Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation/corrosion:
- not a class 8 skin corrosive (acetic acid, 28% solution, in vivo, rabbit, IMGD/IATA Skin test for corrosivity)
- slightly irritating (Manganese Carbonate, in vivo, human, no guideline available)
- not irritating (commercial formulation of Potassium acetate, in vivo, rabbit, OECD 404)
Eye irritation:
- slightly irritating (Manganese carbonate, in vivo, human, no guideline available)
- not irritating (Potassium acetate, in vivo, rabbit, OECD 405)
- not irritating (Sodium acetate, 0.1 M aqueous solution, in vivo, rabbit, no guideline followed)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data derived from IUCLID 4 dataset of Potassium acetate, which can be freely downloaded from the EINECS search page (http://esis.jrc.ec.europa.eu/). Only basic data given, no further information can be retrieved.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no data
Duration of treatment / exposure:
no data
Observation period:
no data
Number of animals:
no data
Details on study design:
no data
Remarks on result:
other: No details on "Irritation parameter", "Time point" and "Score"; however, the available information is nevertheless considered to be sufficient to cover this endpoint.
Irritant / corrosive response data:
not irritating
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
It was concluded that Potassium acetate is not irritating. Although the reliability of the study cannot be assessed due to lacking data, the results are in congruence with a scientifically expected outcome. Potassium acetate does not need to be classified as skin irritant, and since it serves as a read-across substance for Manganese (II) acetate, the latter does not need to be classified, too.
Executive summary:

In a OECD 404 guideline study, a commercial formulation of potassium acetate was tested in rabbits for its skin irritating potency. Potassium acetate was not irritating to the rabbit skin, and since it serves as a read-across substance for Manganese (II) acetate, the latter does not need to be classified as skin irritant, too.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data derived from IUCLID 4 dataset of Potassium acetate, which can be freely downloaded from the EINECS search page (http://esis.jrc.ec.europa.eu/). Only basic data given, no further information can be retrieved.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
other: vehicle used, probably water
Controls:
not specified
Amount / concentration applied:
no data
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
no data
Details on study design:
no data
Irritation parameter:
other: individual mean score
Basis:
other: mean score of each animal
Time point:
other: no data
Score:
< 2.5
Reversibility:
fully reversible
Remarks:
Redness and swelling were transient.
Remarks on result:
other: Although described as slightly irritating in the report, the criteria for classification as R36 (i.e. H319) 'irritating to eyes' are not met by the results of this test.
Irritant / corrosive response data:
Result: slightly irritating
EC classification: not irritating
Redness and swelling were transient and individual mean scores were less than 2.5. Although described as slightly irritating in the report, the criteria for classification as R36 (i.e. H319) 'irritating to eyes' are not met by the results of this test.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The outcome of the test was that Potassium acetate is slightly irritating to the eye. But the authors concluded that, since the individual mean scores were less than 2.5, the criteria for classification as R36 (i.e. H319) 'irritating to eyes' are not met by the results of this test. Although the reliability of the study cannot be assessed due to lacking data, the results are in congruence with a scientifically expected outcome. Hence, the effects are not sufficient to classify Potassium acetate as eye irritant, and since it serves as a read-across substance for Manganese (II) acetate, the latter does not need to be classified, too.
Executive summary:

A solution of Potassium acetate was tested in a OECD 405 guideline study in rabbits for its eye irritating potency. The the individual mean scores were less than 2.5, the criteria for classification as R36 (i.e. H319) 'irritating to eyes' in rabbits are not met by the results of this test. Hence, the effects are not sufficient to classify Potassium acetate as eye irritant, and since it serves as a read-across substance for Manganese (II) acetate, the latter does not need to be classified, too.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For both required endpoints, i.e. Skin irritation /corrosion and eye irritation, each three in vivo studies are available on Read-across substances of Manganese (II) acetate. Although only assessed with Klimisch 4, the results are consistent and in the scientifically expected range, taking into account the pH value in a physiological range and the negligible reactivity of the single ions, which would not lead to any irritating effects. This was confirmed by the outcome of each study: No irritating effects were seen or slightly irritating effects to the maximum, which were not destinctive enough to justify classification. Hence, since all read-across substances do not need to be classified, Manganese (II) acetate does not need to be classified, too, neither as skin nor eye irritant, neither according Regulation 1272/2008/EC nor Directive 67/548/EEC.

So it can be concluded that no datagaps are present, due to the consistency and the nature of the results, and in regard to animal welfare, no further in vivo studies need to be performed. Additionally, since all six studies are in vivo studies or even human data, which are always considered more reliable as in vitro studies, no in vitro study needs to be performed, too, and also her no datagap was identified.


Justification for selection of skin irritation / corrosion endpoint:
There are three equally reliable studies on read-across substances available, i.e. Acetic acid, Manganese Carbonate and Potassium Acetate.
Since it is most likely that irritating effects, if any, would arise from the Acetate anion, and manganese (II) acetate is a salt and not a free acid, the greatest overlap in structural similarities is given with Potassium acetate.
In general, the valence state of the cation and hence the amount of acetate anions does not limit the suitability for read-across, since the salt would be solved immediately when coming into contact with moistured skin or eyes.
Additionally, the results gained from all substances are consistent and lead all to the conclusion that Manganese (II) acetate does not need to be classified as irritating to the skin, so the endppoint selection has no influence on the outcome of the conclusion not to classify Manganese (II) acetate.

Justification for selection of eye irritation endpoint:
There are three equally reliable studies on read-across substances available, i.e. Manganese Carbonate, Sodium acetate and Potassium Acetate.
Since it is most likely that irritating effects, if any, would arise from the Acetate anion, the greater overlap in structural similarities is given with one of the available acetates. Taking into account the size of the Manganese cation, the greatest similarity can be expected with Potassium acetate.
In general, the valence state of the cation and hence the amount of acetate anions does not limit the suitability for read-across, since the salt would be solved immediately when coming into contact with moistured skin or eyes.
Additionally, the results gained from all substances are consistent and lead all to the conclusion that Manganese (II) acetate does not need to be classified as irritating to the skin, so the endppoint selection has no influence on the outcome of the conclusion not to classify Manganese (II) acetate.

Justification for classification or non-classification

Each of the three studies on Skin irritation / corrosion and Eye irritation revealed independently consistent results on Read-across substances. No irritating effects were seen or slightly irritating effects to the maximum, which were not destinctive enough to justify classification. Hence, since all read-across substances do not need to be classified, Manganese (II) acetate does not need to be classified, too, neither as skin nor eye irritant, neither according Regulation 1272/2008/EC nor Directive 67/548/EEC.