Registration Dossier

Administrative data

Description of key information

No information was available on the test substance, therefore read across was used to fill the endpoint. One key study is available for the acute oral toxicity endpoint on medium- and long-chain triacylglycerol. This study was considered to be of robust design and well reported and assigned a Klimisch score of 2. Four other supporting studies were also available with Klimisch scores of 4, all with no adverse effects observed. The supporting studies were conducted on stearic acid, palmitic acid, oleic acid, linoleic acid and glyceryl stearate.

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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Not specified.
Statistics:
Not specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Practically non-toxic.
Clinical signs:
Practically non-toxic.
Body weight:
Practically non-toxic.
Gross pathology:
Practically non-toxic.
Conclusions:
The LD50 for rats was >5000 mg/kg body weight for glyceryl stearate.
Executive summary:

Rats were used for this study. The test substance, glyceryl stearate, was administered via oral gavage at a dose of 5000 mg/kg to groups of 5 rats. Due to a lack of toxic effects, and the test material being practically non-toxic, the LD50 of glyceryl stearate was determined to be >5000 mg/kg body weight.

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
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Nisshin Oillo Group, Ltd., Tokyo, Japan
- Composition: Caprylic acid (9.7%), capric acid (3.3%), palmitic acid (3.8%), stearic acid (1.7%), oleic acid (51.2%), linoleic acid (18.4%), linolenic acid (9.0%) and other fatty acids (2.9%)
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC Co., Ltd., Hamamatsu, Japan
- Age at study initiation: 5 weeks old
Route of administration:
oral: gavage
Vehicle:
other: Mixed rapeseed and soybean oils (7:3)
Doses:
0 and 5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 1, 2, 3, 4, 7 and 14
- Necropsy: Yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
All animals administered MLCT at 5000 mg/kg survived.
Clinical signs:
There were no abnormal clinical signs.
Body weight:
All animals administered MLCT at 5000 mg/kg showed typical body weight gain throughout the observation period.
Gross pathology:
There were no abnormal gross pathological abnormalities in any organ/tissue.
Conclusions:
In conclusion, MLCT showed no significant acute toxic effects, therefore the LD50 was in excess of 5000 mg/kg.
Executive summary:

Twenty Wistar rats, 10 males and 10 females. approximately 5 weeks old, were obtained from Japan SLC Co., Ltd. for this study. The rats were divided into two groups, a control group and a treatment group, each containing 5 males and 5 females. The test substance, MLCT, was administered via oral gavage at doses of 0 (control) and 5000 mg/kg. The vehicle used was mixed rapeseed and soybean oils (7:3), and control animals were dosed with the vehicle alone. Rats were observed for 6 hours after administration, and once a day for 14 days following treatment. Body weights were measured on test days 0, 1, 2, 3, 4, 7 and 14, and animals surviving until test day 14 were sacrificed and necropsied. All rats treated with 5000 mg/kg survived, showed no abnormal clinical signs and showed typical body weight gain throughout the observation period. There were no gross pathological abnormalities observed in any tissue or organ during necropsy. Therefore, due to a lack of acute toxic effects, the LD50 was determined to be > 5000 mg/kg.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Composition:
C14 = 0.3%; C16 = 13.0%; C18 = 4.1%; C18:1 = 23.3%; C18:2 = 53.0%; C18:3 = 6.2%
Species:
rat
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
None specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None specified.
Doses:
21.5 ml/kg
No. of animals per sex per dose:
Not specified.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 21.5 mL/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Not specified.
Clinical signs:
Not specified.
Body weight:
The animals demonstrated a weight gain of at least 30% over original body weight during the 14-day test period.
Gross pathology:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
The LD50 for male albino rats was > 21.5 ml/kg body weight for linoleic acid.
Executive summary:

Albino rats were used for this study. The test substance, linoleic acid, was administered via oral gavage at a dose of 21.5 ml/kg, and the animals were the observed for 14 days. Due to a lack of toxic effects during the 14 -day test period, the LD50 of linoleic acid was determined to be >21.5 ml/kg body weight.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Composition:
C12 = 0.4%; C14 = 2.7%; C14:1 = 1.0% C16 = 4.5%; C16:1 = 6.2%; C17 = 1.2%; C18 = 1.6%; C18:1 = 74.7%; C18:2 = 7.4%; C18:3 = 0.4%
Species:
rat
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
None specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None specified.
Doses:
21.5 ml/kg
No. of animals per sex per dose:
Not specified.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 21.5 mL/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Not specified.
Clinical signs:
Not specified.
Body weight:
The animals demonstrated a weight gain of at least 30% over original body weight during the 14-day test period.
Gross pathology:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
The LD50 for male albino rats was > 21.5 ml/kg body weight for oleic acid.
Executive summary:

