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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute oral toxicity: Based on experimental results on the analogue substances, the weight of evidence approach was applied and the LD50 for the substance Fatty acids, C16-18 (even numbered), ammonium salts was determined to be >2000 mg/kg bw for acute oral toxicity in rats.

Acute dermal toxicity: Based on experimental results on the analogue substances, the weight of evidence approach was applied and the LD50 for the substance Fatty acids, C16-18 (even numbered), ammonium salts was determined to be >2000 mg/kg bw for acute dermal toxicity in rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
0 (control), 2000 mg/L
No. of animals per sex per dose:
5 animals per sex and per dose.
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred of either males or females in the treated groups.
Clinical signs:
No effects were found on general condition.
Body weight:
No effects were found on body weight changes.
Gross pathology:
No effects were found on autopsy findings.
Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 of docosanoic acid in rats after a single oral dose was >2000 mg/kg bw.
Executive summary:

An acute oral toxicity test was performed on docosanoic acid according to OECD Guideline 401. 5 rats per sex and per dose were exposed to 0 (control) and 2000 mg/kg bw test item by a single gavage route. No deaths occurred of either males or females in the treated groups. No effects were found on general condition, body weight changes or autopsy findings. The LD50 was determined to be >2000 mg/kg bw both for males and females.

Endpoint:
acute toxicity: oral
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 data on GLP.
Principles of method if other than guideline:
Test method not available.
GLP compliance:
not specified
Test type:
other: Acute oral Toxicity
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Concentration of the test substance: 100%.
Key result
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

The LD50 for acute oral toxicity of ammonium stearate was determined to be > 5000 mg/kg bw in rats.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for acute oral toxicity of ammonium stearate was determined to be > 5000 mg/kg bw in male rats.
Executive summary:

The LD50 for acute oral toxicity of ammonium stearate was determined to be > 5000 mg/kg bw in male rats.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
(no data on control)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-6 weeks old
- Fasting period before study: 16 hours
- Acclimation period: At least, 5 days.
Route of administration:
oral: unspecified
Vehicle:
water
Doses:
20, 200, and 2000 mg/kg bw
No. of animals per sex per dose:
Three animals per sex and per dose.
Control animals:
not specified
Details on study design:
Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days.
Necropsy of all animals was carried out at the end of the test.
Animal experiments were performed simultaneously in two different laboratories.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Clinical signs:
No clinical symptoms are reported.

The LD50 for Ammonium sulfate was equal or greater than 2000 mg/kg bw in male and female rats.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for Ammonium sulfate was greater than 2000 mg/kg bw in male and female rats.
Executive summary:

An acute oral toxicity test was performed on ammonium sulfate with a similar method to OECD guideline 423. Three Wistar rats per sex and per dose were orally exposed to 20, 200 and 2000 mg/kg bw test item. The effects were observed for 14 days and at termination animals were necropsied. The LD50 value of greater 2000 mg/kg bw was reported for male and female rats. No adverse effects were reported.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
(no data on control)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no
Species:
mouse
Strain:
other: ddy
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-6 weeks old
- Fasting period before study: 16 hours
- Acclimation period: At least, 5 days.
Route of administration:
oral: unspecified
Vehicle:
water
Doses:
20, 200, and 2000 mg/kg bw
No. of animals per sex per dose:
Three animals per sex and per dose.
Control animals:
not specified
Details on study design:
Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days.
Necropsy of all animals was carried out at the end of the test.
Animal experiments were performed simultaneously in two different laboratories.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Clinical signs:
No clinical symptoms are reported.

