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Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17 Dec 2001
Deviations:
no
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
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
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
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.
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.
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Value:
5 000 mg/kg bw
Quality of whole database:
One acute oral toxicity study available performed in accordance to OECD and GLP criteria with reliability score of 1.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

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).