Registration Dossier

Administrative data

Description of key information

Acute toxicity studies for read-across substances are available by oral and dermal routes of administration.  The acute inhalation study was not considered necessary and no read -across data were available for this route of exposure. Oral administration of octyl steartae to rats elicited no signs of toxicity up to a dose of 8000 mg/kg bw.   Oral dosing with ethyl hexyl palmitate also resulted in a median lethal dose that exceed the limit of 5 g/kg bw. The dermal toxicity investigated in rabbits for the analogous material, ethylhexyl palmitate, resulted in a median lethal dose that exceeded the 5 g/kg bw limit.

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
Study period:
February 1978
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: A single page summary of the study results is available but insufficient details are present to assess the study reliability accurately
Qualifier:
no guideline followed
Principles of method if other than guideline:
Standard single dose gavage assay
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No information in study report
- Humidity (%):No information in study report
- Air changes (per hr):No information in study report
- Photoperiod (hrs dark / hrs light):No information in study report

IN-LIFE DATES: From: To:No information in study report
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: Not specified


Doses:
5 g/kg bw
No. of animals per sex per dose:
10 rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: No data
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
No information - as a limit test no statistical analysis is required
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths ina group of ten rats dosed at 5 g/kg
Mortality:
No deaths occurred in a group of ten rats administered a dose of 5g ethylhexyl palmitate/kg bw.
Clinical signs:
piloerection and a wet anogenital region were observed butthe incidence or persistence of these signs is not specified. No indication is given related to recovery.
Body weight:
Not recorded
Gross pathology:
Eight rats were considered normal, macroscopic examination revealed a dark liver for one rat, dark areas on the lungs of one rat and dark kidneys in one case.
Other findings:
None identified
Interpretation of results:
GHS criteria not met
Conclusions:
No deaths occurred in a group of ten ratsdosed at 5g/kg with ethylhexyl palmitate. On basis of read across toa similar material, no acute toxicity is anticipated for fatty acids, C12-2- and C12-20 unsaturated, 2-ethylhexyl esters and no classification for acute oral hazard isrequired according to CLP.
Executive summary:

No deaths occurred in a group of ten rats dosed at 5 g/kg with ethylhexyl palmitate. On basis of read across toa similar material, no acute toxicity is anticipated for fatty acids, C12-2- and C12-20 unsaturated, 2-ethylhexyl esters and no classification for acute oral hazard isrequired according to the CLP Regulation.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited information summarised in a public domain paper, no details of methods, models or guidelines followed.
Qualifier:
no guideline followed
Principles of method if other than guideline:
A limit test determination of acute oral LD50 was conducted in rats
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data
Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
5g/kg
No. of animals per sex per dose:
Not specified
Control animals:
not specified
Details on study design:
No details provided - oral administration of the limit dose to rats
Statistics:
No information - not required for a limit test
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No information in public summary of study report
Clinical signs:
No information in public summary of study report
Body weight:
No information in public summary of study report
Gross pathology:
No information in public summary of study report
Other findings:
No information in public summary of study report

No information in public summary of study report

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 was greater than 5g/kg for ethylhexyl palmitate in rats. On this basis, by read across to similar material, no classification is required for oral toxicity hazard of fatty acids, C12-20 and C12-20 unsaturated, 2-ethylhexyl esters according to CLP.
Executive summary:

The acute oral LD50 for ethyl hexyl palmitate was greater than 5 g/kg in rats; no classification is required for oral toxicity hazard of fatty acids, C12-20 and C12-20 unsaturated, 2-ethylhexyl esters according to CLP.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer-reviewed review of several safety assessments
Qualifier:
no guideline followed
Principles of method if other than guideline:
The standard acute oral study design was used - five males and five females dosed at 8000 mg/kg bw by oral gavage and then observed for 14 days, with bodyweights recorded in life
GLP compliance:
no
Test type:
other: various investigations are reported by various methods for a range of stearates
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
No details provided in report
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not applicable - administered as supplied

MAXIMUM DOSE VOLUME APPLIED: 8 mL/kg bw
Doses:
8.0 g/kg bw
No. of animals per sex per dose:
five males and five females
Control animals:
no
Details on study design:
Undiluted Octyl Stearate was administered to 5 male and 5 female rats at oral doses of 8.0 ml/kg. No further details provided.
Statistics:
No statistical analysis required
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths in a group of ten treated rats
Clinical signs:
No clinical signs of reaction to treatment reported
Body weight:
Bodyweight gains were on average 25.7% over the two week observation period following dosing
Gross pathology:
No information
Other findings:
No additional details

