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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No irritation /corrosion studies with substance Fatty acids, C18-24, zinc salts are available. The irritation / corrosion potential will be addressed with skin irritation /corrosion and eye irritation studies on structural analog Fatty acid(s), zinc salts, e.g. zinc salts of shorter-chained (C8) and similar chained (C16-18) fatty acids, which all demonstrated the lack of an irritation/corrosion potential. This is supported by the results of the histopathological examination of lung tissue acutely exposed to zinc dilaurate (Fatty acid C12, zinc salt) via inhalation (OECD 436 test), which do not indicate an irritative potential of fatty acid zinc salts.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that key and supporting source substance(s) and target substance have a similar skin irritation /corrosion potential based on their structural similarity.

2. SOURCE AND TARGET CHEMICALS COMPOSITION
Source(s) and target are all fatty acid(s) zinc salts. They have a very close structural similarity only varying in their fatty acids chain length distribution and consequential minor variations in their relative zinc content.

2.1. Composition of supporting source substance Octanoic acid, zinc salt, basic / 90480-58-3 /291-793-4:
- Octanoic acid, zinc salt, basic / 90480-58-3 /291-793-4: >=80.0 - <=100.0% (w/w)
Only components which do not affect the classification may be present in the target substance.

2.2.. Composition of supporting source substance Fatty Acids, C16-18, zinc salts / 91051-01-3 / 293-049-4:
- Fatty Acids, - zinc dipalmitate / zinc dihexadecanoate / 4991-47-3 / 225-652-5: >=20.0 - <=65.0% (w/w)
- zinc distearate / zinc dioctadecanoate / 557-05-1 / 209-151-9: >=35.0 - <=80.0% (w/w)
- Fatty Acids, >C18, zinc salts: <= 6.0% (w/w)
- Fatty acids, C16-18 / Fatty acids, C16-18 / 67701-03-5 / 266-928-5: <= 3.0% (w/w)
- water / dihydrogen oxide / 7732-18-5 / 231-791-2: <= 2.0% (w/w)
Only components which do not affect the classification may be present in the source substance.

2.3. Composition of target substance Fatty acids, C18-24, zinc salts / 84776-57-8 / 283-985-1:
- zinc distearate / zinc dioctadecanoate / 557-05-1 / 209-151-9: >=30.0 - <=45.0% (w/w)
- zinc diicosanoate / zinc diicosanoate / 7278-04-8 / 230-693-7: >=5.0 - <=15.0% (w/w)
- zinc didocosanoate / zinc didocosanoate / 16529-65-0 / 240-597-7: >=40.0 - <=55.0% (w/w)
- Zinc salts of fatty acids C24: <= 10.0% (w/w)
- Fatty acids, C18-24 / 98106-57-1 / 308-578-9: <= 5.0% (w/w)
- water / dihydrogen oxide / 7732-18-5 / 231-791-2: <= 2.0% (w/w)
Only components which do not affect the classification may be present in the target substance.

3. ANALOGUE APPROACH JUSTIFICATION
Source(s) and target have a very close structural similarity only varying in their fatty acids chain length distribution and consequential minor variations in their relative zinc content. They are produced by the oleochemistry sector, starting from natural fatty materials and consist of natural fatty acids and zinc. Generally, shorter chained fatty acids are associated with a higher solubility and acidity. However, octanoic acid, zinc salt, basic (C8) was not irritating to the skin in an in vivo test. The missing skin irritation / corrosion potential of fatty acids zinc salts is supported by the data on substance Fatty acid, C16-18, zinc salts which was testes with negative results in vivo and in vitro skin irritation /corrosion tests and the results of the histopathological examination of lung tissue acutely exposed to zinc dilaurate (Fatty acid C12, zinc salt) via inhalation (OECD 436 test), which also do not indicate an irritative potential of fatty acids zinc salts.

Thus, read-across of data available for a zinc salt of a shorter-chained (C8) fatty acid based on structural similarity, water solubility and zinc content is a conservative, worst-case approach and is assumed to adequately describe the skin irritation /corrosion potential of Fatty acids, C18-24, zinc salts. Further on, data available for zinc salts of similar chained (C16-18) fatty acids are given as supporting data.