The LD50 for Ammonium sulfate was greater than 2000 mg/kg bw in male and female mice.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for Ammonium sulfate was greater than 2000 mg/kg bw in male and female mice.
Executive summary:

An acute oral toxicity test was performed on ammonium sulfate with a similar method to OECD guideline 423. Three mice per sex and per dose were orally exposed to 20, 200 and 2000 mg/kg bw test item. The effects were observed for 14 days and at termination animals were necropsied. The LD50 value of greater 2000 mg/kg bw was reported for male and female mice. No adverse effects were reported.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(no data on control)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no
Species:
mouse
Strain:
other: ddy
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-6 weeks old
- Fasting period before study: 16 hours
- Acclimation period: At least, 5 days.
Route of administration:
oral: unspecified
Vehicle:
water
Doses:
20, 200, and 2000 mg/kg bw
No. of animals per sex per dose:
Three animals per sex and per dose.
Control animals:
not specified
Details on study design:
Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days.
Necropsy of all animals was carried out at the end of the test.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 040 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 670 - <= 3 440
Clinical signs:
No clinical symptoms are reported.

The LD50 for Ammonium sulfate was estimated to be 3040 mg/kg bw in male and female mice.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for Ammonium sulfate was 3040 mg/kg bw in male and female mice.
Executive summary:

An acute oral toxicity test was performed on ammonium sulfate according to the Toxicity Guidelines of Japan (1984). Three mice per sex and per dose were orally exposed to 20, 200 and 2000 mg/kg bw test item. The effects were observed for 14 days and at termination animals were necropsied. The LD50 value was determined to be 3040 mg/kg bw for male and female mice. No adverse effects were reported.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
No data on test method.
GLP compliance:
not specified
Test type:
other: no data
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 600 mg/kg bw

The LD50 for stearic acid was 4600 mg/kg bw in rats.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for stearic acid was 4600 mg/kg bw in rats.
Executive summary:

The LD50 for stearic acid was 4600 mg/kg bw in rats.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
No data on test method.
GLP compliance:
not specified
Test type:
other: no data
Species:
other: Human
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD100
Effect level:
14 286 mg/kg bw

The LD100 for stearic acid was 14286 mg/kg bw in humans.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD100 for stearic acid was 14286 mg/kg bw in humans
Executive summary:

The LD100 for stearic acid was 14286 mg/kg bw in humans

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
Scientific Panel Review Article. No data on GLP. Only males were tested and no data was reported on controls.
Principles of method if other than guideline:
- Principle of test: An acute oral toxicity test was performed on stearic acid. Doses up to 10.0 g/kg of stearic acid as commercially supplied were administered by gavage to 5 male albino rats per dose. No details on study design was reported.
GLP compliance:
not specified
Test type:
other: Acute oral Toxicity
Limit test:
no
Species:
rat
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 216-225 g
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
25% of stearic acid (w/v) in corn oil.
Doses:
464, 1000, 2150, 4640, 10000 mg/kg bw.
No. of animals per sex per dose:
5 male rats per dose.
Control animals:
not specified
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
One death in 10000 mg/kg bw on day 7 of study.
Clinical signs:
Transient signs of toxicity were observe in rats of the higher dose groups. Signs of toxicity included slight depression, depressed righting and placement reflexes, oily and unkempt fur, mucoid diarrhea, excessive salivation, and serosanguineous discharge from the muzzle and eyes.
Body weight:
Range, avg. BW gain: 90-104 g at lower doses and 77 g at 10000 mg/kg bw dose.
Gross pathology:
At necropsy of the rat which was dead on day 7 at 10000 mg/kg bw dose, congested lungs and kidneys and advanced autolytic changes were observed.

