Registration Dossier

Administrative data

Description of key information

Oral (OECD 423), rat (f): LD50 (cut-off) >5000 mg/kg bw (limit test)

Inhalation: Data waiving

Dermal (OECD 402), rat (m/f): LD50 >2000 mg/kg bw (limit test) (RA from CAS 110615 -47 -9 and CAS 68515 -73 -1)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 - 23 Jan 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
(2004)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Groupe interministeriel des produits chimiques, Paris, France
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: Sprague Dawley-SPF Caw
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Janvier Labs, Le Genest St. Isle, France
- Age at study initiation: eight weeks
- Weight at study initiation: 180 - 200 g
- Fasting period before study: from Day -1 to 4 h after the test administration
- Housing: in groups of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid; sawdust bedding.
- Diet: foodstuff, ad libitum (except during the fasting period)
- Water: tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 32 - 60
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.78 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (females)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed on Day 0 (just before administration) and on Days 2, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423 may be considered higher than 5000 mg/kg bw.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study and was similar between treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

The test material was investigated for acute oral toxicity according to the OECD TG 423, and in compliance with GLP. The test material (57.2 a.i.) was administered once via oral gavage to 6 female Sprague-Dawley rats at a dose of 2000 mg/kg bw. No mortality occurred and no signs of systemic toxicity were observed throughout the study period. Based on these findings, classification for acute oral toxicity according to Regulation (EC) No 1272/2008 is not warranted.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only short summary available
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only limited information on test material, animals and study design available, results reported only
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
other: no data
Vehicle:
not specified
Doses:
>2000 mg/kg bw
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Clinical signs:
No perceptible damages could be detected on the animals after a 14-day observation period.
Interpretation of results:
study cannot be used for classification
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 - 20 Dec 1989
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:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm, USA
- Weight at study initiation: 2870-2915 g (males), 2746-3057 g (females)
- Housing: individually in suspension cages with wire mesh floors
- Diet: PURINA Laboratory Rabbit Chow, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: the test substance was held in contact with the skin using a porous gauze dressing secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was removed with a moistened towel
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000mg/kg bw: 4.9-5.1 mL (males) and 4.8- 5.3 mL (females)
- Dose factor: 1.74 mL/kg


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for signs of toxicity and behavioural changes. Individual body weights were determined prior to treatment, on Day 7 and prior to necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
For body weights, mean values and standard deviations were calculated.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Partly hunched posture and slight depression occurred during the observation period.
Body weight:
No treatment-related changes.
Gross pathology:
No treatment-related changes.
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In conclusion, under the conditions chosen for this acute dermal toxicity study conducted according to OECD 402 at the limit concentration of 2000 mg/kg bw no severe clinical signs of toxicity or mortalities were observed. Therefore, the test substance does not need to be classified according to Regulation (EC) No 1272/2008.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
10 - 25 Feb 1987
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:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm
- Weight at study initiation: 2536-2979 g (males), 2528-2847 g (females)
- Housing: individually in wire mesh suspension cages
- Diet: Purina Laboratory Rabbit Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: the test material was introduced into the sleeve of a rubber dental dam, which was wrapped around the trunk and secured with staples. An outer layer of gauze was placed on the trunk and fixed with tapes.


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for gross signs of systemic toxicity once on the day of treatment and then twice during the 14-day observation period. Body weights were determined on the day of treatment (Day 0), and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal irritation, histopathology of unscheduled death
Statistics:
Mean values and standard deviations of body weights were calculated.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female died during the observation period (on Day 13).
Clinical signs:
Clinical changes associated with the test material were as follows:
1. Faecal stains
2. Yellow area throughout the site
3. Emaciated (2 animals)
4. Nasal discharge (3 animals)
5. Lacrimation (1 animal)
Body weight:
One male of 9 surviving animals lost weight (488 g).
Gross pathology:
A gross necropsy performed on the animal which died revealed the following:
1. Faecal stains
2. Discharge from the nose and mouth
3. Lungs appeared reddened
4. Spleen appeared darkened
5. Stomach appeared white
6. Liver covered with an excessive amount of white spots

