Octadecyl stearate

Endpoint summary

Description of key information

Acute oral Toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2500 mg/kg bw. The study concluded that LD50 is >2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity: 

Test chemical has very low vapour pressure (2.16E-09 Pa. = 1.620133003827e-11 mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.

Acute dermal Toxicity: 

The acute dermal toxicity dose (LD50) for test chemical was based on data available for the test chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute dermal toxicity. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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:

data from handbook or collection of data

Remarks:

Experimental data from various test chemicals

Justification for type of information:

Data for the target chemical is summarized based on the available information from various test chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE for the target CAS is summarized based on data from various test chemicals.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

rat

Strain:

other: 2.not specified 3.not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

2.not specified
3.not specified

Route of administration:

other: 2.oral: unspecified 3.oral: gavage

Vehicle:

other: 2.not specified 3.olive oil

Details on oral exposure:

2.not specified
3.VEHICLE
- Concentration in vehicle: 2000 and 2500 mg/kg
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle: olive oil

Doses:

2.2500 mg/kg bw
3.2000 and 2500 mg/kg bw

No. of animals per sex per dose:

2.not specified
3.Total: 15
2000 mg/kg: 5 rat
2500 mg/kg: 10 rat

Control animals:

not specified

Details on study design:

2.not specified
3.- Duration of observation period following administration: No data available
- Frequency of observations and weighing: No data available
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality and gross pathology were examined.

Statistics:

2.not specified
3.No data available

Preliminary study:

2.not specified
3.No data available

Sex:

not specified

Dose descriptor:

LD50

Remarks:

2.

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Sex:

not specified

Dose descriptor:

LD50

Remarks:

3.

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

2.No mortality was observed in treated rats at 2500 mg/kg bw
3.No mortality was observed in treated rat at 2000 and 2500 mg/kg bw

Clinical signs:

other: 2.not specified 3.not specified

Gross pathology:

2.not specified
3.No lesions of the liver, spleen, stomach, or intestines were in treated rat at necropsy in the rats that died during the study or in those killed at the termination of the study.

Other findings:

2.not specified
3.not specified

Interpretation of results:

other: not classified

Conclusions:

According to CLP regulation,the test chemical cannot be classified for acute oral toxicity, as the LD50 value is >2000 mg/kg bw.

Executive summary:

Data available for the test chemical has been reviewed to determine the acute oral toxicity of the test chemical.The studies are as mentioned below:

In a acute oral toxicity study, rats were treated with test chemical orally.  No mortality was observed in treated rats at 2500 mg/kg bw.Therefore, LD50 value was considered to be > 2500 mg/kg bw,when rat were treated with test chemical orally.  

In another acute oral toxicity study, rat were treated with test chemical in the concentration of 2000 and 2500 mg/kg bw in olive oil orally. No mortality was observed in treated rat at 2000 and 2500 mg/kg bw. No lesions of the liver, spleen, stomach, or intestines were observed in treated rat. At necropsy in the rats that died during the study or in those killed at the termination of the study. Therefore,LD50 was considered to be > 2500 mg/kg bw,when rat were treated with test chemical orally via gavage.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 500 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from Publication.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Clinical signs:

other:

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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:

data from handbook or collection of data

Remarks:

Experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on two acute dermal toxicity studies as-WoE- 2;3 and 4.
Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

other: 2. rat 3. rabbit 4.rabbit

Strain:

other: 2.Sprague-Dawley 3.not specified 4.not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

2.TEST ANIMALS
- Source: National Institute of Biosciences, Pune.
- Females nulliparous and non-pregnant: No data available
- Age at study initiation: Young adult male and female rats aged between 8 – 12 weeks were used.
- Weight at study initiation: The weight range of approximately 212.7 to 250.8 grams at initiation of dosing.
Body weights at the start :
Male
Mean : 245.18 g (= 100 %)
Minimum : 236.8 g (- 3.42 %)
Maximum : 250.8 g (+ 2.29 %)
Total No. of animals : 5
Female
Mean : 218.66 g (= 100 %)
Minimum : 212.7 g (- 2.73 %)
Maximum : 222.2 g (+ 1.62 %)
Total No. of animals : 5
- Identification: Each rat was individually identified by the cage number.
- Fasting period before study: No data available
- Housing: The rats were individually housed in polycarbonate cages with paddy husk as bedding.
- Diet (e.g. ad libitum): Rodent feed supplied by the Nutrivet Life Sciences, Pune, was provided ad libitum from individual feeders.
- Water (e.g. ad libitum): Water was provided ad libitum from individual bottles attached to the cages. All water was from a local source and passed through the reverse osmosis membrane before use.
- Acclimation period: 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 to 21.6 degree centigrade.
- Humidity (%): 55.0% to 58.4%.
- Air changes (per hr): Ten to fifteen air changes per hour.
- Photoperiod (hrs dark / hrs light): An artificial light and dark cycle of 12 hours each was provided to the room.

IN-LIFE DATES: 12-06-2017 to 27-06-2017

Type of coverage:

other: 2.semiocclusive 3. dermal 4.dermal

Vehicle:

other: 2.Distilled water 3.eyeshadow form

Details on dermal exposure:

2.TEST SITE
- Area of exposure: Trunk (dorsal surface and sides from scapular to pelvic area)
- % coverage: Approximately 10% of the body surface area.
- Type of wrap if used: Porous gauze dressing and non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water was used to remove residual test item.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: Yes

3.DOSAGE PREPARATION (if unusual):Dose were applied 10 % in eyeshadow form.

