Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Repeated dose toxicity: via oral route;

The subchronic study was conducted to evaluate the toxic effects of repeated administration of test chemical.In a 90 - day feeding study, groups of 15 Sherman -Wistar rats were fed diets containing 0.01%, 0.04%, 0.16%, 0.64%, 2.5%, and 5.0% (initially 10 .0%) PEG- 40 Castor Oil . Weight gain , feed intake and hematology results were comparable between the experimental groups and the control group. No significant gross or microscopic lesions were found at either 8 wk or 90 days . Therefore no observed adverse effect level (NOAEL) of repeated dose study was considered to be 5000 mg/kg diet (5.0%).

Repeated inhalation study:

According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Castor oil, ethoxylated which is reported as 7.500617e-36 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical Castor oil, ethoxylated is highly unlikely. Therefore this study is considered for waiver.

Repeated dermal study;

The acute toxicity value for Castor oil, ethoxylated (61791-12-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Castor oil, ethoxylated (61791-12-6) shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Castor oil, ethoxylated shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
5 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
K2 data from a wualified publication.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The data available for the test chemical was reviewed to determine the toxic nature Castor oil, ethoxylated (61791-12-6) repeated exposure by oral route. The study is as mentioned below:

Repeated dose toxicity: via oral route;

The sub chronic study was conducted to evaluate the toxic effects of repeated administration of test chemical .In a 90 - day feeding study, groups of 15 Sherman -Wistar rats were fed diets containing 0.01%, 0.04%, 0.16%, 0.64%, 2.5%, and 5.0% (initially 10 .0%) PEG- 40 Castor Oil .Weight gain, feed intake and hematology results were comparable between the experimental groups and the control group. No significant gross or microscopic lesions were found at either 8 week or 90 days. Therefore no observed effect level (NOEL) of repeated dose study was considered to be 5000 mg/kg diet (5.0%).

Other subchronic study was conducted to evaluate the toxic effects of repeated administration of test chemical .In a 90 - day feeding study, each of 1 beagle dog were fed diets containing 0.04% ,0.64% or 5.0% test chemical .No significant difference was observed in weight gain ,feed intake and hematology. At necropsy, perilobular cellular infiltration and parasitic granulomas were observed , but these conditions also were present in the control animals and were attributed to parasitic infection and migration rather than a treatment - related effect. Therefore the no observed adverse effect level (NOAEL) of repeated dose study was considered to be 1250 mg/kg diet (5.0%).

Based on the data available for the test chemical, Castor oil, ethoxylated (61791-12-6) does not exhibit repeated dose oral toxicity in dose range 1250 -5000 mg/kg bw in rodent as well as in mammal. Hence the test chemical is not likely to classify as a repeated dose oral toxicity as per the criteria mentioned in CLP regulation.

Repeated inhalation study:

According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Castor oil, ethoxylated which is reported as 7.500617e-36 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical Castor oil, ethoxylated is highly unlikely. Therefore this study is considered for waiver.

Repeated dermal study;

The acute toxicity value for Castor oil, ethoxylated (61791-12-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Castor oil, ethoxylated (61791-12-6) shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Castor oil, ethoxylated shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.

Based on the data available for the test chemical Castor oil, ethoxylated (CAS no. 61791-12-6) does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the data available for the test chemical Castor oil, ethoxylated (CAS no. 61791-12-6) does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.

Categories Display