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Diss Factsheets

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
Study period:
1993-02-03 to 1993-03-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Guinea Pig Sensitization (Buehler)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A valid Buehler test conducted comparable to guideline with acceptable restrictions is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium carbonate
EC Number:
209-529-3
EC Name:
Potassium carbonate
Cas Number:
584-08-7
Molecular formula:
CH2O3.2K
IUPAC Name:
dipotassium carbonate

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, New Jersey
- Age at study initiation: no data in study summary
- Weight at study initiation: 357 - 446 g
- Housing: no data in study summary
- Diet (e.g. ad libitum): no data in study summary
- Water (e.g. ad libitum): no data in study summary
- Acclimation period: no data in study summary


ENVIRONMENTAL CONDITIONS
- no data in study summary

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
95 % for induction and challenge. To enhance skin contact, the substance was moistened with water (95% w/w).
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
95 % for induction and challenge. To enhance skin contact, the substance was moistened with water (95% w/w).
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
test group: 10 animals
negative control group: 5 animals
positive control group: 10 animals
negative control for positive control group: 5 animals
Details on study design:
After establishing the minimum irritating concentration (MIC) and the highest non-irritating concentration (HNIC) to be a 95 % w/w mixture in
distilled water, a 3 week induction period was initiated during which 10 young adult guinea pigs were treated with the test substance at its MIC
and 10 positive control animals were treated with Dinitrochlorobenzene (DNCS) at its MIC (0.08 % in 80 % aqueous ethanol). During the induction
period the animals were dosed once each week for three weeks. Fourteen days after the third induction a challenge dose was applied at the
respective test and positive control HNIC to a naive site on each group of guinea pigs. Approximately 24 and 48 hours later the animals were
scored for a sensitization response (erythema).
Challenge controls:
Two naive control groups of (5 animals for the test material and five for the positive control) were maintained under the same environmental
conditions and treated with the test or control substance at challenge only.
Positive control substance(s):
yes
Remarks:
Dinitrochlorobenzene (DNCB)

Results and discussion

Positive control results:
24 hours after challenge, 8 of 10 positive control sites exhibited signs of a sensitization response including faint to moderate erythema. These indications persisted at all sites through 48 hours.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
95 %
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
95 %
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
95 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
95 %
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.08 % in 80 % aqueous ethanol
No. with + reactions:
8
Total no. in group:
10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study, the test article "Biocide #5654, Potassium Carbonate" is not a dermal sensitizer.
Executive summary:

In a dermal sensitization study according to US EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Guinea Pig Sensitization (Buehler) with the test article "Biocide #5654, Potassium Carbonate" in water, young adult Hartley guinea pigs (10 test and 5 control animals) were tested using the method of Buehler. Positive control substance was Dinitrochlorobenzene (DNCB) with a sensitisation rate of 80 % (10 test and 5 control animals).

To enhance skin contact, the substance was moistened with water (95% w/w) for induction and challenge exposure. No irritation was noted at any of the test or negative control sites during the induction phase. After challenge exposure no skin reactions were observed in test or control animals at any observation time. Therefore, the sensitisation rate was 0 %.

In this study, the test article "Biocide #5654, Potassium Carbonate" is not a dermal sensitizer.