Albino rats were used for this study. The test substance, oleic acid, was administered via oral gavage at a dose of 21.5 ml/kg, and the animals were the observed for 14 days. Due to a lack of toxic effects during the 14 -day test period, the LD50 of oleic acid was determined to be >21.5 ml/kg body weight.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Composition:
C14 = 2.0%; C16 = 95%; C18 = 3.0%
Species:
rat
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
None specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None specified.
Doses:
10 mg/kg
No. of animals per sex per dose:
Not specified.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Not specified.
Clinical signs:
Not specified.
Body weight:
The animals demonstrated a weight gain of at least 30% over original body weight during the 14-day test period.
Gross pathology:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
The LD50 for male albino rats was > 10 mg/kg body weight for palmitic acid.
Executive summary:

Albino rats were used for this study. The test substance, palmitic acid, was administered via oral gavage at a dose of 10 mg/kg, and the animals were the observed for 14 days. Due to a lack of toxic effects during the 14 -day test period, the LD50 of palmitic acid was determined to be >10 mg/kg body weight.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across: supporting information
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Composition:
C14 = 0.2%; C16 = 7.7%; C17 = 0.2%; C18 = 91.9%
Species:
rat
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
None specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None specified.
Doses:
10 mg/kg
No. of animals per sex per dose:
Not specified.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Not specified.
Clinical signs:
Not specified.
Body weight:
The animals demonstrated a weight gain of at least 30% over original body weight during the 14-day test period.
Gross pathology:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
The LD50 for male albino rats was > 10 mg/kg body weight for stearic acid.
Executive summary:

Albino rats were used for this study. The test substance, stearic acid, was administered via oral gavage at a dose of 10 mg/kg, and the animals were the observed for 14 days. Due to a lack of toxic effects during the 14 -day test period, the LD50 of stearic acid was determined to be >10 mg/kg body weight.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
Not specified.
Statistics:
Not specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Practically non-toxic.
Clinical signs:
Practically non-toxic.
Body weight:
Practically non-toxic.
Gross pathology:
Practically non-toxic.
Conclusions:
The LD50 for rats was >5000 mg/kg body weight for glyceryl stearate.
Executive summary:

Rats were used for this study. The test substance, glyceryl stearate, was administered via oral gavage at a dose of 5000 mg/kg to groups of 5 rats. Due to a lack of toxic effects, and the test material being practically non-toxic, the LD50 of glyceryl stearate was determined to be >5000 mg/kg body weight.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Composition:
C14 = 0.3%; C16 = 13.0%; C18 = 4.1%; C18:1 = 23.3%; C18:2 = 53.0%; C18:3 = 6.2%
Species:
rat
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
None specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None specified.
Doses:
21.5 ml/kg
No. of animals per sex per dose:
Not specified.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 21.5 mL/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Not specified.
Clinical signs:
Not specified.
Body weight:
The animals demonstrated a weight gain of at least 30% over original body weight during the 14-day test period.
Gross pathology:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
The LD50 for male albino rats was > 21.5 ml/kg body weight for linoleic acid.
Executive summary:

Albino rats were used for this study. The test substance, linoleic acid, was administered via oral gavage at a dose of 21.5 ml/kg, and the animals were the observed for 14 days. Due to a lack of toxic effects during the 14 -day test period, the LD50 of linoleic acid was determined to be >21.5 ml/kg body weight.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Nisshin Oillo Group, Ltd., Tokyo, Japan
- Composition: Caprylic acid (9.7%), capric acid (3.3%), palmitic acid (3.8%), stearic acid (1.7%), oleic acid (51.2%), linoleic acid (18.4%), linolenic acid (9.0%) and other fatty acids (2.9%)
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC Co., Ltd., Hamamatsu, Japan
- Age at study initiation: 5 weeks old
Route of administration:
oral: gavage
Vehicle:
other: Mixed rapeseed and soybean oils (7:3)
Doses:
0 and 5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 1, 2, 3, 4, 7 and 14
- Necropsy: Yes
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
All animals administered MLCT at 5000 mg/kg survived.
Clinical signs:
There were no abnormal clinical signs.
Body weight:
All animals administered MLCT at 5000 mg/kg showed typical body weight gain throughout the observation period.
Gross pathology:
There were no abnormal gross pathological abnormalities in any organ/tissue.
Conclusions:
In conclusion, MLCT showed no significant acute toxic effects, therefore the LD50 was in excess of 5000 mg/kg.
Executive summary:

