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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin irritation/corrosion:

Experimental studies with Fatty acids, C16-18, zinc salts are available and do not indicate skin irritating or corrosive potential.

 

Eye irritation/damage:

Experimental studies with Fatty acids, C16-18, zinc salts are available and do not indicate potential for eye irritation or damage.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was peer-reviewed and rated reliable within the framework of the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004. In accordance with Section 1 (0.5), Annex I of Regulation (EC) No 1907/2006 (REACH), this study was considered reliable with restrictions.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Draize et al. (1944) Methods for the study of irritation and toxicity of substances, applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 82, 377.
Principles of method if other than guideline:
The test item was applied in a single dose under occlusive conditions for 4 hours. The method of Draize (Draize, J.H., Woodard, G., and Calvery, H.O. (1944). Methods for the study of irritation and toxicity of substances, applied topically to the skin and mucous membranes, J. Pharmacol. Exp. Ther. 82, 377.) was used.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Albino rabbits were used.
No further infromation on the test animals was stated.
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml (0.5 g) of zinc stearate
- Concentration: 100 %
No further information on the amounts/concentration applied was stated.
Duration of treatment / exposure:
4 hours
Observation period:
not stated
Number of animals:
6 rabbits
Details on study design:
It was stated that the method of Draize was used.
Zinc stearate was applied in a single dose under occlusive conditions. The wrapping and test material were removed at 4 hours and the sites scored for erythema and oedema at 4 and 48 hours.
No further information on the study design was stated.
Irritation parameter:
other: Primary Irritation Index (PII)
Time point:
other: 4 and 48 hours
Score:
0
Max. score:
8
Remarks on result:
other: PII score of 0 translates into an overall irritation score of 0 according to OECD 404 (2002). Zinc stearate was not corrosive under 49 CFR 173.240(a)(1).
Irritant / corrosive response data:
Zinc stearate was not corrosive under 49 CFR 173.240(a)(1).
Interpretation of results:
other: neither corrosive nor irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Within the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004, this study was used for classification and labelling with the following conclusion:
"Zinc distearate is not corrosive to skin."
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was peer-reviewed and rated reliable within the framework of the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004. In accordance with Section 1 (0.5), Annex I of Regulation (EC) No 1907/2006 (REACH), this study was considered reliable with restrictions.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Draize et al. (1944) Methods for the study of irritation and toxicity of substances, applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 82, 377.
Principles of method if other than guideline:
The test item was applied under occlusive conditions to the abraded and intact skin of rabbits for 24 hours. The method of Draize (Draize, J.H., Woodard, G., and Calvery, H.O. (1944). Methods for the study of irritation and toxicity of substances, applied topically to the skin and mucous membranes, J. Pharmacol. Exp. Ther. 82, 377.) was used.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
Albino rabbits were used.
No further infromation on the test animals was stated.
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/kg zinc distearate was applied undiluted
- Concentration: 100 %
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
24 hours
Observation period:
not stated
Number of animals:
6 rabbits
Details on study design:
It was stated that the method of Draize was used.
The test material was applied under occlusive conditions to the abraded and intact skin. The sites were unwrapped and examinedand scored for erythema and oedema at 24 and 72 hours.
No further information on the study design was stated,
Irritation parameter:
other: Primary irritation index (PII)
Basis:
mean
Time point:
other: 24/72 h
Score:
0
Max. score:
8
Remarks on result:
other:
Remarks:
PII score of 0 translates into an overall irritation score of 0 according to OECD 404 (2002). Zinc stearate was not irritating
Irritant / corrosive response data:
Zinc stearate was not irritating
Other effects:
not stated
Interpretation of results:
GHS criteria not met
Conclusions:
Zinc stearate was not irritating.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.

This conclusion is in accordance with EU RAR.
Conclusions of EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004:
"Limited data on zinc distearate indicate no skin and eye irritating potential. Based on the accepted derogation and the fact that both zinc phosphate and zinc oxide is not skin irritating, it is consequently concluded that zinc distearate is not likely to have skin irritation potential and, therefore does not need to be classified/labelled. This is supported by the fact that the use of zinc distearate in pharmaceutical and cosmetic preparations is not associated with irritation in humans."

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was peer-reviewed and rated reliable within the framework of the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004". In accordance with Section 1 (0.5), Annex I of Regulation (EC) No 1907/2006 (REACH), this study was considered reliable with restrictions.
Qualifier:
according to guideline
Guideline:
other: Draize et al. (1944) Methods for the study of irritation and toxicity of substances, applied topically to the skin and mucous membranes. J. Pharmacol. Exp. Ther. 82, 377.
Principles of method if other than guideline:
100 % zinc stearate was applied to the eyes of rabbits. Observations were made on days 1 and 2.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Rabbits were used.
No further information on the test animals was stated.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 % concentration of zinc stearate was applied to the eyes of the rabbits.
No further information on the amount/concentration applied was stated.
Observation period (in vivo):
Days 1 and 2
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
Eyes were not unrinsed.
The method of Draize was used in this study.
No further information on the study design was stated.
Irritation parameter:
other: Primary irritation index (PII)
Basis:
mean
Time point:
other: day 1
Score:
2
Max. score:
110
Irritation parameter:
other: Primary irritation index (PII)
Basis:
mean
Time point:
other: day 2
Score:
0
Max. score:
110

A 100 % concentration of zinc stearate caused minimal irritation.

