Castor oil, hydrogenated, ethoxylated

Endpoint summary

Description of key information

In a fixed dose procedure 5 female rats received a single dose of 2000 mg/kg bw by gavage. Rats were observed for 14 days thereafter. No mortality occurred. One female showed hunched posture, ataxia, noisy respiration, increased salivation and lethargy during the first day. The other females showed hunched posture during the first 2 hours after dosing. There were no effects on body weight and no macroscopic findings. Based on these findings the oral LD50 of the substance is > 2000 mg/kg bw.

As the substance is of low acute oral toxicity, is not classified as STOT SE and there are no other signs of systemic toxicity, the acute dermal toxicity study has been waived. As the inhalation exposure route is not relevant for this substance no acute study via the inhalation route is included.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 November 2017 to 27 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Strain: RccHan™:WIST
- Females (if applicable) nulliparous and non-pregnant:yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 164-188 g
- Fasting period before study: overnight before dosing and 3-4 hours after dosing
- Housing: solid-floor polypropylene cages furnished with woodflakes (maximum 4/cage)
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15/hour
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: solubility, substance was not soluble in water or arachis oil

MAXIMUM DOSE VOLUME APPLIED: 10 mL

Doses:

2000 mg/kg bw 1 female
2000 mg/kg bw 4 additional females

No. of animals per sex per dose:

5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
mortality: twice daily (once in weekends)
clinical signs: 30 minutes, 1, 2, and 4 hours after dosing and then daily for up to 14 days
bodyweight: day 0, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

NA

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: in the first female on day 1: hunched posture, ataxia, noisy respiration, increased salivation and lethargy other females: during first 2 hours after dosing: hunched posture

Gross pathology:

no abnormalities observed

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 of the substance is > 2000 mg/kg bw

Executive summary:

In a fixed dose procedure 5 female rats received a single dose of 2000 mg/kg bw by gavage. Rats were observed for 14 days thereafter. No mortality occurred. One female showed hunched posture, ataxia, noisy respiration, increased salivation and lethargy during the first day. The other females showed hunched posture during the first 2 hours after dosing. There were no effects on body weight and no macroscopic findings. Based on these findings the oral LD50 of the substance is > 2000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

As the substance is of low acute oral toxicity, is not classified as STOT SE and there are no other signs of systemic toxicity, the acute dermal toxicity study has been waived. As the inhalation exposure route is not relevant for this substance no acute study via the inhalation route is included.

Justification for classification or non-classification

Based on the available information no classification for acute toxicity is necessary according to Regulation (EC) No 1272/2008 (CLP).