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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Based on the experimental results on analogue substances, the weight of evidence approach was applied and the substance Fatty acids, C16-18 (even numbered), ammonium salts was determined to be non-irritant to the skin.

Eye irritation: Based on the experimental results on analogue substances, the weight of evidence approach was applied and the substance Fatty acids, C16-18 (even numbered), ammonium salts was determined to be non-irritant to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
An in vitro study does not need to be conducted beacuse adequate data from in vivo skin irritation studies are available.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. No data on GLP.
Principles of method if other than guideline:
-Principle of test: Results according to OECD scoring system. Limited data provided on the test method. An skin irritation test was performed on ammonium stearate. The test material was applied to rabbits in a single dose under occlusive conditions.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Test item concentration: 100%.
Single dose.
Details on study design:
The test material was applied in a single dose under occlusive conditions.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.62
Remarks on result:
no indication of irritation

The primary dermal irritation index (PDII) for ammonium stearate was determined to be 0.62.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Ammonium stearate is non-irritant for skin (PII=0.62).
Executive summary:

A skin irritation test was performed on ammonium stearate at a concentration of 100% on rabbits. Test material was applied in a single dose under occlusive conditions. The primary irritation index (P.I.I.) was determined to be 0.62. The substance was non-irritant for skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Review Article. No individual scores were reported. No data on GLP.
Principles of method if other than guideline:
-Principle of test: Two studies were performed using four and three restrained guinea pigs, respectively, with four dipped sites per animal, in which the animals received topical applications of 0.1 mL of 12% Ammonium Lactate lotion, pH 5.0-5.5, and 0.05 mL of Oxsoralen (as a positive control) on two contralateral sites. The right side of each animal was shielded with cardboard and the left side was uncovered. The animals were exposed to UVA light 15-20 min after dosing; the animals were examined after 24 h.
GLP compliance:
not specified
Species:
guinea pig
Strain:
not specified
Type of coverage:
open
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
0.1 mL of 12% Ammonium Lactate lotion, pH 5.0-5.5, and 0.05 mL of Oxsoralen (as a positive control) on two contralateral sites.
Duration of treatment / exposure:
24 hours
Observation period:
24 hours
Number of animals:
Seven animals.
Details on study design:
The right side of each animal was shielded with cardboard and the left side was uncovered. The animals were exposed to UVA light 15-20 min after dosing; the animals were examined after 24 h.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Ammonium Lactate lotion did not produce erythema at either the irradiated or non-irradiated sites.
Numerical results are not provided.

Ammonium Lactate lotion did not produce erythema at either the irradiated or non-irradiated sites.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Ammonium Lactate lotion did not produce erythema at either the irradiated or non-irradiated sites.
Executive summary:

Two studies were performed using four and three restrained guinea pigs, respectively, with four dipped sites per animal, in which the animals received topical applications of 0.1 mL of 12% Ammonium Lactate lotion, pH 5.0-5.5, and 0.05 mL of Oxsoralen (as a positive control) on two contralateral sites. The right side of each animal was shielded with cardboard and the left side was uncovered. The animals were exposed to UVA light 15-20 min after dosing; the animals were examined after 24 h. In both studies, Ammonium Lactate lotion did not produce erythema at either the irradiated or non-irradiated sites. The positive control produced severe erythema at the irradiated site, but no reactions were observed at the non-irradiated sites.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. No data on GLP.
Principles of method if other than guideline:
-Principle of test: Results according to OECD scoring system. Test method according to Single insult occlusive patch test (24h exposure period). 6 rabbits were exposed to a single dose of 0.5 ml Palmitic acid as commercially supplied. Patches were applied to intact and abraded skin sites.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Albino
Type of coverage:
occlusive
Preparation of test site:
abraded
Remarks:
(intact and abraded skin sites)
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Test item concentration: as commercially supplied.
Single dose of 0.5 ml.
Duration of treatment / exposure:
24 hours.
Number of animals:
6 rabbits per dose
Details on study design:
6 rabbits were exposed to a single insult occlusive patch of 0.5 ml palmitic acid as commercially supplied. Patches were applied to intact and abraded skin sites for 24 hours.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Palmitic acid was not irritating to the skin under test conditions.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Palmitic acid was non-irritant for skin (PII=0.0) under test conditions.
Executive summary:

