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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 May - 3 July 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexyl D-glucoside
EC Number:
259-217-6
EC Name:
Hexyl D-glucoside
Cas Number:
54549-24-5
Molecular formula:
C12H24O6
IUPAC Name:
(3R,4S,5S,6R)-2-hexoxy-6-(hydroxymethyl)oxane-3,4,5-triol
Details on test material:
- Name of test material (as cited in study report): trade name
- Physical state: amber viscous liquid
- Analytical purity: No data
- Lot/batch No.: P-8030
- Storage conditions : room temperature in the dark

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, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 302-398 g
- Housing: the animals were housed individually or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Guinea Pig FD1 Diet (Special Diets Services Limited, Witham, UK), ad libitum
- Water: tap water, ad libitum
- 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: From: 27 May 1998 To: 3 July 1998

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: undiluted or distilled water
Concentration / amount:
Induction: undiluted
Challenge: 75%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: undiluted or distilled water
Concentration / amount:
Induction: undiluted
Challenge: 75%
No. of animals per dose:
10 (controls), 20 (in test groups)
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. Since no skin reactions were observed at any concentration tested, the undiluted test substance (100% concentration) was used for topical induction.

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. Since no skin reactions were observed after application of 100 and 75% concentration of the test substance, these concentrations were selected for topical challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: undiluted test substance
- Control group: blank patch
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Days 0-14
- Concentrations: undiluted (100%)

Approximately 24 h after each induction application (Days 1, 8 and 15), the degree of erythema and oedema was quantified.

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (challenge)
- Day(s) of challenge: 28 (challenge)
- Exposure period: 6 hours
- Test groups: undiluted test substance and test substance in distilled water
- Control group: undiluted test substance and test substance in distilled water
- Site: right flank
- Concentrations: undiluted (100%) and 75% v/v
- Evaluation (hr after challenge): 24 and 48 h after dressing removal
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene (DNCB) and 2-mercaptobenzothiazole

Results and discussion

Positive control results:
The sensitivity and reliability of the experimental technique was assessed approximately every six months by use of positive control substances (2,4-dinitrochlorobenzene and 2-mercaptobenzothiazole ) which are known to have mild to moderate skin sensitisation properties.
The summarised data of positive controls during a period from September 1996 until July 1998 showed that DNCB and 2-mercaptobenzothiazole induced positive reactions in 100% and 35% of tested animals, thus meeting the reliability criteria for the Buehler test (≥ 15% positive responses).

In vivo (non-LLNA)

Resultsopen allclose all
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:
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:
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:
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:
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:
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:
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..
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.

Any other information on results incl. tables

One control group animal was found dead on Day 22. The absence of this animal was considered not to affect the purpose or integrity of the study. No effects on body weight were noted in all animals during the study period.

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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