[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:

2018

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:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

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:

Reaction product of adipic acid and neodecanoic acid, 2-​oxiranylmethyl ester (C31H56O10)+(C32H58O10)+(C33H60O10)

Molecular formula:

C32H58O10

IUPAC Name:

Reaction product of adipic acid and neodecanoic acid, 2-​oxiranylmethyl ester (C31H56O10)+(C32H58O10)+(C33H60O10)

Constituent 2

Reference substance name:

not yet assigned

Molecular formula:

C50H88O16 C51H90O16 C52H92O16

IUPAC Name:

not yet assigned

Constituent 3

Reference substance name:

2,3-epoxypropyl neodecanoate

EC Number:

247-979-2

EC Name:

2,3-epoxypropyl neodecanoate

Cas Number:

26761-45-5

Molecular formula:

C13H24O3

IUPAC Name:

(oxiran-2-yl)methyl 2,2-dimethyloctanoate

Test material form:

liquid: viscous

Details on test material:

Former EC 615-318-0 / CAS: 716336-43-5: changed to EC 825-846-5 / CAS 876528-25-5

Test animals

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 178-195 g
- Housing: 3 animals per cage
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10 °C
- Photoperiod (hrs dark / hrs light): 12h rhythm

IN-LIFE DATES: From: To: 25 May 2018 to 20 JUNE 2018

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The liquid test item was used as supplied. The administration volume was 1.89 mL/kg b.w. as the density was determined to be 1.06 g/mL.

No test item-formulation analysis had to be carried out as the dose level of 2000 mg/kg b.w. was used as supplied. As no animal died prematurely at this dose level, no test item-formulation had to be prepared.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All animals were observed for a period of 14 days.
During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on prematurely deceased animals were made at least once daily to minimize loss of animals during the study. The time of death would have been recorded as precisely as possible. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
At the end of the experiments, all animals were sacrificed, dissected and inspected macroscopically. All gross pathological changes were recorded.

Statistics:

No statistical analysis could be performed (the method used is not intended to allow a calculation of a precise LD50 value).

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 deaths

Clinical signs:

other: Treatment resulted in slightly to moderately reduced motility, slight to moderate ataxia, slightly reduced muscle tone and slight dyspnoea in 6 of 6 animals as well as pilo-erection in 5 of 6 animals and abdominal position in 2 animals between 60 minutes

Gross pathology:

no findings

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The acute oral LD50 in rats is determined with >2000 mg/kg bw based on the results of a limit dose study performed according to OECD TG 423. The test dose of 2000 mg/kg resulted in clinical signs as slightly to moderately reduced motility and ataxia, slight dyspnoea, pilo-erection and abdominal position between 60 minutes and 6 hours after administration. No clinical signs were observed from test day 2 until the end of the study. All animals gained the expected body weight and no gross pathological findings were recorded.