2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Sep - 12 Oct 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Slovenska Narodna Akreditacna Sluzba, Bratislava, Slovak Republic

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate

EC Number:

283-393-3

EC Name:

2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate

Cas Number:

84608-82-2

Molecular formula:

C26H45NO6

IUPAC Name:

2-hydroxy-3-(oleoyloxy)propyl 5-oxo-L-prolinate

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: MAT- Consulting, Slovak Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 170 - 190 g (range)
- Fasting period before study: animals were fasted overnight until 3-4 h after administration
- Housing: up to 3 animals per cage in plastic cages suspended on stainless steel racks, on Lignocel S3/4 bedding (Lufa - ITL GmbH, Germany)
- Diet: ssniff (Ssniff Spezialdiäten GmbH, Germany), at recommended doses
- Water: public tap water, ad libitum ; analysis was performed
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.39 ± 0.2
- Humidity (%): 54.44 ± 1.89
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 21 Sep - 12 Oct

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Lot no.: L63417

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 2000 mg/kg bw as available information indicated that the test substance is likely to be non-toxic with regard to acute toxicity. As no mortality was observed during 24 h, in a second step, another 3 females were treated at the same dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females per step (6 in total)

Control animals:

no

Remarks:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at 30 min after dosing and at 1, 2, 4 h after dosing on Day 0 and once daily thereafter for 14 days
- Frequency of weighing: prior to dosing on Day 0 and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (including potential neurologic endpoints)

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: No clinical signs were observed during the study period.

Gross pathology:

No grossly visible findings were observed.

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:

CLP: not classified