[No public or meaningful name is available]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Nov - 22 Dec 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

adopted in 2008

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

adopted in 2002

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese MAFF

Version / remarks:

adopted in 2000

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2-bis[(hexadecanoyloxy)methyl]propane-1,3-diyl dihexadecanoate

Cas Number:

18641-58-2

Molecular formula:

C69H132O8

IUPAC Name:

2,2-bis[(hexadecanoyloxy)methyl]propane-1,3-diyl dihexadecanoate

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl: WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approx. 9 weeks
- Weight at study initiation: 164 - 191 g
- Fasting period before study: The animals were deprived of food overnight (for a maximum of 20 h) prior to dosing and until 3 - 4 h after dosing. Water was constantly available.
- Housing: In groups of 3/sex in polycarbonate cages (Makrolon type MV, height 18 cm) with sterilised wooden fibers as bedding and paper for enrichment.
- Diet: Pelleted rodent diet sMR/MZ (Ssniff Spezialdiäten GmbH, Soest, Germany) ad libitum
- Water: Municipal tap water, ad libitum
- Acclimation period: at least 5 days
- Microbiological status when known : SPF

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 20
- Humidity (%): 50 - 61
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 30 Nov - 22 Dec 2020

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Trial preparations were performed to select the suitable vehicle and to establish a suitable formulation procedure. These trials were not performed as part of this study and these preparations were not used for dosing.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females per step per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed twice daily for general health, moribundity and mortality.
- Frequency of weighing: on Day 1, 8 and 15
- Necropsy of survivors performed: yes. All animals were subjected to necropsy and all internal macroscopic abnormalities were recorded.

Statistics:

Statistical analysis was not performed.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Hunched posture, erected fur and slight to moderate uncoordinated movements were noted for all animals between Days 1 - 3. The animals were free of any clinical signs thereafter.

Body weight:

other body weight observations

Remarks:

The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain.

Gross pathology:

Necropsy and pathological examination revealed no abnormal findings.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

The substance was tested for acute oral toxicity in female rats according to OECD guideline 423 and compliant with GLP, at a dose level of 2000 mg/kg bw. No mortality occured and the resulting LD50 value was > 2000 mg/kg bw.