A skin irritation test was performed on palmitic acid as commercially supplied. 6 rabbits were exposed to a single insult occlusive patch of 0.5 ml palmitic acid. Patches were applied to intact and abraded skin sites for 24 hours. The primary irritation index (P.I.I.) was determined to be 0.0 and therefore, the test item palmitic acid was determined to be non-irritant for skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. No data on GLP.
Principles of method if other than guideline:
-Principle of test: Results according to OECD scoring system. Test method according to Single insult occlusive patch test (24h exposure period). 6 rabbits were exposed to a single dose of 0.5 ml Stearic acid as commercially supplied. Patches were applied to intact and abraded skin sites.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Albino
Type of coverage:
occlusive
Preparation of test site:
abraded
Remarks:
(intact and abraded skin sites)
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Test item concentration: as commercially supplied.
Single dose of 0.5 ml.
Duration of treatment / exposure:
24 hours.
Number of animals:
6 rabbits per dose
Details on study design:
6 rabbits were exposed to a single insult occlusive patch of 0.5 ml stearic acid as commercially supplied. Patches were applied to intact and abraded skin sites for 24 hours.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation

Stearic acid was not irritating to the skin under test conditions.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Stearic acid was non-irritant for skin (PII=0.0) under test conditions.
Executive summary:

A skin irritation test was performed on stearic acid as commercially supplied. 6 rabbits were exposed to a single insult occlusive patch of 0.5 ml stearic acid. Patches were applied to intact and abraded skin sites for 24 hours. The primary irritation index (P.I.I.) was determined to be 0.0 and therefore, the test item stearic acid was determined to be non-irritant for skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. Exposure limited to 2 hours. No data on GLP.
Principles of method if other than guideline:
-Principle of test: Results according to OECD scoring system. Test method according to Single insult occlusive patch test (2 hour exposure period). 9 rabbits were exposed to a single dose of approx. 0.5 ml Stearic acid as commercially supplied.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Albino
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Test item concentration: as commercially supplied.
Single dose of approx. 0.5 ml.
Duration of treatment / exposure:
2 hours.
Number of animals:
9 rabbits per dose
Details on study design:
9 rabbits were exposed to a single insult occlusive patch of approx. 0.5 ml stearic acid as commercially supplied. Patches were applied to skin sites for 2 hours.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.33
Remarks on result:
no indication of irritation

The primary dermal irritation index (PDII) for stearic acid was determined to be 0.33.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Stearic acid was non-irritant for skin (PII=0.33) under test conditions.
Executive summary:

A skin irritation test was performed on stearic acid as commercially supplied. 9 rabbits were exposed to a single insult occlusive patch of approx. 0.5 ml stearic acid. Patches were applied to skin sites for 2 hours. The primary irritation index (P.I.I.) was determined to be 0.33 and therefore, the test item stearic acid was determined to be non-irritant for skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. No data on GLP.
Principles of method if other than guideline:
-Principle of test: Results according to OECD scoring. Limited data provided on the test method. An skin irritation test was performed on sodium stearate. The test material was applied to rabbits in a single dose under occlusive conditions.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Test item concentration: 100%.
Single dose.
Number of animals:
6 albino rabbits.
Details on study design:
Material was applied in a single dose under occlusive conditions.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Sodium stearate was not irritating to the skin under test conditions.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Sodium stearate is non-irritant for skin (PII=0.0).
Executive summary:

A skin irritation test was performed on sodium stearate at a concentration of 100% on 6 albino rabbits. The material was applied in a single dose under occlusive conditions. The primary irritation index (P.I.I.) was determined to be 0.0. The substance was determined to be non-irritant for skin.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. No data on GLP.
Principles of method if other than guideline:
-Principle of test: The test was performed according to Draize method and evaluation. Magnesium stearate was applied under occlusive patch for 24 hours to 6 albino rabbits. One-half test sites were braded and the other one-hals were intact.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Test item concentration: 100%.
Single dose.
Number of animals:
6 albino rabbits.
Details on study design:
Test item was applied under occlusive patch for 24 hours. One-half test sites were braded and the other one-hals were intact.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation

Magnesium stearate was not irritating to the skin under test conditions.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Magnesium stearate is non-irritant for skin (PII=0.0).
Executive summary:

A skin irritation test was performed on magnesium stearate at a concentration of 100% on 6 albino rabbits. The material was applied in a single dose under occlusive conditions for 24 hours. The primary irritation index (P.I.I.) was determined to be 0.0. The substance was determined to be non-irritant for skin.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
An in vitro study does not need to be conducted beacuse adequate data from in vivo eye irritation studies are available.
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. No data on GLP.
Principles of method if other than guideline:
-Principle of test: The test was performed according to Draize method and evaluation. Rabbits were exposed to ammonium stearate at a concentration of 100%. Eyes were rinsed after treatment. Effects were observed for 72h.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Test item concentration: 100%
Observation period (in vivo):
72h
Details on study design:
Eyes were rinsed.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
1
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Ammonium stearate is not irritating for eyes.
Executive summary:

