Registration Dossier

Administrative data

Description of key information

Skin sensitisation (WoE, similar to OECD 406), GPMT: not sensitising (D-Glucopyranose, oligomeric, undecyl glycoside and RA from CAS 110615-47-9 and CAS 157707-87-4)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The non-GLP study was performed equivalent to an appropriate OECD guideline. 0.5% (a.i.) was used for induction although this concentration did not cause irritation
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive controls, limited information on test animals, concentration used for epicutaneous induction did not induce irritation
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed in 1993 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods".
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: COB.LABO.LAP., Yffiniac, France
- Weight at study initiation: 301-412 g
- Housing: animals were housed individually in polypropylene cages (310x465x190)
- Diet: complete pelleted diet UAR 106 (Epinay sur Orge, France), ad libitum
- Acclimation period: at least 5 days
Route:
intradermal and epicutaneous
Vehicle:
other: distilled water
Concentration / amount:
Intradermal Induction: 0.5% (a.i.) (v/v) in distilled water
Topical Induction: 0.5% (a.i.) (v/v) in distilled water
Day(s)/duration:
0-9
Adequacy of induction:
other: maximal not irritating concentration used for intradermal and epicutaneous induction
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water
Concentration / amount:
Topical Challenge: 0.25% and 0.5% (a.i.) (v/v) in distilled water
Day(s)/duration:
20
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 (controls), 20 (in test groups)
Details on study design:
RANGE FINDING TESTS: Yes, treatment concentrations of the main study are based on these results.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
- Injection 1: a 1:1 mixture (v/v) FCA/water
- Injection 2: test substance 0.5% active substance
- Injection 3: test substance 0.5% active substance in a 1:1 mixture (v/v) FCA/water
- Epicutaneous: test substance (0.5% a.i.) in distilled water
- Control group:
Intradermal (3 pairs of injections):
- Injection 1: a 1:1 mixture (v/v) FCA/water
- Injection 2: distilled water
- Injection 3: 50% vehicle (v/v) in a 1:1 mixture (v/v) FCA/water
- Epicutaneous: vehicle
- Site: dorsal level (intradermal + epicutaneous)
- Frequency of applications: intradermal on Day 0 and epicutaneous on Day 7
- Duration: Days 0-9
- Concentrations: intradermal 0.5% active substance, epicutaneous 0.5% active substance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 20
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: dorso-lumbar region
- Concentrations: 0.25 and 0.5% active substance
- Evaluation (hr after challenge): 24 and 48 h after patch removal
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%, challenge: 0.25% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions and clinical signs were observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%; challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions and clinical signs were observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Induction: 0.5% (a.i.), challenge: 0.25% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reactions and clinical signs were observed
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
Induction: 0.5% (a.i.), challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reactions and clinical signs were observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%, challenge: 0.25% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions and clinical signs were observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%, challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No skin reactions and clinical signs were observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
Induction: 0.5% (a.i.), challenge: 0.25% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reactions and clinical signs were observed
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
Induction: 0.5% (a.i.), challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin reactions and clinical signs were observed

No mortalities occurred and no signs of systemic toxicity were observed during the study period. Neither erythema nor edema were recorded. The mean weight gain calculated for the treated animals during the test period is not significantly different from that of the control animals.

