Allyl (3-methylbutoxy)acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

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:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Allyl (3-methylbutoxy)acetate

EC Number:

266-803-5

EC Name:

Allyl (3-methylbutoxy)acetate

Cas Number:

67634-00-8

Molecular formula:

C10H18O3

IUPAC Name:

allyl (3-methylbutoxy)acetate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Doses:

300 mg/Kg body and 2000 mg/Kg body

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

Test Procedure
A stepwise procedure using 3 female animals per step was used to assess the acute oral toxicity of the test item as described in the OECD guidelines for testing of chemicals, number 423.
In the lack of information about the toxicity of test item, a starting dose of 300 mg/Kg body weight was selected for Step 1. The test procedure was followed as per the attached scheme described in Appendix 1.
All the animals received a single dose of the test item by oral route of administration. Animals were administered with test item after being fasted for 15 h, but with ad libitum water. Feed was given after 3 h and 50 min following administration of test item.
A dose volume of 10 mL/Kg body weight was used. Based on the outcomes of the previous step, further steps were carried out.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

ca. 500 mg/kg bw

Based on:

test mat.

Mortality:

Mortality and Morbidity
In step 1 and step 2 all the animals were observed for mortality and morbidity for a period of 14 days following the test item administration. Based on mortality and morbidity rate observed at step 1 and step 2, the next steps were started based on the scientific judgement of the Study Director. In step 3 all animals were found dead following the test item administration.

Clinical signs:

Clinical Observation
Clinical observations were performed to look for signs of ill health or overt toxicity during the first 30 minutes and at 1, 2, 3 and 4 h after dose administration on Day 0 and daily during days 1-14 for step 1 and step 2. In step 3 clinical signs were observed at first 30 minutes and at 1, 2, 3 and 4 h after dose administration.
Any abnormalities of appearance or behaviour or other signs of reaction to treatment or ill health were recorded and a detailed individual record was maintained of the clinical condition of each animal.
Observations for signs of toxicity such as changes in skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems; and somatomotor activity and behaviour pattern were observed. Attention was also directed to observe for tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
No animals were found in a moribund condition and showed severe pain or enduring signs of severe distress in step 1 and step 2. In step 3 all animals were found dead after test item administration.

Body weight:

Body Weight
Body weight of each animal were recorded prior to the test item administration (day 0) and on day 7 and day 14 for step 1 and step 2.

Gross pathology:

Necropsy
All the animals in step 1 and step 2 were sacrificed by CO2 exposure at the end of the 14 days observation period and subjected to gross pathology.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral cut-off LD50 value in Wistar rats was 500 mg/kg/b.w. It is classifed as H302

Executive summary:

Acute oral toxicity potential of the test itemAllyl Amyl Glycolate(Batch No. AAG-TEST 1), supplied byMORAYA GLOBAL LIMITED, was evaluated in a 3-step procedure using 3 female (nulliparous and non-pregnant) Wistar rats for each step.

To administer a constant volume over the range of doses to the animal, solvent solubility trail was performed. The test item was not soluble in distilled water & physiological saline but was soluble inDMSO (Dimethyl sulfoxide) & sesame oil, therefore, desired concentration was achieved by mixing the test item with sesame oil.

In step 3 (2000 mg/kg b.w), toxicity symptoms were exhibited immediately after administration of test item. Animals showed signs like dyspnoea (difficult to breathing), abdominal breathing (breathing by diaphragm observed by greater deflection of abdomen), gasping (wheezing sound), nasal discharges, catatonia (decrease in spontaneous motor activities) and piloerection (rough hair standing up) during 30 mins observation. Between 1 h to 4 h, all animals exhibited tachycardia (increase in heart rate) and tucked up abdomen. At the end of 4^thh, all animals were dead (100% mortality). Necropsy revealed severe congestion in liver, kidney and lungs.

Based on the results obtainedin this study and in line withOECD Guideline for Testing of Chemicals, 423 (Adopted on 17^thDecember 2001) it is concludedthatthe given test itemAllylAmyl Glycolate(Batch No. AAG-TEST 1),supplied byMORAYA GLOBAL LIMITED,falls under ‘Category 4’ according to the Globally Harmonized System (GHS) for the classification of chemicals. The acute oralcut-offLD₅₀value in Wistar rats is 500 mg/kg/b.w.