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EC number: 266-936-9 | CAS number: 67701-12-6 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid zinc salt and SDA Reporting Number: 04-006-09.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion:
No skin irritation/corrosion studies with Fatty acids, C14 -18 and C16 -18 unsatd., zinc salts are available, thus the skin irritation or corrosion potential will be addressed with existing data on structurally similar zinc salts of fatty acids.
Fatty acids, C14 -18 and C16 -18 unsatd. is not expected to show irritating or corrosive effects to the skin, since experimental studies with the stucturally related substance Fatty acids, C16-18, zinc salts and the shorter-chained substance Octanoic acid, zinc salt, basic do not indicate skin irritating or corrosive potential.
Eye damage:
No eye irritation studies with Fatty acids, C14 -18 and C16 -18 unsatd., zinc salts are available, thus the eye irritation or corrosion potential will be addressed with existing data on structurally similar zinc salts of fatty acids.
Fatty acids, C14 -18 and C16 -18 unsatd., zinc salt is not expected to be damaging to the eye, since experimental studies with the structurally related substance Fatty acids, C16-18, zinc salts and Zinc dilaurate do not indicate potential for eye irritation or corrosion.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Justification for type of information:
- Fatty acids, C14-18 and C16-18 unsatd., zinc salts is a zinc salt of a fatty acid containing 14-18 C-atoms. Thus, read-across of data available for zinc salts of shorter-chained (C8, 12) and similar chained (C16-18) 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, C14-18 and C16-18-unsatd., zinc salts.
- 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:
- 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:
"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.
- Justification for type of information:
- Fatty acids, C14-18 and C16-18 unsatd., zinc salts is a zinc salt of a fatty acid containing 14-18 C-atoms. Thus, read-across of data available for zinc salts of shorter-chained (C8, 12) and similar chained (C16-18) 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, C14-18 and C16-18-unsatd., zinc salts.
- 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 examined and 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)
- Time point:
- other: 24 and 72 hours
- Score:
- 0
- 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 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:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992-10-20 to 1992-10-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Justification for type of information:
- Fatty acids, C14-18 and C16-18 unsatd., zinc salts is a zinc salt of a fatty acid containing 14-18 C-atoms. Thus, read-across of data available for zinc salts of shorter-chained (C8, 12) and similar chained (C16-18) 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, C14-18 and C16-18-unsatd., zinc salts.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1981-05-12
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: Kleinrussen, CHbb:HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae GmbH, Biberach/D.
- Age at study initiation: approx. 9 months
- Weight at study initiation: approx. 2590 g
- Housing: individual accommodation in cages
- Diet (ad libitum): Ssniff rabbit diet K4 (Ssniff GmbH, Soest/D, Batch: 770992/09)
- Water (ad libitum): tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature: approx. 20-25 °C
- Relative humidity: approx. 45-70 %
- Air changes: at least eight per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the undiluted test substance Stabiol VZN 1950 was applied at the dose level of 0.5 g per animal. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after exposure
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: the flank of each experimental animal was sheared approx. 24 hours prior to the application with an electric clipper. Animals with intact and healthy skin were used in the test.
The semi-occlusive exposure was performed by means of a 6 cm^2 adhesive air- and vapour permeable gauze-patch which was fixed by a hypoallergic adhesive gauze-bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposure was terminated after four hours by removing the patch and cleaning the relevant skin from the residual test substance.
SCORING SYSTEM: according to Draize scale - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No dermal effects were observed at all experimental animals up to 72 hours after exposure.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Octanoic acid, zinc salt, basic is not irritating to the skin.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
- Justification for type of information:
- Fatty acids, C14-18 and C16-18 unsatd., zinc salts is a zinc salt of a fatty acid containing 14-18 C-atoms. Thus, read-across of data available for zinc salts of shorter-chained (C8, 12) and similar chained (C16-18) 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, C14-18 and C16-18-unsatd., zinc salts.
- 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:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Remarks on result:
- other: PII score of 2 translates into "Practically Non-Irritating". 100 % zinc stearate is "practically non-irritating".
