TG 404 is available (Drug Safety Testing Center, 1988). Groups of six Japanese White rabbits per dose were exposed to the test substance undiluted (50% a.i.) or at concentrations of 30% (w/v) (15% a.i.) and 3% (w/v) (1.5% a.i.) in phosphate buffered saline (1/15 M pH 7.2), respectively for 24 h under occlusive conditions. Skin reactions were examined and the changes were graded according to the Draize scoring system 3, 24 and 48 hours post-application. The mean erythema score over 24, 48 and (predicted) 72 h and all animals was 0.7 for the undiluted test substance, and effects were not fully reversible within 48 h. However, this observation period was insufficient to assess the full reversibility of skin irritation. No erythema was noted after exposure to the test substance at 3 and 30% and no edema was seen at any concentration tested. The test item is considered as not irritating when applied as 50% (a.i.) formulation.

Eye irritation

A non-GLP eye irritation study performed equivalent or similar to OECD TG 405 with D-Glucopyranose, oligomeric, undecyl glycoside is available (BIOGIR, 1992b). For the assessment of the eye irritation properties 0.1 mL of the test substance (10% a.i.) was instilled in the eyes of three rabbits of unknown strain (right eye was washed after 30 sec, left eye remained unwashed). The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours and 4 and 7 days post-application. Only individual scores for conjunctivae, iris, corneal opacity and chemosis effects of the left eye (without rinsing) were evaluated.

 

Corneal opacity was noted in 2/3 animals (grade 11) 1 h after application of the test material.24 h after application of the test material corneal opacity was observed in 3/3 animals (grade 2). These effects were fully reversible within 4 days (1/3 animals) and 7 days (2/3 animals), respectively. Iris effects (grade 1) were recorded in 1/3 animals 24 h after application of the test material, but being fully reversible within 48 h. Conjunctivae effects (grade 1) were observed in 3/3 animals 1 h, 24, 48 and 72 h after application of the test material. These effects were fully reversible within 4 days (2/3 animals) and 7 days (1/3 animals), respectively. Chemosis was observed in 1/3 (grade 1) and 2/3 (grade 2) animals 1 h after application of the test material, but these effects were fully reversible within 72 h (2/3 animals with initially grade 2) and 4 days (1/3 animals with initially grade 1). Any effects observed had fully reversed at the end of the observation period. Based on the study results and according to EU classification criteria, the test substance is considered to be irritating to the eye when applied as 10% (a.i.) formulation, whereas classification as Eye Dam. 1 is assumed at higher concentrations (>10% a.i.).

 

Taken together and on the basis of the available data on irritation/corrosion of D-Glucopyranose, oligomeric, undecyl glycoside and the structurally related substances, D-Glucopyranose, oligomeric, undecyl glycoside has to be classified as Skin Irrit.2 (H315) at concentrations >50% (a.i.) and as Skin Corr. 1B (H314) >60% (a.i.) and as Eye Irrit. 2 (H319) with a SCL ≥1% and ≤10% (a.i.) and as Eye Dam. 1 (H318) with a SCL >10% according to Regulation (EC) No 1272/2008.

Justification for classification or non-classification

On the basis of the available data on skin irritation/corrosion of D-Glucopyranose, oligomeric, undecyl glycoside and the structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, 1.5, D-Glucopyranose, oligomeric, undecyl glycoside has to be classified as Skin Irrit. 2 (H315) with a SCL of >50% and ≤60% (a.i.) active ingredient and as Skin Corr. 1B (H314) with a SCL of >60% (a.i.) active ingredient according to Regulation (EC) No 1272/2008.

On the basis of the available data on eye irritation/corrosion of D-Glucopyranose, oligomeric, undecyl glycoside, the registered substance has to be classified as Eye Irrit. 2 (H319) with a SCL ≥1% and ≤10% (a.i.) active ingredient and as Eye Dam. 1 (H318) with a SCL >10% (a.i.) active ingredient according to Regulation (EC) No 1272/2008.