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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

LD50 was considered to be > 5000 mg/kg bw when rats were treated with aluminum trioctadecanoate orally.

Acute dermal toxicity:

LD50 was considered to be > 3000 mg/kg bw when Guinea pigs were treated with aluminum trioctadecanoate orally.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer-reviewed journal
Qualifier:
according to guideline
Guideline:
other: No data
Principles of method if other than guideline:
Acute oral toxicity study of Aluminum Stearate in rats
GLP compliance:
not specified
Test type:
other: No data
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report):Aluminum Stearate- Molecular formula (if other than submission substance):C18H36O2.1/3Al- Molecular weight (if other than submission substance):877.3995 g/mole- Substance type:Organic- Physical state:Solid
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
When treated with 5000 mg/kg bw, No mortality were observed in treated rats.
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be > 5000 mg/kg bw when rats were treated with Aluminum tristearate orally.
Executive summary:

In a acute roal toxicity study, rat were treated with aluminum trioctadecanoate in the concentration of 5000 mg/kg bw orally. No mortality were observed in treated rats at 5000 mg/kg bw when rats were treated with aluminum trioctadecanoate orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer- reviewed journal

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer-reviewed journal
Qualifier:
according to guideline
Guideline:
other: No data
Principles of method if other than guideline:
Acute dermal toxicity study of Aluminum Stearate in guinea pigs
GLP compliance:
not specified
Test type:
other: No data
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report):Aluminum Stearate (Aluminum tristearate )- Molecular formula (if other than submission substance):C18H36O2.1/3Al- Molecular weight (if other than submission substance):877.3995 g/mole- Substance type:Organic- Physical state:Solid (powder)
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data available
Duration of exposure:
24 hrs
Doses:
3000 mg/kg bw
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
Dermal contact with the test material was maintained for 24 hrs.
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
When treated with 3000 mg/kg bw, No mortality were observed in treated Guinea pigs at 3000 mg/kg bw.
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be > 3000 mg/kg bw when Guinea pigs were treated with aluminum trioctadecanoate orally.
Executive summary:

In a acute dermal toxicity study, Guinea pigs were treated with aluminum trioctadecanoate in the concentration of 3000 mg/kg bw dermally. No mortality were observed in treated Guinea pigs at 3000 mg/kg bw. Therefore, LD50 was considered to be > 3000 mg/kg bw when Guinea pigs were treated with aluminum trioctadecanoate orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer- reviewed journal

Additional information

Acute oral toxicity:

In different studies, aluminum trioctadecanoate has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments in rodents, i.e. most commonly in rats for aluminum trioctadecanoate along with the study available on structurally similar read across substance zinc distearate (CAS no 557-05-1).

In a study conducted by American College of Toxicology (International Journal of Toxicology, 1982, vol. 1, no. 2, page-143-177), acute oral toxicity was evaluated in rats by using aluminum trioctadecanoate in the concentration of 5000 mg/kg bw orally. No mortality was observed in treated rats at 5000 mg/kg bw. Therefore, LD50 was considered to be > 5000 mg/kg bw when rats were treated with aluminum trioctadecanoate orally.

In another supporting study conducted by Sustainability Support Services (Europe) AB (2014) on structurally similar read across substance zinc distearate (CAS no 557-05-1) as per OECD No. 423, Six female Wistar rats by using Zinc distearate. Rat were fasted for 16 to 18 hours, prior to dosing (water was given ad libitum). After test item administration, feed was withheld for a further 4 hours. The time interval between dosing was determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed. At 2000 mg/kg, all the six animals were observed with normal clinical sign till day 14. No mortality was observed throughout the experimentation period. Mean body weight of animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0 .No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. The acute oral LD50 (cut-off value) of Zinc distearate was 5000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Zinc distearate does not exhibit acute oral toxicity i.e it is acutely non toxic to animals.

Also it is further supported experimental data conducted by American College of Toxicology (Journal of the American College of Toxicology. Vol. 1, no. 2 (1982). p. 143-177) for above similar read across, Albino rats were treated with zinc distearate in the concentration of 10000 mg/kg bw orally as a 25% suspension in corn oil and 5000 mg/kg bw as a 100%. No mortality was observed in treated rats at 10000 mg/kg bw and 5000 mg/kg bw . Therefore, LD50 was considered to be >5000 and 10000 mg/kg bw when Albino rats were treated with zinc distearate orally.

Thus, based on the above studies and predictions on aluminum trioctadecanoate and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, aluminum trioctadecanoate can be “Not classified” for acute oral toxicity.

Acute dermal toxicity:

In different studies, aluminum trioctadecanoate has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments in rodents, i.e. most commonly in Guinea pigs and rabbit for aluminum trioctadecanoate along with the study available on structurally similar read across substance zinc distearate (CAS no 557-05-1). 

In a study conducted by American College of Toxicology (International Journal of Toxicology, 1982, vol. 1, no. 2, page-143-177), Guinea pigs were treated with aluminum trioctadecanoate in the concentration of 3000 mg/kg bw dermally. No mortality were observed in treated Guinea pigs at 3000 mg/kg bw. Therefore, LD50 was considered to be > 3000 mg/kg bw when Guinea pigs were treated with aluminum trioctadecanoate orally.

In a above similar source acute dermal toxicity was evaluated on structurally similar read across substance zinc distearate (CAS no 557-05-1) by using rabbit in the concentration of 2000 mg/kg bw as a 10% applied dermally. No mortality was observed in treated rabbits at 2000 mg/kg bw. Therefore, LD50 was considered to be > 2000 mg/kg bw when rabbits were treated with zinc distearate dermally.

Thus, based on the above studies and predictions on aluminum trioctadecanoate and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, aluminum trioctadecanoate can be “Not classified” for acute dermal toxicity.

Justification for classification or non-classification

Based on the above studies and predictions on aluminum trioctadecanoate and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, aluminum trioctadecanoate can be “Not classified” for acute oral and dermal toxicity.