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Registration Dossier
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EC number: 420-920-1 | CAS number: 128446-35-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- 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 - 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.
- 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)
- 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.
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation:
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 producedbysensitization.
Duringthe initialinduction phase of thesensitization study,eachanimalreceivedthree 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 materialwas administered at a 0.2% (w/v)inpropylene glycol. Each vehicle control groupreceived singleadministrations 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 forthepositive control materialwas 70% (GradeIV)at48hours and 80%(Grade IV)at72 hours. The positive control material, DNCB,was consideredastrong sensitizer. This positive response demonstrated the susceptibility of the guinea pigs used in this study to dermal sensitization.
Thetestmaterial, Hydroxypropyl Beta Cyclodextrin, demonstrated no potential to produce dermal sensitizationwhenadministered to Hartleyguinea pigs.Thesensitization ratefor thetest material was 0% (Grade I). At challenge, Hydroxypropyl Beta Cyclodextrin produced dermal responses (low incidences of very faint erythema) which weresimilarin the test and vehicle controlgroupanimals. Thereforeit wasconcluded that thetest material was notasensitizerwhenadministered to Hartley guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
1st reading after 48h: test group with 100% dose level caused no reactions (0) on a total number of 20 animals/group.
2nd reading after 72h: test group with 100% dose level caused no reactions (0) on a total number of 20 animals/group.
1st reading after 48h: negative control with 100% dose level caused no reactions (0) on a total number of 10 animals/group.
2nd reading after 72h: negative control with 100% dose level caused no reactions (0) on a total number of 10 animals/group.
1st reading after 48h: positive control with 0,08% dose level caused reactions in 10 animals on a total number of 10 animals/group.
2nd reading after 72h: positive control with 0,08% dose level caused reactions in 10 animals on a total number of 10 animals/group.
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