The LD50 for acute oral toxicity of stearic acid was determined to be > 10000 mg/kg bw in male rats.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for acute oral toxicity of stearic acid was determined to be > 10000 mg/kg bw in male rats.
Executive summary:

An acute oral toxicity test was performed on male albino rats. Test item stearic acid (25% corn oil) was administered by gavage at 464, 1000, 2150, 4640, 10000 mg/kg bw to five animals per dose. Transient signs of toxicity were observed in rats of the higher dose group. One death occurred in the 10000 mg/kg bw group on day 7 of study. At necropsy of this rat congested lungs and kidneys and advanced autolytic changes were observed. The LD50 for acute oral toxicity of stearic acid was determined to be > 10000 mg/kg bw in male rats.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
Scientific Panel Review Article. No data on GLP. Only males were tested and no data was reported on controls.
Principles of method if other than guideline:
-Principle of test: An acute oral toxicity test was performed on palmitic acid. Doses up to 10.0 g/kg of palmitic acid as commercially supplied were administered by gavage to 5 male albino rats per dose. No details on study design was reported.
GLP compliance:
not specified
Test type:
other: Acute oral Toxicity
Limit test:
no
Species:
rat
Strain:
other: albino
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 209-254 g
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The substance was administered as commercially supplied.
Doses:
464, 1000, 2150, 4640, 10000 mg/kg bw.
No. of animals per sex per dose:
5 male rats per dose.
Control animals:
not specified
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Transient signs of toxicity were observe in rats of 4640 and 10000 mg/kg bw dose groups. Signs of toxicity included slight depression, depressed righting and placement reflexes, oily and unkempt fur, mucoid diarrhea, excessive salivation, and serosanguineous discharge from the muzzle and eyes.
Body weight:
Range, avg. BW gain: 62-92 g.

The LD50 for acute oral toxicity of palmitic acid was determined to be > 10000 mg/kg bw in male rats.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for acute oral toxicity of palmitic acid was determined to be > 10000 mg/kg bw in male rats.
Executive summary:

An acute oral toxicity test was performed on male albino rats. Test item palmitic acid (as commercially supplied) was administered by gavage at 464, 1000, 2150, 4640, 10000 mg/kg bw to fine animals per dose. Transient signs of toxicity were observed in rats of 4640 and 10000 mg/kg bw dose groups. No deaths occurred at any dose group. The LD50 for acute oral toxicity of palmitic acid was determined to be > 10000 mg/kg bw in male rats.

Endpoint:
acute toxicity: oral
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 data on GLP.
Principles of method if other than guideline:
-principle of test: An acute toxicity test was performed on sodium stearate. Test item was administered at a dose of 5 g/kg to 6 rats. Clinical signs and necropsy were performed. No details on study design was reported.
GLP compliance:
not specified
Test type:
other: Acute oral Toxicity
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
propylene glycol
Details on oral exposure:
Concentration of the test substance: 25% in propylenen glycol.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
6 rats per dose
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Clinical signs:
There were no remarkable clinical findings.
Gross pathology:
There were no remarkable necropsy findings.

The LD50 for acute oral toxicity of sodium stearate was determined to be > 50000 mg/kg bw in rats.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for acute oral toxicity of sodium stearate was determined to be > 50000 mg/kg bw in rats.
Executive summary:

An acute toxicity test was performed on test item sodium stearate. Six rats were exposed to a single dose of sodium stearate (25% in propylene glycol) by oral route at a dose of 5 mg/kg bw. There were no remarkable clinical or necropsy findings. The LD50 for oral acute toxicity for sodium stearate was determined to be > 5000 mg/kg in rats.

Endpoint:
acute toxicity: oral
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 data on GLP.
Principles of method if other than guideline:
-Principle of test: Albino rats were given orally doses ranging from 0.05 to 10.0 g/kg magnesium stearate (25% in corn oil). Animals were observed for 14 days. Test method according to Hagan; Litchfield and Wilcoxon.
GLP compliance:
not specified
Test type:
other: Acute oral Toxicity
Limit test:
yes
Species:
rat
Strain:
other: albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: Animas were fasted overnight
Route of administration:
oral: unspecified
Vehicle:
corn oil
Details on oral exposure:
Concentration of the test substance: 25% in corn oil.
Doses:
Doses ranging from 50 to 10000 mg/kg bw.
No. of animals per sex per dose:
No data.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Clinical signs:
All animals at 10000 mg/kg bw exhibited mild diarrhea.