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In a GPMT conducted equivalent OECD 406 the test material was not sensitising to the skin.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
08 Mar - 08 Apr 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no positive controls were used to show the sensitivity and reliability of the test
Justification for type of information:
refer to category justification provided in IUCLID section 13
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive controls were used to show the sensitivity and reliability of the assay
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed in 1988 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods".
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna, Tuttlingen, Germany (main study) and Winkelmann, Germany (preliminary study)
- Weight at study initiation: main study: 308.6 (controls) and 310.0 g (test groups); preliminary study: 334.7 g (group A), 312.7 g (group B) and 322.7 g (group C)
- Housing: animals were housed in groups of 5 (preliminary study) or groups of 2-3 (main study) in Makrolon Type IV cages.
- Diet: Altromin-Haltungsdiät 3032 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
other: undiluted 1,2-propylene glycol (epicutaneous); 20% 1,2-propylene glycol (intradermal)
Concentration / amount:
intradermal: 0.1% (a.i.)
epicutaneous: 10% (a.i.)
Day(s)/duration:
0-10
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: undiluted 1,2-propylene glycol
Concentration / amount:
1.25 and 2.5% (a.i.)
Day(s)/duration:
22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 (controls), 20 (test groups), 15 (preliminary study)
Details on study design:
RANGE FINDING TESTS:
A. Group A (5 animals) - Intradermal induction
- Test concentrations: 0.1, 0.5, 1.0 and 2.0%
- Results: 0.1% of the test substance was chosen for the main study, since it caused significant skin irritation and no necrosis.

B. Group B (5 animals) - Epicutaneous induction
Test concentrations: 5 and 10%
-Results: 10% of the test substance provoked slight skin irritation and eschar formation and was chosen as concentration for the main assay.

C. Group C (5 animals) - Challenge
Challenge: 2.5 and 5%
- Results: 2.5% of the test substance was selected for the main study, since 5% caused slight irritations in 4/5 animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)

- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) 50% FCA in 0.9% NaCl solution
Injection 2: test substance in 20% 1,2-propylene glycol
Injection 3: test substance in a 1:1 mixture (v/v) FCA
Epicutaneous: test substance in 1,2-propylene glycol

- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) 50% FCA in 0.9% NaCl solution
Injection 2: 20% 1,2-propylene glycol
Injection 3: 20% 1,2-propylene glycol in a 1:1 mixture (v/v) FCA
Epicutaneous: 1,2-propylene glycol

- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: twice (Day 1 and Day 8)
- Duration: Days 0-10
- Concentrations: intradermal 0.1%, epicutaneous 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 h
- Test groups: test substance in 1,2-propylene glycol
- Control group: test substance in 1,2-propylene glycol
- Site: right flank (test substance)
- Concentrations: 1.25 and 2.5%
- Evaluation (hr after challenge): 24 and 48 h after patch removal
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 1.25% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 2.5% (a.i.)
No. with + reactions:
3
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.1% (a.i.); challenge: 1.25% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.1% (a.i.); challenge: 2.5% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 1.25% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 2.5% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.1% (a.i.); challenge: 1.25% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.1% (a.i.); challenge: 2.5% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In a GPMT conducted equivalent OECD 406 and under GLP conditions the test material was not sensitising to the skin.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
no positive controls to demonstrate the sensitivity and reliability of the assay. No pilot study for selection of appropriate concentrations for induction and challenge treatment performed.
Justification for type of information:
refer to category justification provided in IUCLID section 13
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no positive controls to demonstrate the sensitivity and reliability of the assay; no pilot study for selection of appropriate concentrations for induction and challenge treatment performed
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was performed in 1988 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods".
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association of Laboratory Animals
- Age at study initiation: 4 weeks
- Weight at study initiation: 268-317 g
- Housing: 5 animals per cage
- Diet: RC4, ad libitum
- Water: sterilized tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): 23
- Photoperiod (hrs dark / hrs light): 12/12

Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
intradermal: 0.3% (a.i.)
epicutaneous: 10% (a.i.)
Day(s)/duration:
0-9
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
0.5%, 1.0% and 3% (a.i.)
Day(s)/duration:
22
Adequacy of challenge:
not specified
No. of animals per dose:
10 (control group), 20 (in test groups)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)

- Test groups:
Intradermal (3 pairs of injections):
Injection 1: FCA
Injection 2: test substance
Injection 3: test substance in a 1:1 mixture with FCA
Epicutaneous: test substance