- Irritation parameter:
- other: Primary irritation index (PII)
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: PII score of 0 translates into a score of 0 according to OECD 405 (2002). 100 % zinc stearate caused no eye 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.
- Justification for type of information:
- Fatty acids, C14-18 and C16-18 unsatd., zinc salts is a zinc salt of a fatty acid containing 14-18 C-atoms. Thus, read-across of data available for zinc salts of shorter-chained (C8, 12) and similar chained (C16-18) 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, C14-18 and C16-18-unsatd., zinc salts.
- 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
- 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:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2011-12-08 to 2011-12-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Fatty acids, C14-18 and C16-18 unsatd., zinc salts is a zinc salt of a fatty acid containing 14-18 C-atoms. Thus, read-across of data available for zinc salts of shorter-chained (C8, 12) and similar chained (C16-18) 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, C14-18 and C16-18-unsatd., zinc salts.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted April 24, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-11-12
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH Co. KG, Branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 4.5- 5.5 months
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: animals were kept singly in cages of 380 mm x 425mm x 600 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 16352 Schönwalde, Germany) during the acclimatisation period and after the 8 hours period in restrainers (for 8 hours following test item application the animals were kept singly in restrainers).
- Diet (ad libitum): commercial diet, ssniff K-H V2333 (Ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum before and after the exposure period): tap water
- Acclimation period: at least 20 adaptation days
ENVIRONMENTAL CONDITIONS:
- Temperature: 20°C ± 3°C (maximum range)
- Relative humidity: 30% to 70 % (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL:
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 1 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- INITIAL AND CONFORMATORY TEST
The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.
The test item were administered into one eye each of three animals. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
APPLICATION
- 100 mg of the test item were administered into one eye each of three animals. The volume of particulates was measured after gently compacting them, e.g. by tapping the measuring container. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were rinsed with portions of 20 mL 0.9% aqueous NaCl solution, each.
- Time after start of exposure: 1 hour after administration
SCORING SYSTEM: according to the Draize scale
Any further lesions are listed.
TOOL USED TO ASSESS SCORE: the eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
24 hours and after administration, fluorescein (Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 79108 Freiburg, Germany) was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
OBSERVATIONS
Body weight of all animals was measured at the beginning of the study. Behaviour and food consumption were monitored. - Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0 - 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Conjunctival redness (grade 1) was observed in all animals for 60 minutes, and in one animal for 24 hours after the instillation.
The corneae and irises were not affected by instillation of the test item.
The fluorescein test performed 24 hours after instillation did not reveal any changes. - Other effects:
- There were no systemic intolerance reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is non-irritating to the eyes.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the substance is not classified as an eye irritant.
Referenceopen allclose all
A 100 % concentration of zinc stearate caused minimal irritation and is considered "practically non-irritating".
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, C14 -18 and C16 -18 unsatd., zinc salts
Fatty acids, C14 -18 and C16 -18 unsatd., zinc salts is a zinc salt of a fatty acid containing 14-18 C-atoms. Thus, read-across of data available for zinc salts of shorter-chained (C8, 12) and similar chained (C16-18) 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, C14-18 and C16-18-unsatd., zinc salts.
Experimental studies with the structurally related substance Fatty acids, C16-18, zinc salts and shorter-chained zinc salts (C8, C12) are available and do not indicate skin and eye irritation or corrosive potential. Thus, no skin, eye and respiratory irritancy or corrosivity is expected for substance Fatty acids, C14 -18 and C16 -18 unsatd., 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 the structurally related 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."
Justification for classification or non-classification
Fatty acids, C14 -18 and C16 -18 unsatd., zinc salts is not expected to show irritating or corrosive effects to skin or eyes, since experimental studies with the stucturally related substance Fatty acids, C16-18, zinc salts and the shorter-chained substances Zinc dilaurate and Octanoic acid, zinc salt, basic do not indicate skin or eye irritating or corrosive potential.
Thus, according to the criteria of regulation (EC) 1272/2008 and its subsequent amendments, substance Fatty acids, C14 -18 and C16 -18 unsatd., zinc salts does not have to be classified and has no obligatory labelling requirement for skin, eye or respiratory irritation or corrosion.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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