The LD50 for acute oral toxicity of magnesium stearate was determined to be > 10000 mg/kg bw in rats.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for acute oral toxicity of magnesium stearate was determined to be > 10000 mg/kg bw in rats.
Executive summary:

An acute toxicity test was performed on test item magnesium stearate. Albino rats were given orally doses ranging from 0.05 to 10.0 g/kg magnesium stearate (25% in corn oil). Animals were observed for 14 days. All animals at 10000 mg/kg bw exhibited mild diarrhea. The LD50 for oral acute toxicity of magnesium stearate was determined to be > 10000 mg/kg in rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 001 mg/kg bw
Quality of whole database:
Several studies were available on rat and mice, plus one in human. The klimisch scores were between K1 and K4. A weight of evidence approach was applied and the overall quality of the database was determined as appropriate for assessment.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. The information is provided for dermal route.
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Toxicity Guidelines of Japan (Ministry of Health and Welfare in Japan, 1984)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-6 weeks old
- Housing: All animals were individually housed in stainless-steel cages.
- Acclimation period: At least, 5 days.
Type of coverage:
open
Vehicle:
other: water-acetone solution
Details on dermal exposure:
In the dermal toxicity test, hair was first removed from an area of 3 x 4 cm2 on the back of animals with an electric hair clipper, and then the chemical substance was dissolved in acetone and water and applied in a single dose to the skin surface of the clipped backs of the animals. The application sites were not covered but the treated areas were prevented from being licked by using a plastic collar or by fixing the animals on a plastic plate, and all animals were individually housed in stainless-steel cages.
Duration of exposure:
A single administration, but no data on removing.
Doses:
20, 200, and 2000 mg/kg bw.
No. of animals per sex per dose:
Three animals per sex and per dose.
Control animals:
not specified
Details on study design:
Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days.
Necropsy of all animals was carried out at the end of the test.
Animal experiments were performed simultaneously in two different laboratories.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Clinical signs:
No treatment-related clinical signs were observed.
Gross pathology:
No effects were observed at necropsy.

The LD50 was higher than 2000 mg/kg bw for rats after dermal application of ammonium sulfate.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 was greater than 2000 mg/kg bw for rats after dermal application of ammonium sulfate.
Executive summary:

An acute dermal toxicity test was performed on ammonium sulfate in accordance Toxicity Guidelines of Japan (Ministry of Health and Welfare in Japan, 1984). Three Wistar rats per sex and per dose were exposed to 20, 200, and 2000 mg/kg bw of test item. The chemical substance was dissolved in acetone and water and applied in a single dose to the skin surface of the clipped backs of the animals. The application sites were not covered but the treated areas were prevented from being licked by using a plastic collar or by fixing the animals on a plastic plate. No treatment-related clinical signs and necropsy findings were observed. The LD50 values higher than 2000 mg/kg bw are reported for rats after dermal application of ammonium sulfate.

Endpoint:
acute toxicity: dermal
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 data on GLP.
Principles of method if other than guideline:
-Principle of test: An acute dermal toxicity test was performed with ammonium stearate at 100% concentration on Guinea Pigs. Dermal contact with the test material was maintained for 24 hours. No details were reported on study design.
GLP compliance:
not specified
Test type:
other: Acute dermal toxicity test
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Test item concentration: 100%
Duration of exposure:
24 hours.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.

