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Diss Factsheets

Administrative data

Description of key information

Reliable data from a Buehler sensitisation study according to US EPA/FIFRA Guideline in guinea pigs are available. There was no evidence for a skin sensitisation after challenge with 95 % of potassium carbonate. The sensitisation rate was 0 %.

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
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
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.
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
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
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)
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.
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
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.

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

As expected, there is no evidence for a skin sensitisation from a Buehler sensitisation study. The abiotic dissociation of potassium carbonate with tissue water results in the formation of potassium and carbonate ions. Potassium and carbonate ions are naturally occurring, effectively processed and regulated essential compounds in the body. K+or CO32- resulting from the ionisation (dissociation) of K2CO3 will not influence the natural K+or CO32- level in the body due to the natural regulation mechanisms.and for this reason it is very unlikely that potassium carbonate has an intrinsic sensitising activity. The absence of intrinsic toxic properties of potassium carbonate is generally taken for granted, which is proved by its long-standing safe use in foodstuffs and pharmaceuticals with no limitations other than current good manufacturing practice and its GRAS (generally recognized as safe) status in the USA.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No study available. However, based on the structure of potassium carbonate, no sensitising effects are expected. The abiotic dissociation of potassium carbonate with tissue water results in the formation of potassium and carbonate ions. Potassium and carbonate ions are naturally occurring, effectively processed and regulated essential compounds in the body and for this reason it is very unlikely that they could cause respiratory sensitisation. Absence of intrinsic toxic properties of potassium carbonate is generally taken for granted, which is proved by its long-standing safe use in foodstuffs and pharmaceuticals with no limitations other than current good manufacturing practice and its GRAS (generally recognized as safe) status in the USA.


Justification for classification or non-classification

Data from a Buehler study with guinea pigs indicate that potassium carbonate does not induce skin sensitisation. Further on, based on the structure of potassium carbonate, no sensitising effects are expected.

According to GHS Regulation (EC) No 1272/2008 potassium carbonate is not classified as “sensitising” and labelling is not required.