Twenty Wistar rats, 10 males and 10 females. approximately 5 weeks old, were obtained from Japan SLC Co., Ltd. for this study. The rats were divided into two groups, a control group and a treatment group, each containing 5 males and 5 females. The test substance, MLCT, was administered via oral gavage at doses of 0 (control) and 5000 mg/kg. The vehicle used was mixed rapeseed and soybean oils (7:3), and control animals were dosed with the vehicle alone. Rats were observed for 6 hours after administration, and once a day for 14 days following treatment. Body weights were measured on test days 0, 1, 2, 3, 4, 7 and 14, and animals surviving until test day 14 were sacrificed and necropsied. All rats treated with 5000 mg/kg survived, showed no abnormal clinical signs and showed typical body weight gain throughout the observation period. There were no gross pathological abnormalities observed in any tissue or organ during necropsy. Therefore, due to a lack of acute toxic effects, the LD50 was determined to be > 5000 mg/kg.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Composition:
C12 = 0.4%; C14 = 2.7%; C14:1 = 1.0% C16 = 4.5%; C16:1 = 6.2%; C17 = 1.2%; C18 = 1.6%; C18:1 = 74.7%; C18:2 = 7.4%; C18:3 = 0.4%
Species:
rat
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
None specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None specified.
Doses:
21.5 ml/kg
No. of animals per sex per dose:
Not specified.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 21.5 mL/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Not specified.
Clinical signs:
Not specified.
Body weight:
The animals demonstrated a weight gain of at least 30% over original body weight during the 14-day test period.
Gross pathology:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
The LD50 for male albino rats was > 21.5 ml/kg body weight for oleic acid.
Executive summary:

Albino rats were used for this study. The test substance, oleic acid, was administered via oral gavage at a dose of 21.5 ml/kg, and the animals were the observed for 14 days. Due to a lack of toxic effects during the 14 -day test period, the LD50 of oleic acid was determined to be >21.5 ml/kg body weight.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Composition:
C14 = 2.0%; C16 = 95%; C18 = 3.0%
Species:
rat
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
None specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None specified.
Doses:
10 mg/kg
No. of animals per sex per dose:
Not specified.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Not specified.
Clinical signs:
Not specified.
Body weight:
The animals demonstrated a weight gain of at least 30% over original body weight during the 14-day test period.
Gross pathology:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
The LD50 for male albino rats was > 10 mg/kg body weight for palmitic acid.
Executive summary:

Albino rats were used for this study. The test substance, palmitic acid, was administered via oral gavage at a dose of 10 mg/kg, and the animals were the observed for 14 days. Due to a lack of toxic effects during the 14 -day test period, the LD50 of palmitic acid was determined to be >10 mg/kg body weight.

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Specific details on test material used for the study:
Composition:
C14 = 0.2%; C16 = 7.7%; C17 = 0.2%; C18 = 91.9%
Species:
rat
Strain:
other: Albino
Sex:
not specified
Details on test animals and environmental conditions:
None specified.
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
None specified.
Doses:
10 mg/kg
No. of animals per sex per dose:
Not specified.
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None specified.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
Not specified.
Clinical signs:
Not specified.
Body weight:
The animals demonstrated a weight gain of at least 30% over original body weight during the 14-day test period.
Gross pathology:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
The LD50 for male albino rats was > 10 mg/kg body weight for stearic acid.
Executive summary:

Albino rats were used for this study. The test substance, stearic acid, was administered via oral gavage at a dose of 10 mg/kg, and the animals were the observed for 14 days. Due to a lack of toxic effects during the 14 -day test period, the LD50 of stearic acid was determined to be >10 mg/kg body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
10 mg/kg bw
Quality of whole database:
One Klimisch 2 study and five Klimisch 4 studies were identified.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

One key study is available for the acute oral toxicity endpoint. This study was considered to be of robust design and well reported and assigned a Klimisch score of 2. Four other supporting studies were also available with Klimisch scores of 4, all with no adverse effects observed. As the acute oral studies resulted in predicted LD50 levels in excess of the 2000 mg/kg limit dose, it was concluded that the test item is not classified for acute toxicity according to the CLP Regulation (EC) No 1272/2008.