The acute dermal toxicity study on Guinea Pigs with ammonium stearate (100%) showed a LD50 of > 3000 mg/kg.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The acute dermal toxicity study on Guinea Pigs with ammonium stearate (100%) showed a LD50 of > 3000 mg/kg.
Executive summary:

An acute dermal toxicity test was performed with ammonium stearate at 100% concentration on Guinea Pigs. Dermal contact with the test material was maintained for 24 hours. The LD50 was determined to be > 3000 mg/kg.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Toxicity Guidelines of Japan (Ministry of Health and Welfare in Japan, 1984)
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
no
Species:
mouse
Strain:
other: ddy
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-6 weeks old
- Housing: All animals were individually housed in stainless-steel cages.
- Acclimation period: At least, 5 days.
Type of coverage:
open
Vehicle:
other: water-acetone solution
Details on dermal exposure:
In the dermal toxicity test, hair was first removed from an area of 1 x 2 cm2 on the back of animals with an electric hair clipper, and then the chemical substance was dissolved in acetone and water and applied in a single dose to the skin surface of the clipped backs of the animals. The application sites were not covered but the treated areas were prevented from being licked by using a plastic collar or by fixing the animals on a plastic plate, and all animals were individually housed in stainless-steel cages.
Duration of exposure:
A single administration, but no data on removing.
Doses:
20, 200, and 2000 mg/kg bw.
No. of animals per sex per dose:
Three animals per sex and per dose.
Control animals:
not specified
Details on study design:
Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days.
Necropsy of all animals was carried out at the end of the test.
Animal experiments were performed simultaneously in two different laboratories.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Clinical signs:
No treatment-related clinical signs findings were observed.
Gross pathology:
No treatment-related necropsy findings were observed.

The LD50 was higher than 2000 mg/kg bw for mice after dermal application of ammonium sulfate.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 was greater than 2000 mg/kg bw for mice after dermal application of ammonium sulfate.
Executive summary:

An acute dermal toxicity test was performed on ammonium sulfate in accordance Toxicity Guidelines of Japan (Ministry of Health and Welfare in Japan, 1984). Three mice per sex and per dose were exposed to 20, 200, and 2000 mg/kg bw of test item. The chemical substance was dissolved in acetone and water and applied in a single dose to the skin surface of the clipped backs of the animals. The application sites were not covered but the treated areas were prevented from being licked by using a plastic collar or by fixing the animals on a plastic plate. No treatment-related clinical signs and necropsy findings were observed. The LD50 values higher than 2000 mg/kg bw are reported for mice after dermal application of ammonium sulfate.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
Test method not available
GLP compliance:
not specified
Test type:
other: acute dermal toxicity
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Control animals:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

The LD50 for acute dermal toxicity of stearic acid was >5000 mg/kg bw in rabbits.

Interpretation of results:
other: Not classified (CLP Regulation EC no. 1272/2008)
Conclusions:
The LD50 for acute dermal toxicity of stearic acid was >5000 mg/kg bw in rabbits.
Executive summary:

The LD50 for acute dermal toxicity of stearic acid was >5000 mg/kg bw in rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 001 mg/kg bw
Quality of whole database:
Four studies were available. The studies were performed on guinea pigs (klimisch 3), rats (klimisch 2), mice (klimish 2) and rabbits (klimisch 4). A weight of evidence approach was applied and the overall quality of the database was determined as appropriate for assessment.

Additional information

ACUTE ORAL TOXICITY:

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

According to the Cosmetic Ingredient Review Panel (1982), the LD50 for acute oral toxicity of ammonium stearate was determined to be > 5000 mg/kg bw in male rats.

Two acute oral toxicity study were performed by Yamanaka S et al. (1990) on ammonium sulfate with a similar method to OECD guideline 423 in rats and mice up to 2000 mg/kg bw. The LD50 was determined to be greater than 2000 mg/kg bw for both rats (male and females) and mice (male and female). No adverse effects were reported.

In the same publication by Yamana S et al. (1990), an acute oral toxicity test was reported on ammonium sulfate according to the Toxicity Guidelines of Japan (1984). Mice were orally exposed up to 2000 mg/kg bw test item. The LD50 value was determined to be 3040 mg/kg bw for male and female mice. No adverse effects were reported.

An acute oral toxicity test was performed on docosanoic acid according to OECD Guideline 401 by the Ministry of Health, Labour and Welfare, Japan (1998). Rats were exposed to 2000 mg/kg bw test item by a single gavage route. No effects were found and therefore, the LD50 was determined to be >2000 mg/kg bw both for males and females.

