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Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Castor oil, hydrogenated, ethoxylated
EC Number:
500-147-5
EC Name:
Castor oil, hydrogenated, ethoxylated
Cas Number:
61788-85-0
Molecular formula:
C57H110O9 (C2H4O)n where n = 1-6.5
IUPAC Name:
Castor oil, hydrogenated, ethoxylated
Test material form:
solid
Remarks:
pasty wax

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
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
Body weight:
within normal ranges
Gross pathology:
no abnormalities observed

Applicant's summary and conclusion

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.