Castor oil, ethoxylated

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Reproductive toxicity study

Based on the data available from different studies, NOAEL for test material was considered to be 1000mg/kg bw/day .When female rats or mice were treated with test material orally. Thus, comparing this value with the criteria of CLP regulationtest materialisnot likely to classify as reproductive toxicant.

Effect on fertility: via oral route

Endpoint conclusion:

no study available

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

other: Rat or mice

Quality of whole database:

Data is Klimicsh 2 and from authoritative database

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Reproductive toxicity study

Data available from different studies were reviewed to determine the reproductive toxicity of test chemical.The studies are as mentioned below:

Study 1.

A reproductive study was conducted to evaluate the maternal toxicity effects by test material in mouse orally. In first group25 pregnant miceand in second group31 pregnant micewere fed diets containing test substanceand in firstcontrol group 26pregnant mice and insecondcontrol group 28pregnant mic ewere fed untreated feed on daily basis for 6 to 15 days of gestation. During study period test animals were given 0(vehicle), 5000, 10000 mg/kg bw/day.Test materialdoes not show any maternal toxicity.The few malformations observed among the fetuses which is not significant.Hence the no observed adversed effect level (NOAEL) for reproductive toxicity is considered to be 5000 mg/kg bw/day.When female mice treated with test material orally.

Study 2.

13 weeks toxicity study of test material was performed on male and femaleF344/N rats. Animalswere quarantined and acclimated to laboratory conditions for 14 days prior to study start.10 rats /sex/ group were received receiving diets containing0, 620, 1250, 2500, 5000, 10000mg/kg (0, 0.62%, 1.25%, 2.5%, 5.0% or 10%) test material continuously for 13 weeks. Formulated diets were prepared by blending the appropriate amount of test material with a small quantity of feed to prepare a premix. The premix then was layered between the required amounts of feed in a twin-shell blender and blended for 15 minutes to achieve a uniform mix. Formulated diets were stored for no longer than 3 weeks at 5°C; feed hoppers in the animal cages were changed twice weekly. All the animals were observed twice daily for clinical signs.Body weights were recordedinitially and every week thereafter.At the study termination, all animals were euthanized by CO2 anesthesia, and complete necropsies were performed. Complete histopathology examinations were conducted on all rats. Sperm motility and morphology were evaluated at necropsy, and vaginal cytology was evaluated.No mortality observed.No significant differences in average food consumption among each sex were observed, although food consumption of male and female rats in 10000mg/kg dose group was slightly lower than that of controls. Group mean body weights of male rats did not differ significantly from controls, Mean body weights of exposed female rats were slightly lower than the mean body weights of controls but the differences were not dose-related. Haematological effects were not considered biologically significant. Absolute liver weights and the liver-to-body-weight ratio were increased in male rats in 10000mg/kg dose group. Using light microscopy, it was determined there were no morphologic changes associated with the slight differences in organ weights between groups. In male rats, there was a slight decrease in epididymal weight (6-7%) which occurred in the 5000 and 10000 mg/kg dose groups, but this was not dose-related. There were no effects on any other male rat reproductive endpoint, or on any female rat reproductive endpoint. Although there was some variation in epididymal weights, their small magnitude and the absence of changes in other endpoints suggested that there was little or no evidence of any reproductive toxicity associated test material. Histopathology examination revealed an absence of compound-related lesions in any organ or tissue of rats exposed to test material. HenceNo Observed Adverse Effect Level (NOAEL) for reproductive toxicity was considered to be 10000mg/kg, whenmale and femalerats were treated withtest material orallyover 13 weeks.

 

Based on the data available from different studies test chemical did not showedreproductive toxicityat dose concentration 1000mg/kg bw/day by oral route.Hence the test chemical is not likely to classify as a reproductive toxicant as per the criteria mentioned in CLP regulation.

 

 

Effects on developmental toxicity

Description of key information

Developmental toxicity study

Based on the various studies available for the test chemical were reviewed to determine the developmental toxicity, NOAELfor test chemical was considered to be 1000 mg /kg bw/day .When rats or mice were treated with test chemical orally. Thus, comparing this value with the criteria of CLP regulation test chemical is not likely to classify as reproductive and developmental toxicant.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

other: Rat or mice

Quality of whole database:

Data is Klimicsh 2 and from authoritative database

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

Developmental toxicity study

Data available from different studies for test chemicals were reviewed to determine the developmental toxicity of test chemical. The studies are as mentioned below:

Study 1.

A teratogenic study was conducted to evaluate the fetal toxicity effects in the rat fetous by test compound to rats orally. In first group 30 pregnant rats and in second group 27 pregnant rats were fed diets containing test substance and in two control groups of 26 and 29 rats were fed untreated feed on daily basis for 20 days gestation period. During study period test animals were given 0(vehicle), 5000, 10000 mg/kg .Slight but not statistically significant increase occurred in the number of  resorptions in the group treated with 10000 mg/kg.Test materialdoes not show the malformation and anomalies found in the fetuses of the experimental groups were similar to those found among the fetuses from the control groups which are not significant. Overall conclusion of the study is there was no evidence of the test substanceshows any fetal toxicity.Hence the no observed adversed effect level (NOAEL) for teratogenicity study is considered to be 10000 mg/kg. When female rats were treated with test material orally.

Study 2.

A teratogenic study was conducted to evaluate the teratogenicity effects by test compound in mouse orally. In first group25 pregnant miceand in second group31 pregnant micewere fed diets containing test substanceand in firstcontrol group 26pregnant mice and insecondcontrol group 28pregnant micewere fed untreated feed on daily basis for 6 to 15 days of gestation. During study period test animals were given 0(vehicle), 500, 1000 mg/kg bw/day. Test materialdoes not show the malformation in the fetuses of the experimental groups were similar to those found among the fetuses from the control groups which are not significant. Overall conclusion of the study is there was no evidence of the test substanceshows any teratogenicity.Henceno observed adverse effect level (NOAEL) was considered to be 1000 mg/kg bw/day for teratogenicity when mice were administered test material orally.

Thus, Based on the data available fortest chemical,No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg /kg bw . Thus, comparing this value with the criteria of CLP regulationtest chemicalis not likely to classify as reproductive and developmental toxicant.

 

Justification for classification or non-classification

Thus, comparing this value with the criteria of CLP regulation test chemical is not likely to classify as reproductive and developmental toxicant.