Therefore, read-across from the existing skin irritation /corrosion data on the source substance(s) is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.5.1 of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.

Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
data waiving: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
by read-across to Octanoic acid, zinc salt, basic / 90480-58-3 / 291-793-4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
by read-across to Octanoic acid, zinc salt, basic / 90480-58-3 / 291-793-4
Interpretation of results:
GHS criteria not met
Remarks:
by read-across to structural analog Fatty acid(s), zinc salts
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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that key and supporting source substance(s) and target substance have a similar eye irritaion potential based on their structural similarity. t

2. SOURCE AND TARGET CHEMICALS COMPOSITION
Source(s) and target are all fatty acid(s) zinc salts. They have a very close structural similarity only varying in their fatty acids chain length distribution and consequential minor variations in their relative zinc content.

2.1. Composition of key source substance zinc didodecanoate / 35674-68-1 / 219-518-5:
- zinc dilaurate / zinc didodecanoate / 2452-01-9 / 219-518-5: >=95.0 - <=100.0% (w/w)
- fatty acids, - fatty acids, >C12, zinc salts / fatty acids, >C12, zinc salts: <=5.0% (w/w)
- lauric acid / lauric acid / 143-07-7 / 205-582-1: <=2.0% (w/w)
- water / dihydrogen oxide / 7732-18-5 / 231-791-2: <=1.0% (w/w)
Only components which do not affect the classification may be present in the target substance.

2.2.1 Composition of supporting source substance Fatty Acids, C16-18, zinc salts / 2452-01-9 / 293-049-4:
- Fatty Acids, - zinc dipalmitate / zinc dihexadecanoate / 4991-47-3 / 225-652-5: >=20.0 - <=65.0% (w/w)
- zinc distearate / zinc dioctadecanoate / 557-05-1 / 209-151-9: >=35.0 - <=80.0% (w/w)
- Fatty Acids, >C18, zinc salts: <= 6.0% (w/w)
- Fatty acids, C16-18 / Fatty acids, C16-18 / 67701-03-5 / 266-928-5: <= 3.0% (w/w)
- water / dihydrogen oxide / 7732-18-5 / 231-791-2: <= 2.0% (w/w)
Only components which do not affect the classification may be present in the source substance.

2.2.2. Composition of supporting source substance zinc dioctanoate / zinc dioctanoate / 557-09-5 / 209-156-64
no further data available

2.3. Composition of target substance Fatty acids, C18-24, zinc salts / 84776-57-8 / 283-985-1:
- zinc distearate / zinc dioctadecanoate / 557-05-1 / 209-151-9: >=30.0 - <=45.0% (w/w)
- zinc diicosanoate / zinc diicosanoate / 7278-04-8 / 230-693-7: >=5.0 - <=15.0% (w/w)
- zinc didocosanoate / zinc didocosanoate / 16529-65-0 / 240-597-7: >=40.0 - <=55.0% (w/w)
- Zinc salts of fatty acids C24: <= 10.0% (w/w)
- Fatty acids, C18-24 / 98106-57-1 / 308-578-9: <= 5.0% (w/w)
- water / dihydrogen oxide / 7732-18-5 / 231-791-2: <= 2.0% (w/w)
Only components which do not affect the classification may be present in the target substance.

3. ANALOGUE APPROACH JUSTIFICATION
Source(s) and target have a very close structural similarity only varying in their fatty acids chain length distribution and consequential minor variations in their relative zinc content. They are produced by the oleochemistry sector, starting from natural fatty materials and consist of natural fatty acids and zinc. Generally, shorter chained fatty acids are associated with a higher solubility and acidity. However, zinc didodecanoate (C12) was not irritating to the eyes an in vivo test. The missing eye irritation potential of fatty acids zinc salts is supported by the data on substances Zinc dioctanoate and Fatty acid, C16-18, zinc salts which were tested with also negative results in vivo eye irritation tests and the results of the histopathological examination of lung tissue acutely exposed to zinc dilaurate (Fatty acid C12, zinc salt) via inhalation (OECD 436 test), which also do not indicate an irritative potential of fatty acids zinc salts.