In accordance with Clayton GD et al. (1994) the LD50 for stearic acid was determined to be 4600 mg/kg bw in rats.

In a publication by Gosselin RE et al. (1976) the LD100 for stearic acid was reported to be 14286 mg/kg bw in humans.

According to the Cosmetic Ingredient Review Panel (1987), an acute toxicity test was performed on stearic acid as commercially supplied (25% in corn oil) up to 10 g/kg. The LD50 was determined to be > 10000 mg/kg bw in male rats.

As reported the Cosmetic Ingredient Review Panel (1987), an acute toxicity test was performed on palmitic acid as commercially supplied up to 10 g/kg. The LD50 was determined to be > 10000 mg/kg bw in male rats.

An acute toxicity test was performed on test item sodium stearate (Cosmetic Ingredient Review Panel, 1982). Rats were exposed to a single dose of sodium stearate (25% in propylene glycol) by oral route at a dose of 5 mg/kg bw. Since no remarkable clinical or necropsy findings were observed, the LD50 was determined to be > 5000 mg/kg.

In accordance with the Cosmetic Ingredient Review Panel (1982), an acute toxicity test was performed on test item magnesium stearate. Rats were given orally doses ranging up to 10.0 g/kg magnesium stearate (25% in corn oil). The LD50 was determined to be > 10000 mg/kg.

Taking into account the available experimental results, the weight of evidence approach was applied and the LD50 for acute oral toxicity for the substance Fatty acids, C16 -18 (even numbered), ammonium salts was determined to be >2000 mg/kg bw in rats (based on the worst case assumption).

ACUTE DERMAL TOXICITY:

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

As reported by the Cosmetic Ingredient Review Panel (1982), an acute dermal toxicity test was performed with ammonium stearate at 100% concentration on Guinea Pigs . Dermal contact with the test material was maintained for 24 hours. The LD50 was determined to be > 3000 mg/kg.

An acute dermal toxicity test was performed on ammonium sulfate in accordance Toxicity Guidelines of Japan (Ministry of Health and Welfare in Japan, 1984) by Yamanaka S et al. (1990). Rats were dermally exposed up to 2000 mg/kg bw of test item. No treatment-related clinical signs and necropsy findings were observed and therefore, the LD50 was determined to be higher than 2000 mg/kg bw in rats.

The same acute dermal toxicity test by Yamanaka S et al (1990) was performed on ammonium sulfate in mouse according to Toxicity Guidelines of Japan (Ministry of Health and Welfare in Japan, 1984). Mice were exposed up to 2000 mg/kg bw of test item by dermal application. No treatment-related clinical signs and necropsy findings were observed and therefore, the LD50 was determined to be higher than 2000 mg/kg bw in mice.

According to Clayton GD et al. (1982), the LD50 for acute dermal toxicity of stearic acid was reported to be >5000 mg/kg bw in rabbits.

Taking into account the available experimental results, the weight of evidence approach was applied and the LD50 for acute dermal toxicity for the substance Fatty acids, C16 -18 (even numbered), ammonium salts was determined to be >2000 mg/kg bw in rats (based on the worst case assumption and the study perfomed on rats.).

Justification for selection of acute toxicity – oral endpoint

The lowest LD50 was chosen based on the worst case assumption.

Justification for selection of acute toxicity – inhalation endpoint

According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided. The information is provided for dermal route.

Justification for selection of acute toxicity – dermal endpoint

The lowest LD50 was chosen based on the worst case assumption, within the studies performed in rats.

Justification for classification or non-classification

Based on the available data on oral and dermal acute toxicity (LD50 > 2000 mg/kg bw), the substance Fatty acids, C16 -18 (even numbered), ammonium salts is not classified for acute toxicity in accordance with CLP Regulation (EC) No 1272/2008.