An Eye Irritation test according to Draize Method was performed on Ammonium stearate. Rabbits were exposed to a test item concentration of 100%. Eyes were rinsed after treatment and the scored were 3, 1 and 0 on days 1, 2 and 3 respectively. Based on these results, ammonium stearate was determined to be not irritating for eyes.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. No scoring results were reported. No data on GLP.
Principles of method if other than guideline:
-Principle of test: The test was performed according to Draize method and evaluation. 6 albino rabbits were exposed to a single installation of 0.1 ml palmitic acid as commercially supplied. The untreated eye was used as a negative control. Both eyes were observed for 72 hours.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Albino
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Test item concentration: As commercially supplied.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 albino rabbits
Details on study design:
Single installation of 0.1 ml volume of test item into 1 eye (untreated eye = control).
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Palmitic acid (as commercially supplied) was determined to be non-irritant to the eye.
Numerical results are not provided.

Palmitic acid (as commercially supplied) was determined to be non-irritant to the eye.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Palmitic acid (as commercially supplied) was determined to be non-irritant to the eye.
Executive summary:

An Eye Irritation test according to Draize Method was performed on Palmitic acid. 6 albino rabbits were exposed to a single installation of 0.1 ml of test item as commercially supplied. The untreated eye was used as a negative control. Both eyes were observed for 72 hours. Palmitic acid was determined to be non-irritant to the eye.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. No scoring results were reported. No data on GLP.
Principles of method if other than guideline:
-Principle of test: The test was performed according to Draize method and evaluation. 6 albino rabbits were exposed to a single installation of 0.1 ml of stearic acid as commercially supplied. The untreated eye was used as a negative control. Both eyes were observed for 72 hours.
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Albino
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Test item concentration: As commercially supplied.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 albino rabbits
Details on study design:
Single installation of 0.1 ml volume of test item into 1 eye (untreated eye = control).
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Stearic acid (as commercially supplied) was determined to be non-irritant to the eye.
Numerical results are not provided.

Stearic acid (as commercially supplied) was determined to be non-irritant to the eye.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Stearic acid (as commercially supplied) was determined to be non-irritant to the eye.
Executive summary:

An Eye Irritation test according to Draize Method was performed on Stearic acid. 6 albino rabbits were exposed to a single installation of 0.1 ml of test item as commercially supplied. The untreated eye was used as a negative control. Both eyes were observed for 72 hours. Stearic acid was determined to be non-irritant to the eye.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. No individual scores were reported. No data on GLP.
Principles of method if other than guideline:
-Principle of test: The test was performed according to Draize method and evaluation. 6 rabbits were exposed to a single installation of sodium stearate. The eyes were observed for 7 days.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Test item concentration: 100%
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
22
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
12
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 days
Score:
1
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Score:
1
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 4 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
On day one, 2/6 conjunctivae appeared necrotic.
Irritation was considered negligible by Day 4.

Eye irritation was considered negligible under test conditions.

Interpretation of results:
other: Negligible
Conclusions:
Eye irritating for sodium stearate was considered to be negligible.
Executive summary:

An Eye Irritation test according to Draize Method was performed on Sodium stearate. Rabbits were exposed to a test item concentration of 100%. On day one, 2/6 conjunctivae appeared necrotic. Scores were 22, 12, 3, 1 and 1 on days 1, 2, 3, 4 and 7 respectively. Eye irritation was considered to be negligible.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Scientific Panel Review Article. Results according to OECD scoring system, but without individual scores. No data on GLP.
Principles of method if other than guideline:
-Principle of test: The test was performed according to Draize method and evaluation. 6 rabbits were exposed to a single installation of magnesium stearate. The eyes were unrinsed and the effects were observed for 72 hours.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Test item concentration: 100%
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 albino rabbits
Details on study design:
Eyes were unrinsed.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
no indication of irritation

Magnesium stearate was determined to be not irritating to the skin.

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
Conclusions:
Magnesium stearate is not irritating for eyes.
Executive summary:

An Eye Irritation test according to Draize Method was performed on Ammonium stearate. 6 rabbits were exposed to a test item concentration of 100%. Eyes were unrinsed after treatment and the scored were 0 on days 1, 2 and 3 respectively. Based on these results, magnesium stearate was determined to be not irritating for eyes.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

SKIN IRRITATION/CORROSION:

Weight of Evidence Approach (see rationale attached in IUCLID5 Section 13):

As reported in the Cosmetic Ingredient Review Panel (1982), a skin irritation test was performed on ammonium stearate at a concentration of 100% on rabbits. Test material was applied in a single dose under occlusive conditions. The primary irritation index (P.I.I.) was determined to be 0.62. The substance was non-irritant for skin.