Thus, read-across of data available for a zinc salt of a shorter-chained (C12) fatty acid based on structural similarity, water solubility and zinc content is a conservative, worst-case approach and is assumed to adequately describe the eye irritation potential of Fatty acids, C18-24, zinc salts. Further on, data available for zinc salts of similar chained (C16-18) fatty acids and one a study with shorter-chained zinc dioctanoate (C8, study with reliability 4 as only a short report is available) are given as supporting data.


Therefore, read-across from the existing eye irritation data on the source substance(s) is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.5.1 of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Irritation parameter:
iris score
Basis:
mean
Remarks:
of three
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other:
Remarks:
by read-across to zinc didodecanoate / 2452-01-9 / 219-518-5
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of three animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
by read-across to zinc didodecanoate / 2452-01-9 / 219-518-5
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of tree animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other:
Remarks:
by read-across to zinc didodecanoate / 2452-01-9 / 219-518-5
Interpretation of results:
GHS criteria not met
Remarks:
by read-across to structural analog Fatty acid(s), zinc salts
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

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

Additional information

By read-across to structural analog fatty acid(s), zinc salts, substance Fatty acids, C18-24 zinc salts is not expected to have an irritation or corrosion potential.

Source(s) and target have a very close structural similarity only varying in their fatty acids chain length distribution and consequential minor variations in their relative zinc content. They are produced by the oleochemistry sector, starting from natural fatty materials and consist of natural fatty acids and zinc. Generally, shorter chained fatty acids are associated with a higher solubility and acidity. However, octanoic acid, zinc salt, basic (C8) was not irritating to the skin in an in vivo test. The missing skin irritation / corrosion potential of fatty acids zinc salts is supported by the data on substance Fatty acid, C16-18, zinc salts which was testes with negative results in vivo and in vitro skin irritation /corrosion tests. Zinc didodecanoate (C12) was not irritating to the eyes in an in vivo test. The missing eye irritation potential of fatty acids zinc salts is supported by the data on substances Zinc dioctanoate and Fatty acid, C16-18, zinc salts which were tested with also negative results in vivo eye irritation tests. Further on the results of the histopathological examination of lung tissue acutely exposed to zinc dilaurate (Fatty acid C12, zinc salt) via inhalation (OECD 436 test), which also do not indicate an irritative potential of fatty acid zinc salt, substantiate also the conclusion on a missiing irritative potential of fatty acid zinc salts.

 

Thus, a lack of skin, eye and respiratory irritancy is considered for substance Fatty acids, C18-24 zinc salts, and classification according to Regulation (EC) 1272/2008 is not required.

 

This conclusion is in line with the conclusion of an EU risk assessment carried out on the structural analogue substance Fatty acids, C16-18, zinc salts (i.e. zinc stearate) within the framework of EU Existing Chemicals Regulation 793/93 (EU RAR Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II–Human Health. EUR 21168 EN (http://echa.europa.eu/documents/10162/08799aec-42c5-44e0-9969-baa022c66db1): "It is consequently concluded that zinc distearate is not likely to have eye and skin irritation potential and, therefore does not need to be classified/labelled... Zinc distearate is not corrosive to skin or eyes." A similar lack of an irritation or corrosion potential is considered for substance Fatty acids, C18-24, zinc salts.

Justification for classification or non-classification

By read-across to structural analog fatty acid(s), zinc salts, substance Fatty acids, C18-24, zinc salts is not expected to have an eye, skin or respiratory tract irritation or corrosion potential.

According to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations, substance Fatty acids, C18-24, zinc salts does not have to be classified for skin, eye or respiratory irritation.

According to the criteria of REGULATION (EC) No 1272/2008, substance Fatty acids, C18-24, zinc salts does not have to be classified and has no obligatory labelling requirement for skin, eye or respiratory irritation.

.