Castor oil, ethoxylated

Endpoint summary

Description of key information

Acute oral toxicity: 

Acute oral toxicity dose (LD50) of the test chemical was considered based on experimental study conducted on mice, the LD50 value was considered to be 6500 mg/kg bw. The study concluded that the LD50 value 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: 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the test chemical, which is reported as 7.55E-36 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.

Acute Dermal Toxicity:

Acute Dermal toxicity dose (LD50) for the test chemical was considered based on experimental study conducted on rats, the value was considered to be >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 500 mg/kg bw

Quality of whole database:

Data is from secondary source.

Acute toxicity: via inhalation route

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 1 and from experimental study report.

Additional information

Acute oral toxicity:

In different studies, the given test chemical 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 and mice for test chemical. The studies are summarized as below –

The experimental study mentioned in secondary source and conducted in mice was designed to determine acute oral toxicity dose of test chemical. The study was conducted in mice at the dose concentration of 6500 mg/kg bw. 50% mortality was observed in treated mice. Hence, LD50 value value was considered to be 6500 mg/kg bw, when mice were treated with the given test chemical via oral route.

In another study, acute oral toxicity dose was determined for the test chemical. The study was conducted in rats at the dose concentration of 2000 mg/kg bw. No mortality was observed in treated rats. Hence, LD50 value was considered to be >2000 mg/kg bw, when rats were treated with the given test chemical via oral route.

Above studies are supported with the data mentioned in authoritative database and conducted in mice. The acute oral toxicity study of test chemical was conducted in mice at the dose concentration of 5000 mg/kg bw. 50% mortality was observed in treated mice. Hence, LD50 value was considered to be 5000 mg/kg bw, when mice were treated with the given test chemical via oral route.

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

Acute Inhalation toxicity: 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the test chemical, which is reported as 7.55E-36 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.

Acute Dermal toxicity:

Acute dermal toxicity study of the given test chemical was conducted as per OECD No.402 in Wistar rats. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/kg body weight of test item was applied by single dermal application and observed for 14 days after treatment. On test day 0, as such test item was applied directly on the intact skin of clipped area of rats; the surgical gauze patch was put on to the intact skin of clipped area. This surgical gauze patch was covered with a non-irritating adhesive tape. The dressing was wrapped around the abdomen and anchored with non-irritating adhesive tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed. The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs/Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. In males, animal nos. 1 to 4 were normal throughout the experimental period, while animal no. 5 was observed normal at 1, 2, 3, 4 hours and from day 1 to 5 and with mild alopecia on day 6 to 8 followed by normal clinical sign till day 14. In females, animal no. 6 was observed normal at 1, 2, 3, 4 hours and on day 1, mild erythema from day 2 to 7, mild scaling on day 6 and 7 and scab from day 8 to 10 followed by normal clinical sign till day 14. Animal no. 7 was observed normal at 1, 2, 3, 4 hours and from day 1 to 5 and mild alopecia from day 6 to 10 followed by normal clinical sign till day 14. Animal no. 8 was observed normal at 1, 2, 3, 4 hours and on day 1, mild erythema from day 2 to 7 and scab on day 8 followed by normal clinical sign till day 14.Animal no. 9 was observed normal throughout the experimentation period. Animal no. 10 was observed normal at 1, 2, 3, 4 hours and on day 1, mild erythema from day 2 to 7, mild scaling from day 5 to 7 and scab from day 8 to 10 followed by normal clinical sign till day 14. The body weight gain was observed in male and female animals on day 7 and 14 as compared to day 0, except decline in mean body weight gain was observed in males on day 7. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Under the conditions of this, the acute dermal median lethal dose LD50 was considered to be >2000 mg/kg body weight, when Wistar rats were treated with given test chemical by dermal application. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

In another study, the acute dermal toxicity study of test chemical was conducted according to OECD guideline 402 for testing of chemicals on Wistar albino rats. The summary of the study was as follows - In limit test: Ten healthy wistar albino rats of both sexes (ranging b.wt 190±40 gm) were selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test compound was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were closely observed for clinical signs of intoxication during first four hours of test compound administration. Thereafter, all the animals were observed periodically at one hour interval for 24 hrs and twice daily for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals at termination of the study. The test compound applied at the dose level of 2000 mg/kg b.wt in Wistar albino rats did not show any mortality as well as clinical signs of toxicity throughout the observation period of 14 days.  Necropsy finding did not reveal any gross pathological changes related to compound toxicity. After 72 hrs, a confirmatory test was conducted in same species of animals to confirm the results obtained from limit test (OECD-402 guidelines). Ten healthy Wistar albino rats of both sexes (ranging b.wt 200±20 gm) were selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test chemical was applied dermally at the dose level of 2000 mg/kg b.wt for each animal. The treated animals were closely observed for clinical signs of intoxication during first four hours of test compound administration. Thereafter, all the animals were observed periodically at one hour interval for 24 hrs and twice daily for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7th and 14th (post treatment). The necropsy was performed on all animals at the termination of the study. No mortality was recorded in Wistar albino rats after administration of test compound at the dose level of 2000 mg/kg b.wt throughout the period of observation (14 days). The test compound did not elicit any clinical signs of toxicity during the observation period. No skin reaction was observed after 24th hrs of patch removal. The body weight of each animal recorded on day 7th and 14th showed normal increase as compared to day 0 (pre treatment). Based on the results obtained from present investigation, it can be concluded that the acute dermal toxicity dose LD50 value of the test compound when applied dermally to male and female Wistar albino rats was considered to be >2000 mg/kg body weight. Hence, it is acutely non toxic.

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

Justification for classification or non-classification

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