Interpretation of results:
GHS criteria not met
Conclusions:
Within the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004, this study was used for classification and labelling with the following conclusion: "Limited data on zinc distearate indicate no skin and eye irritating potential. Based on the accepted derogation, and the fact that both zinc phosphate and zinc oxide are not eye irritating and zinc oxide is not skin irritating, 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. This is supported by the fact that the use of zinc distearate in pharmaceutical and cosmetic preparations is not associated with irritation in humans."
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was peer-reviewed and rated reliable within the framework of the EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004". In accordance with Section 1 (0.5), Annex I of Regulation (EC) No 1907/2006 (REACH), this study was considered reliable with restrictions.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Draize, J.H. (1959). Dermal toxicity. Appraisal of the safety of chemicals in foods, drugs, and cosmetics. Assoc. of Food and Drug Officials of the U.S., compiled by the Div. of Pharm., Food and Drug Admin., Dept. of Health, Education and Welfare, Austin,
Principles of method if other than guideline:
100 % zinc stearate was applied to the eyes of albino rabbits. Observations were made on days 1,2, and 3.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Albino rabbits were used.
No further information on the test animals was stated.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (100 % concentration) of zinc stearate was applied.
No further information on the amount/concentration applied was stated.
Observation period (in vivo):
Days 1, 2, and 3
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
Eyes were not rinsed.
The ocular irritation was scored according to the system of Draize on days 1, 2, and 3.
No further information on the study design was stated.
Irritation parameter:
other: Primary irritation index (PII)
Time point:
24/48/72 h
Score:
0
Max. score:
110
Remarks on result:
other: PII score of 0 translates into a score of 0 according to OECD 405 (2002). 0.1 g (100 % concentration) of zinc stearate caused no eye irritation.
Irritant / corrosive response data:
0.1 g (100 % concentration) of zinc stearate caused no eye irritation.
Interpretation of results:
GHS criteria not met
Conclusions:
0.1 g (100 % concentration) of zinc stearate caused no eye irritation.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.

This conclusion is in accordance with EU RAR.
Conclusions of EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN. Institute for Health and Consumer Protection. ECB - Existing Substances. Final Report, 2004:"Limited data on zinc distearate indicate no skin and eye irritating potential. Based on the
accepted derogation, and the fact that both zinc phosphate and zinc oxide are not eye irritating and zinc oxide is not skin irritating, 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.
This is supported by the fact that the use of zinc distearate in pharmaceutical and cosmetic preparations is not associated with irritation in humans."
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

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

Additional information

Fatty acids, C16-18, zinc salts

Experimental studies with Fatty acids, C16-18, zinc salts are available and do not indicate skin irritating or corrosive potential as well as potential for eye irritation or damage.

Additionally, information from structurally similar zinc salts of fatty acids were taken into account in order to substantiate the conclusion above.

Fatty acids, C16-18, zinc salts is a zinc salt of a fatty acid containing 16-18 C-atoms. Thus, data for the substance under consideration as well as read-across of data available for zinc salts of shorter-chained (C8, C12) fatty acids based on structural similarity, water solubility and zinc content in a conservative, worst-case approach is assumed to adequately describe the toxicological potential of fatty acids, C16-18, zinc salts.

  

Octanoic acid, zinc salt, basic (C8) is not irritating to the skin and zinc dilaurate (C12) is not irritating to the eye. In addition, the results of the histopathological examination of lung tissue acutely exposed to zinc dilaurate (C12) via inhalation (OECD 436 test) do not indicate an potential for respiratory tract irritation.

Thus, no skin, eye and respiratory irritancy or corrosivity is expected for substance Fatty acids, C16-18 zinc salts. Thus, classification according to Regulation (EC) 1272/2008 and its subsequent amendments is not required. This conclusion is in line with the conclusion of an EU risk assessment carried out on 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."

Justification for classification or non-classification

According to substance specific in vivo data on skin and eye irritation/corrosion, Fatty acids, C16 -18, zinc salts is not irritating or corrosive. According to the criteria of regulation (EC) 1272/2008 and its subsequent amendments, substance Fatty acids, C16 -18, zinc salts does not have to be classified and has no obligatory labelling requirement for skin, eye or respiratory irritation or corrosion.