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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Experimental start date28 September 2016 Experimental completion date 18 October 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Soybean oil, maleated, ester with triethanolamine
EC Number:
285-107-2
EC Name:
Soybean oil, maleated, ester with triethanolamine
Cas Number:
85029-82-9
Molecular formula:
C63H113NO12 to C67H123NO12
IUPAC Name:
Soybean oil, maleated, ester with triethanolamine
Test material form:
other: Clear amber viscous liquid
Details on test material:
100% product
Physical state/Appearance: Clear amber viscous liquid
Expiry Date: 24 June 2018
Storage Conditions: Room temperature in the dark

Specific details on test material used for the study:
Identification: Test item
Physical state/Appearance: Clear amber viscous liquid
Purity: 100% wt - (UVCB)
Expiry Date: 24 June 2018
Storage Conditions: Room temperature, in the dark

Test animals

Species:
rat
Strain:
other: Wistar (RccHan™:WIST) strain rats
Sex:
female
Details on test animals or test system and environmental conditions:
Female Wistar (RccHan™:WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible
ink-marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the mean body weight at the start of treatment.
The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.

The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
For the purpose of the study the test item was freshly prepared, as required, as a solution in distilled water.
Details on oral exposure:
For the purpose of the study the test item was freshly prepared, as required, as a solution in distilled water.

The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.

No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation. This is an exception with regard to GLP and has been reflected in the GLP compliance statement.
Study Design

Using available information on the toxicity of the test item, 2000 mg/kg was chosen as the starting dose.


Doses:
Using available information on the toxicity of the test item, 2000 mg/kg was chosen as the starting dose.
A single animal was treated as follows:

Dose Level (mg/kg) Concentration (mg/mL) Dose Volume (mL/kg) Number of Rats (Female)

2000 200 10 1

In the absence of toxicity at a dose level of 2000 mg/kg, an additional group of animals was treated as follows:

Dose Level (mg/kg) Concentration (mg/mL) Dose Volume (mL/kg) Number of Rats (Female)

2000 200 10 4

A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
No. of animals per sex per dose:
A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study.
Control animals:
no
Details on study design:
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.

Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays.

Individual body weights were recorded on Day O (the day of dosing) and on Days 7 and 14.

At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The acute oral median lethal dose (LD5o) of the test item in the female Wistar strain rat was found to be greater than 2000 mg/kg body weight.
Mortality:
There were no deaths.
Clinical signs:
other: No signs of systemic toxicity were noted during the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be greater than 2000 mg/kg body weight.
Executive summary:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a solution in distilled water, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

 

Mortality. There were no deaths.

Clinical Observations. There were no signs of systemic toxicity. Body Weight. All animals showed expected gains in body weight. Necropsy. No abnormalities were noted at necropsy.

In conclution the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be greater than 2000 mg/kg body weight.