Registration Dossier

Diss Factsheets

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:
other: Guideline-compliant, GLP-compliant, proprietary study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Chemical structure
Reference substance name:
Chromium hydroxide sulphate
EC Number:
235-595-8
EC Name:
Chromium hydroxide sulphate
Cas Number:
12336-95-7
Molecular formula:
CrHO5S
IUPAC Name:
chromium hydroxide sulphate
Constituent 2
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

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:
80% was used for induction and challenge
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
80% was used for induction and challenge
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 (based on the results of this study)
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 treated, 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.

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