Registration Dossier
Registration Dossier
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EC number: 234-634-6 | CAS number: 12018-10-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 6 June - 6 July 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-compliant, GLP-compliant, proprietary study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Three-induction Buehler test
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This study was conducted prior to introduction of the LLNA method as the default in-vivo method for REACH registration.
Test material
- Reference substance name:
- Chromium hydroxide sulphate
- EC Number:
- 235-595-8
- EC Name:
- Chromium hydroxide sulphate
- Cas Number:
- 12336-95-7
- Molecular formula:
- CrHO5S
- Reference substance name:
- Basic chromium (III) sulphate
- IUPAC Name:
- Basic chromium (III) sulphate
- Details on test material:
- Mixture of basic (III) chromium sulphate with sodium sulphate and water; batch 03.09. Sample 1
Described as a solid green powder
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 331-397 g
- Housing: groups of two or five
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 06/06/2006 To: 06/07/2006
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- A concentration of 80% was used for induction and challenge applications
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- A concentration of 80% was used for induction and challenge applications
- No. of animals per dose:
- Ten control animals; 20 test animals
- Details on study design:
- RANGE FINDING TESTS:
No signs of irritation were seen at concentrations of up to 80% (the highest tested) (6-hour occlusive application)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three
- Exposure period: six hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: once per week
- Duration: six hours
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: two weeks following the final induction
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: back and right flank
- Concentrations: 0% and 80%
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- Test and control animals were challenged with 80% test material (in physiological saline) and vehicle alone.
- Positive control substance(s):
- yes
- Remarks:
- alpha hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- Challenge with 20% positive control (in saline) resulted in dermal effects in 9/20 animals (45% response)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 80%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 80%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 80%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 80%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
Dermal reactions during the induction phase were limited to one animal following the second and third exposures (Grade 1 erythema, desquamation). Similar findings were not seen in this animal following challenge.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No evidence of sensitisation was seen under the conditions of this study.
- Executive summary:
The potential of the test material (a mixture of basic chromium sulphate, sodium sulphate and water) to induce delayed contact hypersensitivity (skin sensitisation) was investigated in a three-induction Buehler study using female Hartley guinea pigs. The concentrations of the test material used for induction and challenge applications were based on the results of a preliminary study. The results of an acceptable positive control study are also reported, confirming the sensitivity of the assay. Induction was performed on 20 test animals using 6 -hour semi-occlusive application of 0.5 ml test material (80% in physiological saline); a total of three applications were made over a three-week period. Ten control animals were similarly treatedm using vehicle. Two weeks following the final induction application, all test and control animals were challenged using a 6- hour semi-occlusive application of the test material (80%). Dermal reactions were assessed at 24 and 48 hours following patch removal. No dermal reactions were seen in test or control animals. No evidence of sensitisation was seen under the conditions of this study.
The substance tested in this study is considered to be a worse case based on its higher water solubility, dermal penetration and pH. The negative results of this study can therefore be confidently extrapolated to chromium (III) oxide.
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