- Control group:
Intradermal (3 pairs of injections):
Injection 1: FCA
Injection 2: phosphate buffered saline
Injection 3: phosphate buffered saline in a 1:1 mixture (v/v) FCA/0.9% NaCl
Epicutaneous: phosphate buffered saline

- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: intradermal on Day 1 and epicutaneous on Day 7
- Duration: Days 0-8
- Concentrations: intradermal 0.6% (w/v) (0.3% AS), epicutaneous 20% (w/v) (10% AS)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: right flank (test substance) and left flank (vehicle)
- Concentrations: 6% (w/v) (3% AS), 2% (w/v) (1.0% AS), 1% (w/v) (0.5% AS)
- Evaluation (hr after challenge): 24 and 48 h
Challenge controls:
The control group is equivalent to a challenge control.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 1% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%; challenge: 3% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 1% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 3% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 1% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%; challenge: 3% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 1% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 3% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In a GPMT conducted equivalent OECD 406 the test material was not sensitising to the skin.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna, Tuttlingen, Germany (main study) and Winkelmann, Germany (preliminary study)
- Weight at study initiation: main study: 308.6 (controls) and 310.0 g (test groups); preliminary study: 334.7 g (group A), 312.7 g (group B) and 322.7 g (group C)
- Housing: animals were housed in groups of 5 (preliminary study) or groups of 2-3 (main study) in Makrolon Type IV cages.
- Diet: Altromin-Haltungsdiät 3032 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
other: undiluted 1,2-propylene glycol (epicutaneous); 20% 1,2-propylene glycol (intradermal)
Concentration / amount:
intradermal: 0.1% (a.i.)
epicutaneous: 10% (a.i.)
Day(s)/duration:
0-10
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: undiluted 1,2-propylene glycol
Concentration / amount:
1.25 and 2.5% (a.i.)
Day(s)/duration:
22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
20 (controls), 20 (test groups), 15 (preliminary study)
Details on study design:
RANGE FINDING TESTS:
A. Group A (5 animals) - Intradermal induction
- Test concentrations: 0.1, 0.5, 1.0 and 2.0%
- Results: 0.1% of the test substance was chosen for the main study, since it caused significant skin irritation and no necrosis.

B. Group B (5 animals) - Epicutaneous induction
Test concentrations: 5 and 10%
-Results: 10% of the test substance provoked slight skin irritation and eschar formation and was chosen as concentration for the main assay.

C. Group C (5 animals) - Challenge
Challenge: 2.5 and 5%
- Results: 2.5% of the test substance was selected for the main study, since 5% caused slight irritations in 4/5 animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)

- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) 50% FCA in 0.9% NaCl solution
Injection 2: test substance in 20% 1,2-propylene glycol
Injection 3: test substance in a 1:1 mixture (v/v) FCA
Epicutaneous: test substance in 1,2-propylene glycol

- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) 50% FCA in 0.9% NaCl solution
Injection 2: 20% 1,2-propylene glycol
Injection 3: 20% 1,2-propylene glycol in a 1:1 mixture (v/v) FCA
Epicutaneous: 1,2-propylene glycol

- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: twice (Day 1 and Day 8)
- Duration: Days 0-10
- Concentrations: intradermal 0.1%, epicutaneous 10%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 h
- Test groups: test substance in 1,2-propylene glycol
- Control group: test substance in 1,2-propylene glycol
- Site: right flank (test substance)
- Concentrations: 1.25 and 2.5%
- Evaluation (hr after challenge): 24 and 48 h after patch removal
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 1.25% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 2.5% (a.i.)
No. with + reactions:
3
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.1% (a.i.); challenge: 1.25% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.1% (a.i.); challenge: 2.5% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 1.25% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 2.5% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.1% (a.i.); challenge: 1.25% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.1% (a.i.); challenge: 2.5% (a.i.)
No. with + reactions:
1
Total no. in group:
20
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In a GPMT conducted equivalent OECD 406 and under GLP conditions the test material was not sensitising to the skin.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
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:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association of Laboratory Animals
- Age at study initiation: 4 weeks
- Weight at study initiation: 268-317 g
- Housing: 5 animals per cage
- Diet: RC4, ad libitum
- Water: sterilized tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): 23
- Photoperiod (hrs dark / hrs light): 12/12

Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
intradermal: 0.3% (a.i.)
epicutaneous: 10% (a.i.)
Day(s)/duration:
0-9
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
0.5%, 1.0% and 3% (a.i.)
Day(s)/duration:
22
Adequacy of challenge:
not specified
No. of animals per dose:
10 (control group), 20 (in test groups)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)

- Test groups:
Intradermal (3 pairs of injections):
Injection 1: FCA
Injection 2: test substance
Injection 3: test substance in a 1:1 mixture with FCA
Epicutaneous: test substance

- Control group:
Intradermal (3 pairs of injections):
Injection 1: FCA
Injection 2: phosphate buffered saline
Injection 3: phosphate buffered saline in a 1:1 mixture (v/v) FCA/0.9% NaCl
Epicutaneous: phosphate buffered saline

- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: intradermal on Day 1 and epicutaneous on Day 7
- Duration: Days 0-8
- Concentrations: intradermal 0.6% (w/v) (0.3% AS), epicutaneous 20% (w/v) (10% AS)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 22
- Exposure period: 24 h
- Test groups: test substance
- Control group: test substance
- Site: right flank (test substance) and left flank (vehicle)
- Concentrations: 6% (w/v) (3% AS), 2% (w/v) (1.0% AS), 1% (w/v) (0.5% AS)
- Evaluation (hr after challenge): 24 and 48 h
Challenge controls:
The control group is equivalent to a challenge control.
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 1% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
Induction: 0%; challenge: 3% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 1% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 3% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 1% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
Induction: 0%; challenge: 3% (a.i.)
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 0.5% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 1% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
induction: 0.3% (a.i.); challenge: 3% (a.i.)
No. with + reactions:
0
Total no. in group:
20
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In a GPMT conducted equivalent OECD 406 the test material was not sensitising to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
There are only limited data (RL2, non-GLP study) available on the skin sensitisation potential of D-Glucopyranose, oligomeric, undecyl glycoside. Therefore, in order to fulfil the standard information requirements set out in Annex VII, 8.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, 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 conducted following the weight of evidence approach.

 

Skin sensitisation

The skin sensitising properties of D-Glucopyranose, oligomeric, undecyl glycoside were tested in a non-GLP study performed equivalent or similar to OECD TG 406 using the Guinea pig maximization test (GPMT, EVIC-CEBA, 1993). The GPMT test was performed on 30 female Dunkin-Hartley guinea pigs. For the intradermal and epicutaneous inductions the test item concentration was 0.5% active ingredient (v/v in distilled water) whereas 0.25% and 0.5% (a.i.) (v/v in distilled water) formulations were selected for the challenge exposure. At the beginning of the induction exposure 20 test animals and 10 control animals were intradermally treated with 0.5% (a.i.) of the test substance and vehicle (Day 0), respectively, followed by a topical induction (0.5% a.i.) under occlusive conditions one week later. On Day 20 all animals were challenged for 24 h with the test substance at a concentration of 0.25% and 0.5% (a.i.). under occlusive conditions. Skin reactions of all animals were evaluated 48 and 72 hours after challenge administration. No mortalities occurred and no signs of systemic toxicity were observed during the study period. Neither erythema nor edema formation was recorded at any concentration in any animal. The mean weight gain calculated for the treated animals during the test period was not significantly different from that of the control animals. No information on periodically reliability checks of positive control animals is available. Thus, under the conditions of the test, the test substance revealed no skin sensitizing properties.