In 5 of 9 surviving animals, a spotty area of haemorrhage was observed on the lungs at necropsy.
Other findings:
- Histopathology: microscopic examination of the animal which died on Day 13 confirmed the Tyzzer's disease as cause of death.
- Other observations: the most frequently observed irritative effects were as follows:
1. mild to marked erythema
2. mild to moderate edema
3. mild to moderate atony
4. mild to moderate desquamation
5. mild coriaceousness
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In conclusion, under the conditions chosen for this acute dermal toxicity study conducted according to OECD 402 at the limit concentration of 2000 mg/kg bw no severe clinical signs of toxicity occurred. Only one female animals died throughout the study period (day 13). Therefore, the test substance does not need to be classified according to Regulation (EC) No 1272/2008.
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
refer to category justification provided in IUCLID section 13
Reason / purpose:
read-across source
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm, USA
- Weight at study initiation: 2870-2915 g (males), 2746-3057 g (females)
- Housing: individually in suspension cages with wire mesh floors
- Diet: PURINA Laboratory Rabbit Chow, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: the test substance was held in contact with the skin using a porous gauze dressing secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was removed with a moistened towel
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000mg/kg bw: 4.9-5.1 mL (males) and 4.8- 5.3 mL (females)
- Dose factor: 1.74 mL/kg


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for signs of toxicity and behavioural changes. Individual body weights were determined prior to treatment, on Day 7 and prior to necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
For body weights, mean values and standard deviations were calculated.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Partly hunched posture and slight depression occurred during the observation period.
Body weight:
No treatment-related changes.
Gross pathology:
No treatment-related changes.
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In conclusion, under the conditions chosen for this acute dermal toxicity study conducted according to OECD 402 at the limit concentration of 2000 mg/kg bw no severe clinical signs of toxicity or mortalities were observed. Therefore, the test substance does not need to be classified according to Regulation (EC) No 1272/2008.
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
refer to category justification provided in IUCLID section 13
Reason / purpose:
read-across source
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm
- Weight at study initiation: 2536-2979 g (males), 2528-2847 g (females)
- Housing: individually in wire mesh suspension cages
- Diet: Purina Laboratory Rabbit Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: the test material was introduced into the sleeve of a rubber dental dam, which was wrapped around the trunk and secured with staples. An outer layer of gauze was placed on the trunk and fixed with tapes.


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for gross signs of systemic toxicity once on the day of treatment and then twice during the 14-day observation period. Body weights were determined on the day of treatment (Day 0), and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal irritation, histopathology of unscheduled death
Statistics:
Mean values and standard deviations of body weights were calculated.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female died during the observation period (on Day 13).
Clinical signs:
Clinical changes associated with the test material were as follows:
1. Faecal stains
2. Yellow area throughout the site
3. Emaciated (2 animals)
4. Nasal discharge (3 animals)
5. Lacrimation (1 animal)

Body weight:
One male of 9 surviving animals lost weight (488 g).
Gross pathology:
A gross necropsy performed on the animal which died revealed the following:
1. Faecal stains
2. Discharge from the nose and mouth
3. Lungs appeared reddened
4. Spleen appeared darkened
5. Stomach appeared white
6. Liver covered with an excessive amount of white spots

In 5 of 9 surviving animals, a spotty area of haemorrhage was observed on the lungs at necropsy.
Other findings:
- Histopathology: microscopic examination of the animal which died on Day 13 confirmed the Tyzzer's disease as cause of death.
- Other observations: the most frequently observed irritative effects were as follows:
1. mild to marked erythema
2. mild to moderate edema
3. mild to moderate atony
4. mild to moderate desquamation
5. mild coriaceousness
Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In conclusion, under the conditions chosen for this acute dermal toxicity study conducted according to OECD 402 at the limit concentration of 2000 mg/kg bw no severe clinical signs of toxicity occurred. Only one female animals died throughout the study period (day 13). Therefore, the test substance does not need to be classified according to Regulation (EC) No 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate, reliable (Klimisch score 2 due to read-across) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Additional information

There are no data available on the acute dermal toxicity of D-Glucopyranose, oligomeric, undecyl glycoside. In order to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances is conducted following a category concept.

A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 7.1 and 13).

