Castor oil, sulfated

Endpoint summary

Description of key information

Acute oral toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Castor oil, sulfated (CAS no.: 8002-33-3). The studies are as mentioned below:

1. Acute Oral toxicity study was conducted by using test chemical in 20 fasted rats at oral dose 39.8 g/kg as a 90% w/v concentration in corn oil. Animals were observed for mortality for 14 days. No mortality was observed at 39800 mg/kg bw. Therefore, LD50 was considered to be >39800 mg/kg bw, when 20 male and female rats were treated with test chemical via oral route.

2. Acute Oral toxicity study was conducted by using test chemical in 10 Sprague-Dawley rats at oral dose 20.0 g/kg bw. Animals were observed for mortality for 14 days. Necropsy was performed. No mortality was observed at 20000 mg/kg bw. At necropsy, none of the animals had gross lesions. Therefore, LD50 was considered to be >20000 mg/kg bw, when 10 male and female Sprague-Dawley rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, Castor oil, sulfated (CAS no.: 8002-33-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, sulfated (CAS no.: 8002-33-3) cannot be classified for acute oral toxicity. Hence, Castor

oil, sulfated is not likely to be toxic in the dose range of >20000 - >39800 mg/Kg bw.

Acute Dermal Toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical Castor oil, sulfated (CAS no.: 8002-33-3). The studies are as mentioned below:

1. Acute Dermal toxicity study was conducted by using test chemical in 8 male and female albino rabbits at dose of 6800 mg/kg and 10200 mg/kg bw. 2 groups of 2 male and 2 female albino rabbits received a 24-hour patch test of a cosmetic cleansing cream containing 3% test chemical. One group received the undiluted product in a dose of 6.8 g/kg; the other, 10.2 g/kg. Animals were observed for mortality and clinical signs for 14 days. No mortality was observed at 10200 mg/kg bw. Abnormal behaviour, adverse body weight changes, or gross alterations were noted during the 14-day observation period. At the end of the 24-hour contact period, definite red, well-defined erythema was observed at the contact site on each animal. The erythema subsided by Day 7. Therefore, LD50 was considered to be >10200 mg/kg bw, when 8 male and female albino rabbits were treated with test chemical by dermal application.

2. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that given test chemical does not classify as an acute dermal toxicant.  CLP Classification: “Not classified”.

Thus, based on the above summarised studies, Castor oil, sulfated (CAS no.: 8002-33-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, sulfated (CAS no.: 8002-33-3) cannot be classified for acute dermal toxicity. Hence, Castor oil, sulfated is not likely to be toxic in the dose range of >2000 - >10200 mg/Kg bw 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 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

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

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

GLP compliance:

not specified

Test type:

other:

Limit test:

no

Specific details on test material used for the study:

Name: Castor oil, sulfated
Smiles:CCCCCCC(OS(=O)(=O)[O-])C/C=C\CCCCCCCC(=O)OCC(OC(=O)CCCCCCC/C=C\CC(OS(=O)(=O)[O-])CCCCCC)COC(=O)CCCCCCC/C=C\CC(OS(=O)(=O)[O-])CCCCCC.[Na+].[Na+].[Na+]
InChI:1S/C57H104O18S3.3Na/c1-4-7-10-31-40-51(73-76(61,62)63)43-34-25-19-13-16-22-28-37-46-55(58)70-49-54(72-57(60)48-39-30-24-18-15-21-27-36-45-53(75-78(67,68)69)42-33-12-9-6-3)50-71-56(59)47-38-29-23-17-14-20-26-35-44-52(74-77(64,65)66)41-32-11-8-5-2;;;/h25-27,34-36,51-54H,4-24,28-33,37-50H2,1-3H3,(H,61,62,63)(H,64,65,66)(H,67,68,69);;;/q;3*+1/p-3/b34-25-,35-26-,36-27-;;;
Molecular Weight: 1239.5749 g/mole

Species:

rat

Strain:

other: 1. not specified 2. Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

1. TEST ANIMALS
- Fasting period before study: Fasting was done
2. TEST ANIMALS
- Weight at study initiation: males and females; weights = 150 to 300 g

Route of administration:

other: 1. oral: unspecified 2. oral: unspecified

Vehicle:

other: 1. corn oil 2. unchanged (no vehicle)

Details on oral exposure:

1. VEHICLE
- Concentration in vehicle: 90% w/v concentration in corn oil.
2. not specified

Doses:

1. 39800 mg/kg bw
2. 20000 mg/kg bw

No. of animals per sex per dose:

1. 20 rats (Sex/Dose)
2. 10 rats

Control animals:

other: 1. not specified 2. not specified

Details on study design:

1. - Duration of observation period following administration: 14 days
- Other examinations performed: Animals were observed for mortality.
2. - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: Animals were observed for mortality.