Two studies were performed by Andersen FA (1998) in guinea pigs with topical applications of 0.1 mL of 12% Ammonium Lactate lotion, pH 5.0-5.5. The animals were exposed to UVA light 15-20 min after dosing and the animals were examined after 24 h. In both studies, Ammonium Lactate lotion did not produce erythema at either the irradiated or non-irradiated sites.

A skin irritation test was performed on palmitic acid as commercially supplied (Cosmetic Ingredient Review Panel, 1987). Rabbits were exposed to a single insult occlusive patch of 0.5 ml palmitic acid for 24 hours. The primary irritation index (P.I.I.) was determined to be 0.0 and therefore, the test item palmitic acid was determined to be non-irritant for skin.

According to Cosmetic Ingredient Review Panel (1987), a skin irritation test was performed on stearic acid as commercially supplied. Rabbits were exposed to a single insult occlusive patch of 0.5 ml stearic acid for 24 hours. The primary irritation index (P.I.I.) was determined to be 0.0 and therefore, the test item stearic acid was determined to be non-irritant for skin.

According to Cosmetic Ingredient Review Panel (1987), a skin irritation test was performed on stearic acid as commercially supplied. Rabbits were exposed to a single insult occlusive patch of 0.5 ml stearic acid for 2 hours. The primary irritation index (P.I.I.) was determined to be 0.33 and therefore, the test item stearic acid was determined to be non-irritant for skin.

A skin irritation test was performed on sodium stearate at a concentration of 100% on rabbits (Cosmetic Ingredient Review Panel, 1987). The material was applied in a single dose under occlusive conditions. The primary irritation index (P.I.I.) was determined to be 0.0. The substance was determined to be non-irritant for skin.

A skin irritation test was performed on magnesium stearate at a concentration of 100% on rabbits (Cosmetic Ingredient Review Panel, 1987). The material was applied in a single dose under occlusive conditions for 24 hours. The primary irritation index (P.I.I.) was determined to be 0.0. The substance was determined to be non-irritant for skin.

Taking into account the available experimental results, the weight of evidence approach was applied and the substance Fatty acids, C16 -18 (even numbered), ammonium salts was determined to be non-irritant to the skin since all the results were negative.

EYE IRRITATION:

Weight of Evidence Approach (see rationale attached in IUCLID5 Section 13):

As reported by Cosmetic Ingredient Review Panel, 1982), an Eye Irritation test according to Draize Method was performed on Ammonium stearate. Rabbits were exposed to a test item concentration of 100%. Eyes were rinsed after treatment and the scored were 3, 1 and 0 on days 1, 2 and 3 respectively. Based on these results, ammonium stearate was determined to be not irritating for eyes.

An Eye Irritation test according to Draize Method was performed on Palmitic acid (Cosmetic Ingredient Review Panel, 1987). Rabbits were exposed to a single installation of 0.1 ml of test item as commercially supplied. Both eyes were observed for 72 hours. Palmitic acid was determined to be non-irritant to the eye.

An Eye Irritation test according to Draize Method was performed on Stearic acid (Cosmetic Ingredient Review Panel, 1987). Rabbits were exposed to a single installation of 0.1 ml of test item as commercially suplied. Both eyes were observed for 72 hours. Palmitic acid was determined to be non-irritant to the eye.

An Eye Irritation test according to Draize Method was performed on Sodium stearate. Rabbits were exposed to a test item concentration of 100%. On day one, 2/6 conjunctivae appeared necrotic. Scores were 22, 12, 3, 1 and 1 on days 1, 2, 3, 4 and 7 respectively. According to the Cosmetic Ingredient Review Panel (1982), the eye irritation was considered to be negligible.

Taking into account the available experimental results, the weight of evidence approach was applied and the substance Fatty acids, C16 -18 (even numbered), ammonium salts was determined to be non-irritant to the eye.

Justification for selection of skin irritation / corrosion endpoint:

No study was selected since all studies were not irritating (weight of evidence approach).

Justification for selection of eye irritation endpoint:

No study was selected since all studies were not irritating (weight of evidence approach).

Justification for classification or non-classification

Skin irritation/corrosion: Based on the available data, the substance is not classified according to CLP Regulation (EC) No 1272/2008.

Eye irritation: Based on the available data, the substance is not classified according to CLP Regulation (EC) No 1272/2008.