 

In another study, the skin sensitising properties of the category member D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9) were tested in a study performed equivalent or similar to OECD TG 406 and in compliance with GLP using the Guinea pig maximization test (GPMT, Henkel, 1988). The GPMT test was performed on 40 female Pirbright-Hartley guinea pigs. For the intradermal and epicutaneous inductions the initial test item concentration was 0.1% (a.i.) (v/v in 20% 1,2-propylene glycol) and 10% (a.i.) (v/v in 100% 1,2-propylene glycol) whereas a 1.25% and 2.5% (a.i.) (v/v in 100% 1,2-propylene glycol) formulation was selected for the epicutaneous induction and the challenge exposure. At the beginning of the induction exposure 20 test animals and 20 control animals were either intradermally treated with 0.1% (a.i.) of the test substance or vehicle (Day 0), followed by a topical induction of 10% (a.i.) of the test substance under occlusive conditions one week later. On Day 22 all animals were challenged with the test substance at a concentration of 1.25% and 2.5% (a.i.). Skin reactions of all animals were evaluated 48 and 72 hours after challenge administration. No mortalities occurred and no signs of systemic toxicity were observed during the study period. Slight erythema formation was recorded in 1/20 control animals 48 h after challenge administration (1.25% (a.i.)) which was still present after 72 hours. No erythema were recorded at animals of the test group following an induction exposure of 0.1% (a.i.) and challenge exposure of 1.25% (a.i.), neither 48 nor 72 hours after challenge exposure. Slight erythema formation was recorded in 3/20 control animals 48 h after challenge administration (2.5% (a.i.)) which was still present in 1/20 animals after 72 hours. Following an induction exposure of 0.1% (a.i.) of the test substance only 1/20 test group animals showed slight erythema formation 24 and 48 after challenge exposure (2.5% (a.i.)). No edema formation was recorded at any animal. No information on periodically reliability checks of positive control animals is available. Thus, under the conditions of the test, the test substance revealed no skin sensitizing properties.

 

In another study, the skin sensitising properties of the category member D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides (CAS 157707-87-4) were tested in a non-GLP study performed equivalent or similar to OECD TG 406 using the Guinea pig maximization test (GPMT, Drug Safety Testing Center, 1988). The GPMT test was performed on 30 female Hartley guinea pigs. For the intradermal and epicutaneous inductions the initial concentration was 0.3% (a.i.) (v/v in physiological saline) whereas 0.5%, 1% and 3% (a.i.) (v/v in physiological saline) formulations were selected for the epicutaneous induction and the challenge exposure. At the beginning of the induction exposure 20 test animals and 10 control animals were either intradermally treated with 0.5% (a.i.) test substance or vehicle (Day 0), followed by a topical induction of 0.5% (a.i.) of the test substance under occlusive conditions one week later. On Day 22 all animals were challenged with the test substance at concentrations of 0.5%, 1% and 3% (a.i.). Skin reactions of all animals were evaluated 48 and 72 hours after challenge administration. No mortalities occurred and no signs of systemic toxicity were observed during the study period. Neither erythema nor edema formation was recorded at any concentration in any animal. No information on periodically reliability checks of positive control animals is available and no pilot study for selection of appropriate concentrations for induction and challenge exposure was performed. In summary, under the conditions of the test, the test substance revealed no skin sensitizing properties. Thus, under the conditions of the test, the test substance revealed no skin sensitizing properties. 

 

Taken together, the above study results do not indicate any skin sensitising potential for either the D-Glucopyranose, oligomeric, undecyl glycoside or 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).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

The available data on skin sensitisation of D-Glucopyranose, oligomeric, undecyl glycoside and the structurally related substances according to Regulation (EC) No 1907/2006, Annex XI, 1.5 do not meet the criteria for classification according to Regulation (EC) No 1272/2008; therefore, D-Glucopyranose, oligomeric, undecyl glycoside does not meet the criteria for classification, either, and the data are thus conclusive but not sufficient for classification.