Statistics:

1. not specified
2. not specified

Preliminary study:

1. not specified
2. not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 39 800 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

1. No mortality was observed at 39800 mg/kg bw
2. No mortality was observed at 20000 mg/kg bw

Clinical signs:

1. not specified
2. not specified

Body weight:

1. not specified
2. not specified

Gross pathology:

1. not specified
2. At necropsy, none of the animals had gross lesions.

Other findings:

1. not specified
2. not specified

Interpretation of results:

other: Not classified

Conclusions:

The test chemcial Castor oil, sulfated (CAS no.: 8002-33-3) is not likely to be toxic in the dose range of >20000 - >39800 mg/Kg bw for acute oral toxicity.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Castor oil, sulfated (CAS no.: 8002-33-3). The studies are as mentioned below:

1. Acute Oral toxicity study was conducted by using test chemical in 20 fasted rats at oral dose 39.8 g/kg as a 90% w/v concentration in corn oil. Animals were observed for mortality for 14 days. No mortality was observed at 39800 mg/kg bw. Therefore, LD50 was considered to be >39800 mg/kg bw, when 20 male and female rats were treated with test chemical via oral route.

 2. Acute Oral toxicity study was conducted by using test chemical in 10 Sprague-Dawley rats at oral dose 20.0 g/kg bw. Animals were observed for mortality for 14 days. Necropsy was performed. No mortality was observed at 20000 mg/kg bw. At necropsy, none of the animals had gross lesions. Therefore, LD50 was considered to be >20000 mg/kg bw, when 10 male and female Sprague-Dawley rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, Castor oil, sulfated (CAS no.: 8002-33-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, sulfated (CAS no.: 8002-33-3) cannot be classified for acute oral toxicity. Hence, Castor oil, sulfated is not likely to be toxic in the dose range of >20000 - >39800 mg/Kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

39 800 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from publication.

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:

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

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

WoE report is based on 2 acute dermal toxicity studies as- WoE-2 and WoE-3.
Acute Dermal 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

Specific details on test material used for the study:

Name: Castor oil, sulfated
Smiles:CCCCCCC(OS(=O)(=O)[O-])C/C=C\CCCCCCCC(=O)OCC(OC(=O)CCCCCCC/C=C\CC(OS(=O)(=O)[O-])CCCCCC)COC(=O)CCCCCCC/C=C\CC(OS(=O)(=O)[O-])CCCCCC.[Na+].[Na+].[Na+]
InChI:1S/C57H104O18S3.3Na/c1-4-7-10-31-40-51(73-76(61,62)63)43-34-25-19-13-16-22-28-37-46-55(58)70-49-54(72-57(60)48-39-30-24-18-15-21-27-36-45-53(75-78(67,68)69)42-33-12-9-6-3)50-71-56(59)47-38-29-23-17-14-20-26-35-44-52(74-77(64,65)66)41-32-11-8-5-2;;;/h25-27,34-36,51-54H,4-24,28-33,37-50H2,1-3H3,(H,61,62,63)(H,64,65,66)(H,67,68,69);;;/q;3*+1/p-3/b34-25-,35-26-,36-27-;;;
Molecular Weight: 1239.5749 g/mole

Species:

other: 1. rabbits 2. rat

Strain:

other: 1. Albino rabbits 2. Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

1. not specified
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 %)
Female - Mean : 218.66 g (= 100 %); Minimum : 212.7 g (- 2.73 %); Maximum : 222.2 g (+ 1.62 %)
- 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: 1. patch test 2. semiocclusive

Vehicle:

other: 1. cosmetic cleansing cream 2. Distilled water

Details on dermal exposure:

1. VEHICLE
- Concentration in vehicle: cosmetic cleansing cream containing 3% Sorbitan Sesquioleate.
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
- Constant volume or concentration used: No data available
- For solids, paste formed: Yes
VEHICLE
- Amount(s) applied (volume or weight with unit): No data available
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

Duration of exposure:

1. 24 hour
2. 24 hour

Doses:

1. 6800 mg/kg and 10200 mg/kg bw
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).

No. of animals per sex per dose:

1. Total = 8 (2 groups of 2 male and 2 female albino rabbits) Group 1 – 6800 mg/kg bw – 2M, 2F; Group 2 – 10200 mg/kg bw – 2M, 2F
2. 10 (5/sex).

Control animals:

not specified

Details on study design:

1. - Duration of observation period following administration: 14 days
- Other examinations performed: Animals were observed for mortality and clinical signs.
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).

Statistics:

1. not specified
2. not specified

Preliminary study:

1. not specified
2. not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 200 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

1. No mortality was observed at 10200 mg/kg bw
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.

Clinical signs:

1. Abnormal behavior, adverse body weight changes, or gross alterations were noted during the 14-day observation period. At the end of the 24-hour contact period, definite red, well-defined erythema was observed at the contact site on each animal. The erythema subsided by Day 7.
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 in any signs of toxicity during the study period of 14 days.

