Registration Dossier
Registration Dossier
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EC number: 500-220-1 | CAS number: 68515-73-1
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 27 May 1998 - 3 July 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study. Reliability changed from "1" to "2" according to ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)."
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Hexyl D-glucoside
- EC Number:
- 259-217-6
- EC Name:
- Hexyl D-glucoside
- Cas Number:
- 54549-24-5
- IUPAC Name:
- hexyl hexopyranoside
- Details on test material:
- - Name of test material (as cited in study report): trade name
- Physical state: Amber viscous liquid
- Analytical purity: not stated in the report
- Lot/batch No.: P-8030
- Storage conditions : room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 302-398g
- Housing: The animals were housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Free access to food (Guinea Pig FD1 Diet, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
- Water: Free access to mains tap water was allowed.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 46-76
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: between 27 May 1998 and 3 July 1998
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: undiluted or water
- Concentration / amount:
- Induction: undiluted
Challenge: simultaneously undiluted (left flank) and 75% in distilled water (right flank)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: undiluted or water
- Concentration / amount:
- Induction: undiluted
Challenge: simultaneously undiluted (left flank) and 75% in distilled water (right flank)
- No. of animals per dose:
- 20 test animals and 10 control animals
- Details on study design:
- RANGE FINDING TESTS:
Selection of Concentration for Topical Induction:
Two previously untreated guinea pigs were treated with undiluted test material and three concentrations of the test material in distilled water (75%, 50%, and 25% v/v). Applications were made to the clipped flanks under occlusive dressings for an exposure period of 6 hours. The degree of erythema and oedema was evaluated 24 and 48 hours after dressing removal. The highest concentration of the test material producing only mild dermal irritation was selected for the topical induction stage of the main study.
Selection of Concentration for Topical Challenge
Two guinea pigs were treated with undiluted test material and one concentration of the test material in distilled water (75% v/v). These animals had been treated identically to the control animals of the main study on Days 0, 7 and 14. Applications were made to the clipped flanks under occlusive dressings for an exposure period of six hours. The degree of erythema and oedema was evaluated 24 and 48 hours after dressing removal. The highest concentration of the test material which produced no evidence of dermal irritation, and one lower concentration were selected for the topical challenge stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank, 20mm x 20 mm patch
- Frequency of applications: day 0, 7 and 14.
- Concentrations: undiluted
Approximately 24 hours after each induction application (Days 1, 8 and 15) the degree of erythema and oedema was quantified.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank, 20 mm x 20 mm
- Concentrations: undiluted, 75% v/v
- Evaluation (hr after challenge): Approximately 24 and 48 hours after dressing removal, the degree of erythema and oedema was quantified - Challenge controls:
- similar as the test group
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- 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: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- One animal was found dead on Day 22.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: One animal was found dead on Day 22..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- 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: 75%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- One animal was found dead on Day 22.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: One animal was found dead on Day 22..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- One animal was found dead on Day 22.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: One animal was found dead on Day 22..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Clinical observations:
- One animal was found dead on Day 22.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: One animal was found dead on Day 22..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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