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EC number: 500-394-9 | CAS number: 157707-87-4
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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
Test material
- Reference substance name:
- D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides
- EC Number:
- 500-394-9
- EC Name:
- D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides
- Cas Number:
- 157707-87-4
- Molecular formula:
- not applicable, UVCB substance
- IUPAC Name:
- not applicable, UVCB substance
- Details on test material:
- - Name of test material (as cited in study report): Alkyl polyglucoside
- Physical state: No data
- Analytical purity: 50%
- Lot/batch No.: AM-BS
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction: 0.6% (w/v) (0.3% AS)
Challenge: 6% (w/v) (3% AS), 2% (w/v) (1.0% AS), 1% (w/v) (0.5% AS)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction: 0.6% (w/v) (0.3% AS)
Challenge: 6% (w/v) (3% AS), 2% (w/v) (1.0% AS), 1% (w/v) (0.5% AS)
- 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: twice (Day 1 and 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 3% AS
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Induction: 0%; challenge: 3% AS. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 0.3% AS; challenge: 3% AS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 0.3% AS; challenge: 3% AS. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 3% AS
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Induction: 0%; challenge: 3% AS. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 0.3% AS; challenge: 3% AS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 0.3% AS; challenge: 3% AS. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 1% AS
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 1% AS. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 0.3% AS; challenge: 1% AS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 0.3% AS; challenge: 1% AS. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 1% AS
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 1% AS. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 0.3% AS; challenge: 1% AS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 0.3% AS; challenge: 1% AS. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 0.5% AS
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 0.5% AS. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 0.3% AS; challenge: 0.5% AS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 0.3% AS; challenge: 0.5% AS. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 0.5% AS
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 0.5% AS. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 0.3% AS; challenge: 0.5% AS
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 0.3% AS; challenge: 0.5% AS. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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