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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study performed in 1993, LLNA was not available by then.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
420-920-1
EC Name:
-
Cas Number:
128446-35-5
Molecular formula:
Hill formula: (C42H70-nO35)(C3H7O)n; n(mittel)=5,25
IUPAC Name:
2-Hydroxypropyl-.beta.-cyclodextrine ethers
Constituent 2
Reference substance name:
.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose
IUPAC Name:
.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): hydroxypropylated .beta.-cyclodextrin
- Physical state: white powder
- Storage condition of test material: stored in a secured area, at room temperature in the dark

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Inc., Scottdale, Pennsylvania
- Housing: individually in sainless steel cages
- Diet:ad libitum
- Water: ad libitum
- Acclimation period: minimum of 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 67-75 °
- Humidity (%): 40-70
- Air changes (per hr): 11 or more
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Intradermal: For the test material, negative control and the positive control, the volume injected into each site was 0.1 mL.
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
water
Concentration / amount:
Intradermal: For the test material, negative control and the positive control, the volume injected into each site was 0.1 mL.
No. of animals per dose:
32 males, 33 females
Details on study design:
RANGE FINDING TESTS: 3

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 1
- Control group: 3
- Site: scalpular regoin of the back
- Frequency of applications: one week's time
- Duration: 48h
- Concentrations: 100%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 3
- Test groups: 1
- Control group: 1
- Site: left side of the midline of the back
- Concentrations: 100%
- Evaluation (hr after challenge): approx. 48 and 72 hrs after challenge application
Positive control substance(s):
yes
Remarks:
dinitrochlorobenzene (DNCB)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st 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: 1st 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:
72
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: 72.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0,08%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0,08%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
0,08%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 0,08%. No with. + reactions: 10.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material, Hydroxypropyl Beta Cyclodextrin, demonstrated no potential to produce dermal sensitization when administered to Hartley guinea pigs. The sensitization rate for the test material was 0% (Grade 1). At challenge, Hydroxypropyl Beta Cyclodextrin produced dermal responses (low incidences of very faint erythema) which were similar in the test and vehicle control group animals.
Therefore it was concluded that the test material was not a sensitizer when administered to Hartley guinea pigs.
Executive summary:

The study, equivalent to OECD guideline 406, was conducted to determine the potential for the test material, Hydroxypropyl Beta Cyclodextrin, to produce dermal sensitization in the guinea pig with intradermal and topical exposure. Dinitrochlorobenzene(DNCB)was tested concurrently as a positive control material. The vehicles for the test and positive control materials also vere tested and served as controls.

During the induction phase of the study, materials were administered intradermally to sites on the scapular region of Hartley guinea pigs at the initiation (Day0) and topically on Day 7. Fourteen days following the last induction dose, the animals were challenged. Vehicle irritation control groups were used for the materials during the challenge phase to differentiate dermal reactions producedbyirritation from those produced by sensitization.

During the initial induction phase of the sensitization study,each animal received three pairs of injections intradermally to sites on the scapular region of the back.

During the second induction phase, the test material was administered topically at a 100% concentration to animals in the test material group. The positive control material was administered at a 0.2% (w/v)in propylene glycol. Each vehicle control group received single administrations of the appropriate vehicle at a 100% concentration. During the challenge phase, the animals in the test material and vehicle control groups (1 and 2) received single topical administrations of Hydroxypropyl Beta Cyclodextrin at a 100% concentration and the vehicle, deionized water. The animals in the positive control and the vehicle control groups received single topical administrations ofDNCBat a 0.08% (w/v) concentrationin propylene glycol andthevehicle, propylene glycol.

The positive control material, DNCB, did elicit dermal sensitization in the positive control group animals. The sensitizationrate for the positive control materialwas 70% (GradeIV) at 48 hours and 80% (Grade IV) at 72 hours. The positive control material, DNCB,was considered a strong sensitizer. This positive response demonstrated the susceptibility of the guinea pigs used in this study to dermal sensitization.

The testmaterial, Hydroxypropyl Beta Cyclodextrin, demonstrated no potential to produce dermal sensitization when administered to Hartley guinea pigs. The sensitization rate for thetest material was 0% (Grade I). At challenge, Hydroxypropyl Beta Cyclodextrin produced dermal responses (low incidences of very faint erythema) which were similarin the test and vehicle control group animals. Therefore it was concluded that the test material was not a sensitizer when administered to Hartley guinea pigs.