Duration of exposure:

2.24 hours
3.not specified

Doses:

2.A single dose of 2000 mg of the test item per kilogram of body weight was administered to ten rats (five males and five females).
3.2000 mg/kg bw
4.5000mg/kg bw

No. of animals per sex per dose:

2.10 (5/sex).
3.10

Control animals:

not specified

Details on study design:

2.- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical Observations and General Appearance:Animals were observed for clinical signs, mortality, until sacrifice.
Onset, duration and severity of any sign were recorded. The clinical signs and mortality observations were conducted at 10, 30, 60 minutes, 2, 4 and 6 hours on the day of dosing and once daily thereafter for 14 day. Daily observation was done as far as possible at the same time.
The observations were included general clinical signs, observations of eyes, mucous membranes, respiratory, circulatory system and behavior pattern.
Evaluation of Dermal Reaction:Dermal reaction was observed daily for study period of 14 days.
Body weights:Individual animal body weights were recorded pre-test (prior to administration of the test item), day 7 and at termination on day 14.
Gross Pathology:Necropsy was performed on animals surviving at the end of the study. Macroscopic examination of all the orifices, cavities and tissues were made and the findings were recorded. All animals surviving the study period were sacrificed by the carbon dioxide asphyxiation technique (day 15).
Histopathology:No gross abnormalities were observed in animals sacrificed terminally hence, no histopathology was performed.

3.not specified

Statistics:

not specified

Preliminary study:

not specified

Sex:

male/female

Dose descriptor:

LD50

Remarks:

2.

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality observed

Sex:

not specified

Dose descriptor:

LD50

Remarks:

3.

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Sex:

not specified

Dose descriptor:

LD50

Remarks:

4.

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

2.Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.
Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight: All animals survived through the study period of 14 days.

3.no mortality was observed at dose 2000 mg/kg bw

4.No mortality was observed

Clinical signs:

other: 2.Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any signs of toxicity during the study period of 14 days. Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result

Gross pathology:

2.Gross pathological examination did not reveal any abnormalities in animals from 2000 mg/kg dose group.
3.not specified

Other findings:

2.- Other observations: Evaluation of Dermal Reaction
Sex : Male Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.
Sex : Female Group I - Animal treated at the dose level of 2000 mg/kg body weight did not result in any skin reaction during the study period of 14 days.

3.not specified

Interpretation of results:

other: not classified

Conclusions:

According to CLP regulation,the test chemical cannot be classified for acute dermal toxicity, as the LD50 value is >2000 mg/kg bw.

Executive summary:

Data available for the test chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical.The studies are as mentioned below:

The acute dermal toxicity profile of test chemical in Sprague Dawley rats according to OECD Guideline 402 (Acute Dermal Toxicity). The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. Thus, The LD50 value was considered to be >2000 mg/kg bw,when male and female Sprague Dawley rats were semiocclusively treated with test chemical  by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).

In a acute dermal toxicity study, 10 rabbits were treated with test chemical in the concentration 2000 mg/kg dermally as a 10 % in eye shadow form. No effect on survival of treated rabbits was observed to be 2000 mg/kg. Therefore, LD50 value was considered to be > 2000 mg/kg bw,when rabbits were treated with test chemical dermally as a 10 % in eye shadow form.

Moreover,Acute dermal toxicity study was done in rabbit using test chemical.No mortality was observed at dose 5000 mg/kg bw. Hence the LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical by dermal application.

Thus, based on the above summarised studies of test chemical, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from prediction report.

Additional information

Acute oral Toxicity: 

Data available for the test chemical has been reviewed to determine the acute oral toxicity of the test chemical.The studies are as mentioned below:

In a acute oral toxicity study, rats were treated with test chemical orally.  No mortality was observed in treated rats at 2500 mg/kg bw.Therefore, LD50 value was considered to be > 2500 mg/kg bw,when rat were treated with test chemical orally.  

In another acute oral toxicity study, rat were treated with test chemical in the concentration of 2000 and 2500 mg/kg bw in olive oil orally. No mortality was observed in treated rat at 2000 and 2500 mg/kg bw. No lesions of the liver, spleen, stomach, or intestines were observed in treated rat. At necropsy in the rats that died during the study or in those killed at the termination of the study. Therefore,LD50 was considered to be > 2500 mg/kg bw,when rat were treated with test chemical orally via gavage.

Thus, based on the above summarised studies on test chemical, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute oral toxicity.

Acute Inhalation Toxicity:

Test chemical has very low vapour pressure (2.16E-09 Pa. = 1.620133003827e-11 mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.

Acute dermal Toxicity: 

Data available for the test chemicals has been reviewed to determine the Acute dermal toxicity of the test chemical.The studies are as mentioned below:

The acute dermal toxicity profile of test chemical in Sprague Dawley rats according to OECD Guideline 402 (Acute Dermal Toxicity). The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. Thus, The LD50 value was considered to be >2000 mg/kg bw,when male and female Sprague Dawley rats were semiocclusively treated with test chemical  by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity).

In a acute dermal toxicity study, 10 rabbits were treated with test chemical in the concentration 2000 mg/kg dermally as a 10 % in eye shadow form. No effect on survival of treated rabbits was observed to be 2000 mg/kg. Therefore, LD50 value was considered to be > 2000 mg/kg bw,when rabbits were treated with test chemical dermally as a 10 % in eye shadow form.

Moreover,Acute dermal toxicity study was done in rabbit using test chemical.No mortality was observed at dose 5000 mg/kg bw. Hence the LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical by dermal application.

Thus, based on the above summarised studies of test chemical, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute dermal toxicity.

Justification for classification or non-classification

Based on the above experimental studies on Test chemical, it can be concluded that LD50 value is >2000 mg/kg bw for acute oral and dermal toxicity.Thus, comparing this value with the criteria of CLP regulation,Test chemical cannot be classified for acute oral and dermal toxicity. For Acute inhalation toxicity waiver was added so, not possible to classify.