Body weight:

1. not specified
2. Sex : Male Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 9.04% and 18.02% respectively.
Sex : Female Group I (2000 mg/kg) - Percent body weight gain after 7 days and 14 days was found to be 5.77% and 9.62% respectively.

Gross pathology:

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

Other findings:

1. not specified
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.

Interpretation of results:

other: Not classified

Conclusions:

The test chemcial Castor oil, sulfated (CAS no.: 8002-33-3) is not likely to be toxic in the dose range of >2000 - >10200 mg/Kg bw for acute dermal toxicity.

Executive summary:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical Castor oil, sulfated (CAS no.: 8002-33-3). The studies are as mentioned below:

1. Acute Dermal toxicity study was conducted by using test chemical in 8 male and female albino rabbits at dose of 6800 mg/kg and 10200 mg/kg bw. 2 groups of 2 male and 2 female albino rabbits received a 24-hour patch test of a cosmetic cleansing cream containing 3% test chemical. One group received the undiluted product in a dose of 6.8 g/kg; the other, 10.2 g/kg. Animals were observed for mortality and clinical signs for 14 days. No mortality was observed at 10200 mg/kg bw. Abnormal behaviour, adverse body weight changes, or gross alterations were noted during the 14-day observation period. At the end of the 24-hour contact period, definite red, well-defined erythema was observed at the contact site on each animal. The erythema subsided by Day 7. Therefore, LD50 was considered to be >10200 mg/kg bw, when 8 male and female albino rabbits were treated with test chemical by dermal application.

2. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that given test chemical does not classify as an acute dermal toxicant.  CLP Classification: “Not classified”.

Thus, based on the above summarised studies, Castor oil, sulfated (CAS no.: 8002-33-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, sulfated (CAS no.: 8002-33-3) cannot be classified for acute dermal toxicity. Hence, Castor oil, sulfated is not likely to be toxic in the dose range of >2000 - >10200 mg/Kg bw for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 200 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from publication.

Additional information

Acute oral toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Castor oil, sulfated (CAS no.: 8002-33-3). The studies are as mentioned below:

1. Acute Oral toxicity study was conducted by using test chemical in 20 fasted rats at oral dose 39.8 g/kg as a 90% w/v concentration in corn oil. Animals were observed for mortality for 14 days. No mortality was observed at 39800 mg/kg bw. Therefore, LD50 was considered to be >39800 mg/kg bw, when 20 male and female rats were treated with test chemical via oral route.

2. Acute Oral toxicity study was conducted by using test chemical in 10 Sprague-Dawley rats at oral dose 20.0 g/kg bw. Animals were observed for mortality for 14 days. Necropsy was performed. No mortality was observed at 20000 mg/kg bw. At necropsy, none of the animals had gross lesions. Therefore, LD50 was considered to be >20000 mg/kg bw, when 10 male and female Sprague-Dawley rats were treated with test chemical via oral route.

Thus, based on the above summarised studies, Castor oil, sulfated (CAS no.: 8002-33-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, sulfated (CAS no.: 8002-33-3) cannot be classified for acute oral toxicity. Hence, Castor

oil, sulfated is not likely to be toxic in the dose range of >20000 - >39800 mg/Kg bw.

Acute Dermal Toxicity:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical Castor oil, sulfated (CAS no.: 8002-33-3). The studies are as mentioned below:

1. Acute Dermal toxicity study was conducted by using test chemical in 8 male and female albino rabbits at dose of 6800 mg/kg and 10200 mg/kg bw. 2 groups of 2 male and 2 female albino rabbits received a 24-hour patch test of a cosmetic cleansing cream containing 3% test chemical. One group received the undiluted product in a dose of 6.8 g/kg; the other, 10.2 g/kg. Animals were observed for mortality and clinical signs for 14 days. No mortality was observed at 10200 mg/kg bw. Abnormal behaviour, adverse body weight changes, or gross alterations were noted during the 14-day observation period. At the end of the 24-hour contact period, definite red, well-defined erythema was observed at the contact site on each animal. The erythema subsided by Day 7. Therefore, LD50 was considered to be >10200 mg/kg bw, when 8 male and female albino rabbits were treated with test chemical by dermal application.

2. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. 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. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that given test chemical does not classify as an acute dermal toxicant.  CLP Classification: “Not classified”.

Thus, based on the above summarised studies, Castor oil, sulfated (CAS no.: 8002-33-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, sulfated (CAS no.: 8002-33-3) cannot be classified for acute dermal toxicity. Hence, Castor oil, sulfated is not likely to be toxic in the dose range of >2000 - >10200 mg/Kg bw for acute dermal toxicity.

Justification for classification or non-classification

Based on the above experimental studies on Castor oil, sulfated (CAS no.: 8002-33-3) and it’s structurally similar related read across substances, 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, Castor oil, sulfated cannot be classified for acute oral and dermal toxicity.