Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

guinea pig, Buehler Test, OECD 406, GLP, negative

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
17 July 1992
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
EPA 712-C-03-197, March 2003
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
study was performed before the LLNA was the standard test method
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratory Animal Breeders in 88353 Kisslegg, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: Specific-pathogen-free (SPF)-bred animals
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 331-397 g
- Housing: During the adaptation and study period the animals were conventionally kept in Noryl cages in groups of eight during the adaptation period and in groups of two or five per cage throughout the study period. The cages were exchanged for ones with clean bedding at least two times per week. Low-dust wood shavings were used as bedding. The wood shavings were spotchecked for contaminant levels. The analytical results provided no evidence for an effect on the study objective.
- Diet: ad libitum ("PROVIMI KLIBA 3420 - Maintenance Diet for Guinea Pigs" supplied by PROVOMI KLIBA AG)
- Water: ad libitum (tap water)
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): >=10
- Photoperiod (hrs dark / hrs light): 12/12
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
80%
Day(s)/duration:
day 1
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
80 %
Day(s)/duration:
day 8
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
80 %
Day(s)/duration:
day 15
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, semiocclusive
Vehicle:
physiological saline
Concentration / amount:
80%
Day(s)/duration:
day 29
No. of animals per dose:
10 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: 3
- Exposure period: 6 h
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: three times at intervals of seven days
- Duration: 0 - 15 d
- Concentrations: 80%


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 29
- Exposure period: 6 h
- Test groups: 20 animals
- Control group: 10 animals
- Site: back and right flank
- Concentrations: 80%
- Evaluation (hr after challenge): 30 and 54

OTHER:
The volume applied per animal was 0.5 ml. It was applied on a hypoallergic pad for induction and challenge exposure.
Challenge controls:
Control animals were challenged with vehicle (physiological saline) alone.
Positive control substance(s):
yes
Remarks:
alpha hexyl cinnamic aldehyde
Positive control results:
Challenge with 20% positive control (in saline) resulted in dermal effects in 9/20 animals (45% response)
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
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
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
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
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
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
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
20 %
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
not specified
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
20 %
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
not specified

Appearance and behaviour of the test item group animals were not different from the control group. After the first induction no skin effects in the animals of the test item group and the control group were observed. After the second and third induction 1 of 20 animals of the test item group showed skin effects. There were no skin effects in the animals of the control group. By the end of the study the mean body weight of the treatment group animals was in the same range than that of the control group.

Interpretation of results:
GHS criteria not met
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 GLP-compliant three-induction Buehler study according to OECD Test Guideline 406 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

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 GLP-compliant three-induction Buehler study according to OECD Test Guideline 406 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 (Vohr 2006).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of these studies, no classification is proposed according to Regulation (EC) No 1272/2008.