Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 - 25 Aug 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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 Dec 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:

30 May 2008

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

yes (incl. QA statement)

Remarks:

OGYÉI, Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet, Budapest, Hungary

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs.

EC Number:

614-257-7

Cas Number:

68071-40-9

Molecular formula:

C18H34O4, C20H38O4 and C22H42O4 (mainly)

IUPAC Name:

Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs.

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, protected from light and humidity

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI rats

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: TOXI COOP ZRT., Budapest, Hungary
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 11 weeks
- Weight at study initiation:
group of 1st step: 242 g
group 2nd step: 245 - 253 g
- Fasting period before study: animals were fasted over-night before and 3 hours after treatment
- Housing: group caged (max. 3 animals per cage) in Type II polypropylene/polycarbonate cages with bedding
- Diet: ssniff® SM R/M-Z+H complete diet for rats and mice (ssniff Spezialdiäten GmbH, Soest, Germany),
- Water: tap water as for human consumption, from bottle, ad libitum
- Acclimation period: 27 days (group of 1st step) and 28 days (group of 2nd step)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): >10
- Photoperiod (hrs dark / hrs light): 12/ 12

IN-LIFE DATES:
group of 1st step: From: 09 To: 24 Aug 2016
group 2nd step: From: 10 To: 25 Aug 2016

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Helianthi Annui Oleum Raffinatum (sunflower oil)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: It is one of the standard vehicle for acute toxicity studies and it was selected on the basis of the trial forming.
- Lot/batch no.: 8001528001

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose was selected on basis of the available information about the test item. The acute toxic class method was carried out involving a stepwise procedure (according to OECD 423) with the use of 5000 mg/kg bw as the starting dose in one female rat (group of 1st step). Since this animal did not die, further dosing was proceeded at the same dose level in 2 additional females within a second step. As no mortality was noticed in the second step, no further testing was done.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

no

Remarks:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observation for mortality: at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after gavage and thereafter twice per day for 14 days
general observations: at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after gavage and thereafter daily for 14 days
weighing: on Day 0, 7 and on Day 15 (all groups)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, general state, external appearance, behavior, tissues and organs

Statistics:

No statistical analysis were performed.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: 1 of 2 animals showed several clinical symptoms on Day 1: decreased activity (1 cases of 38 observations), abnormal gait (1/38), incoordination (1/38), closed eyes (1/38), decreased body tone (1/38), piloerection (1/38) and decreased body temperature (1/3

Gross pathology:

No treatment-related pathological changes (oder abnormalities) were found.

In 1 of 2 animals severe hydrometra was observed. Hydrometra is a physiological finding connected to the cycle of female rats, and thus, not considered treatment-related.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs was evaluated in accordance to OECD 423 using female Wistar rats. The LD50 was identified as > 5000 mg/kg bw. Thus, no classification applies in acordance to CLP (Regulation (EC) No 1272/2008).

Executive summary:

The acute oral toxicity of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs was evaluated in accordance to OECD 423 using female Wistar rats. No mortality occurred during the study period. The LD50 was identified as > 5000 mg/kg bw. Thus, no classification applies in acordance to CLP (Regulation (EC) No 1272/2008).