No additional details

Interpretation of results:
GHS criteria not met
Conclusions:
In a group of five male and five female rats exposed by oral gavage to a dose of 8 g/kg bw of octyl stearate, there were no adverse toxic effects. The median lethal dose exceeded the limit dose level for octyl stearate and by read-across no classification for oral toxicity is necessary for fatty acids C12-20 and C12-20 unsaturated, 2-ethylhexyl ester
Executive summary:

In a group of five male and five female rats exposed by oral gavage to a dose of 8 g/kg bw of octyl stearate, there were no adverse toxic effects. The median lethal dose exceeded the limit dose level for octyl stearate and by read-across no classification for oral toxicity is necessary for fatty acids C12-20 and C12-20 unsaturated, 2-ethylhexyl ester

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation 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
Study period:
February 1978
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: A single page summary of the study results is available but insufficient details are present to assess the study reliability accurately
Qualifier:
no guideline followed
Principles of method if other than guideline:
Standard single dose dermal application
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No information in study report
- Humidity (%):No information in study report
- Air changes (per hr):No information in study report
- Photoperiod (hrs dark / hrs light):No information in study report

IN-LIFE DATES: From: To:No information in study report
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
Ne details provided in report
Duration of exposure:
No data
Doses:
5g/kg bw
No. of animals per sex per dose:
10 rabbits in total
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: No data
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
No information - as a limit test no statistical analysis is required
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths in a group of ten rats dosed at 5 g/kg
Mortality:
No deaths occurred in a group of ten rabbits administered a dose of 5g ethylhexyl palmitate/kg bw.
Clinical signs:
No clinical signs were recorded for any of the treated rabbits.
Body weight:
Notrecorded
Gross pathology:
Necropsy revealed several macropscopic changes including :

brown anogenital exudate - 2 rabbits
Intestines, red areas - 3 rabbits; yellow areas - 1 rabbit; bloated - 1 rabbit
Liver, dark - 6 rabbits, mottled appearance - 1 rabbit; white nodules - 1 rabbit.
Dark areas on lungs - 2 rabbits
Other findings:
Nine of the ten rabbits developed slight or moderate erythema and 9/10 also had slight oedema formation.
Interpretation of results:
GHS criteria not met
Conclusions:
No deaths occurred in a group of ten rabbits dosed topically at 5g/kg with ethylhexyl palmitate. On basis of read across toa similar material, no acute dermal toxicity is anticipated for fatty acids, C12-2- and C12-20 unsaturated, 2-ethylhexyl esters and no classification for acute dermal hazard is required according to the CLP Regulation.
Executive summary:

No deaths occurred in a group of ten rabbits dosed topically at 5g/kg with ethylhexyl palmitate. On basis of read across toa similar material, no acute dermal toxicity is anticipated for fatty acids, C12-2- and C12-20 unsaturated, 2-ethylhexyl esters and no classification for acute dermal hazard is required according to the CLP Regulation.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Limited information summarised in a public domain paper, no details of methods, models or guidelines followed.
Qualifier:
no guideline followed
Principles of method if other than guideline:
A limit test determination of acute dermal LD50 was conducted in rabbits
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data
Duration of exposure:
No data
Doses:
5 g/kg bw
No. of animals per sex per dose:
10 rabbits
Control animals:
not specified
Details on study design:
No details provided - dermal application of the limit dose to rabbits
Statistics:
No information - not required for a limit test
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No information in public summary of study report
Clinical signs:
No information in public summary of study report
Body weight:
No information in public summary of study report
Gross pathology:
No information in public summary of study report
Other findings:
No information in public summary of study report

No information in public summary of study report

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 was greater than 5g/kg for ethylhexyl palmitate in rabbits. On this basis, by read across to similar material, no classification is required for dermal toxicity hazard of fatty acids, C12-20 and C12-20 unsaturated, 2-ethylhexyl esters according to the CLP Regulation
Executive summary:

The acute dermal LD50 was greater than 5g/kg for ethylhexyl palmitate in rabbits.  On this basis, by read across to similar material, no classification is required for dermal toxicity hazard of fatty acids, C12-20 and C12-20 unsaturated, 2-ethylhexyl esters according to the CLP Regulation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
8 000 mg/kg bw

Additional information

Acute studies were available by oral and dermal routes of administration. The acute inhalation study was not considered necessary and no read -across data were available for this route of exposure. Oral administration of octyl stearate to rats elicited no signs of toxicity up to a dose of 8000 mg/kg bw. Oral dosing with ethyl hexyl palmitate also resulted in a median lethal dose that exceed the limit of 5 g/kg. The dermal toxicity investigated in rabbits for the analogous material , ethylhexyl palmitate, resulted in a median lethal dose that exceeded the 5 g/kg limit.

Justification for classification or non-classification

Acute toxicity studies conducted with read-across substances do not trigger classification for acute toxicity according to the CLP Regulation.