 

Acute toxicitx: Oral

In this key acute oral toxicity study following the acute toxic class method (OECD TG 423, GLP) six female fasted Sprague Dawley rats were administered a single dose of 2000 mg/kg bw of the test substance D-Glucopyranose, oligomeric, undecyl glycoside whereas another six females (control animals) received the vehicle alone (distilled water) in a stepwise procedure (three rats per step) via oral gavage (Phycher Bio Development, 2008). No mortality and no signs of systemic toxicity were observed up to the end of the 14-day observation period. Body weight gain was normal and comparable between treated and control animals throughout the study period. Gross pathology revealed no treatment-related abnormalities in the animals. A thinning of the forestomach was noted in 2/6 animals at necropsy which was considered not to be a major sign of systemic toxicity. The acute oral LD50 value for females was considered to be greater than 2000 mg/kg bw. Moreover, in accordance with OECD TG 423, the oral LD50 cut-off of the test substance may be considered to be >5000 mg/kg bw.

 

Beside the key study a non-reliable (RL4) acute oral toxicity study (Hygiene Institut des Ruhrgebiets, 1999) with D-Glucopyranose, oligomeric, undecyl glycoside was performed according to OECD TG 401 in rats dosed with >2000 mg/kg bw of the test material. Only very limited information on study design, animal number, test material, analytical purity and environmental conditions during the treatment period is available. A LD50 value of >2000 mg/kg bw was derived for rats.

 

Acute toxicity: Inhalation

No information on acute inhalation toxicity is available for either the target or the read across substances. As D-Glucopyranose, oligomeric, undecyl glycoside has a low vapour pressure and is marketed in aqueous formulation exposure to vapours or dusts is not to be expected. In addition, aerosol application is excluded by the registrant. Furthermore, reliable data from studies for acute toxicity via the oral route with the substance itself and for acute toxicity via the dermal route performed with structurally related substances according to Regulation (EC) No. 1907/2006, Annex XI, article 1.5 are available. 

 

Acute toxicity: Dermal

No data on acute dermal toxicity is available with D-Glucopyranose, oligomeric, undecyl glycoside. Therefore, read across from the category members D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1) and D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9) was applied.

 

A reliable key acute dermal toxicity study performed equivalent or similar to OECD TG 402 and in compliance with GLP with the category member D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9) is available (Hill Top Biolabs, 1989). In this limit test five New Zealand White rabbits of each sex were exposed to a single dose of 2000 mg/kg bw of the test substance for 24 h via semi-occlusive dressing and observed for 14 days post-application. The acute dermal LD50 value was calculated to be greater than 2000 mg/kg bw. No severe clinical signs of toxicity were reported and no mortalities occurred during the observation period. Partly hunched posture and slight depression occurred during the observation period. Animals showed expected gains in bodyweight over the study period and no treatment-related changes were observed at necropsy at the end of the 14-day observation period.

 

A reliable supporting acute dermal toxicity study performed equivalent or similar to OECD TG 402 and in compliance with GLP with the category member D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1) is available (Hill Top Research, 1987). In this limit test five New Zealand White rabbits of each sex were exposed to a single dose of 2000 mg/kg bw of the test substance for 24 h via semi-occlusive dressing and observed for 14 days post-application. The acute dermal LD50 value was calculated to be greater than 2000 mg/kg bw. One animal died during the 14-day observation period (Day 13). Microscopically examination revealed the Tyzzer´s disease as cause of death. Test substance-related clinical changes of emaciation (2/5), nasal discharge (3/5), faecal stains (5/5), yellow area throughout the site of application (5/5) and lacrimation (1/5) were recorded in the animals. Irritative effects on the skin in the form of moderate to marked erythema, mild to moderate edema, atonia, desquamation, and mild coriaceousness were most frequently observed within the animals. Body weight gain was recorded in 8/9 animals whereas 1/9 animals lost weight during the 14-day observation period. Gross pathology revealed a spotty area of haemorrhage in the lungs in 5/9 animals at the end of the observation period.

 

Based on the above study results with D-Glucopyranose, oligomeric, undecyl glycoside and the category members D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1) and D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9) and according to EU classification criteria, the test substance D-Glucopyranose, oligomeric, undecyl glycoside is not to be classified.

Justification for classification or non-classification

The available data on the acute toxicity 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.