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Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
dose selection is not appropriate

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 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Version / remarks:
adopted on 3rd October, 2008
Deviations:
yes
Remarks:
no limit test were completed
GLP compliance:
yes (incl. QA statement)
Limit test:
no

Test material

Constituent 1
Chemical structure
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:
male/female
Details on test animals or test system and environmental conditions:
Species Rattus norvegicus (rat)
Strain Wistar
Age 8 to 12 weeks
Weight Range (g)
(Start of experiment) 127.14 to 195.27
Sex Male & Female (nulliparous & non-pregnant)
Source Sainath agencies, Hyderabad, India.

This supplier is approved by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA), Government of India for breeding laboratory animals.
Number of animals 30 M & 30 F
No of groups 6

Administration / exposure

Route of administration:
oral: gavage
Details on route of administration:
Test item was formulated in sesame oil for dose preparation and administered by oral gavage.

Vehicle:
other: sesame oil
Duration of treatment / exposure:
The test item dose was administered to rats daily for a period of 28-days as given below:
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
25 mg/kg bw/day (nominal)
Dose / conc.:
50 mg/kg bw/day (nominal)
Dose / conc.:
100 mg/kg bw/day (nominal)
No. of animals per sex per dose:
The test item dose was administered to rats daily for a period of 28-days as given below:
Group No. No & Sex of animals Dose Route of Administration Dose Volume
G1 5 M + 5 F Control group: Sesame oil Oral 1 mL/100g b. w.
G2 5 M + 5 F Low dose: 25 mg/kg b.w. Oral 1 mL/100g b. w.
G3 5 M + 5 F Mid dose: 50 mg/kg b.w. Oral 1 mL/100g b. w.
G4 5 M + 5 F High dose: 100 mg/kg b.w.Oral 1 mL/100g b. w.
G5 5 M + 5 F Control group: Reversal Oral 1 mL/100g b. w.
G6 5 M + 5 F High dose: Reversal Oral 1 mL/100g b. w.
M, Male; F, Female

Weekly body weight of animals were taken; and appropriate dose volume was administered for the next week.
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
Mortality & Morbidity
All the animals were observed for mortality and morbidity throughout the study period.

Body Weight
Body weight of each animal was recorded immediately before dosing, weekly after the first dose and at the end of the study.

Feed and Water Consumption
Feed and water consumption was recorded daily throughout the experiment.

Clinical Observation
Clinical observations were made at least once in a day, throughout the study period, preferably at the same time of each day and recorded.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
None of the animals from any group showed any clinical signs of toxicity during the treatment.
Mortality:
no mortality observed
Description (incidence):
No morbidity & mortality was observed in any of the animals from the control and treatment group.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
All rats of the treated groups did not show statistically significant changes when compared to the vehicle control groups. Similar findings were observed in reversal groups.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
Feed and water consumption was recorded cage wise daily and reported on a weekly basis. There were no statistically significant changes observed in any of the groups.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
no effects observed
Description (incidence and severity):
Feed and water consumption was recorded cage wise daily and reported on a weekly basis. There were no statistically significant changes observed in any of the groups.
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Description (incidence and severity):
Hematology and Clinical Biochemistry
No statistical significant changes were observed in the treated groups when compared with the vehicle control groups.
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
Hematology and Clinical Biochemistry
No statistical significant changes were observed in the treated groups when compared with the vehicle control groups.
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
Organ Weights
No statistical significant changes in relative as well as absolute organ weights in any of the groups.
Gross pathological findings:
no effects observed
Description (incidence and severity):
Gross Pathology
Most tissues were macroscopically unremarkable and the findings seen were generally consistent with the usual pattern of findings in animals of this strain and age. There were no findings of an unusual nature. There were no macroscopic findings suggestive of effects of the test item.
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
Histopathology
Microscopic findings were generally infrequent, of a minor nature and consistent with the usual pattern of findings in animals of this strain and age. There were no microscopic findings in treated animals due to effects of the test item.
Histopathological findings: neoplastic:
no effects observed
Description (incidence and severity):
Histopathology
Microscopic findings were generally infrequent, of a minor nature and consistent with the usual pattern of findings in animals of this strain and age. There were no microscopic findings in treated animals due to effects of the test item.
Other effects:
not specified

Effect levels

Key result
Dose descriptor:
NOEL
Effect level:
> 100 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
clinical biochemistry
clinical signs
food consumption and compound intake
gross pathology
haematology
histopathology: neoplastic
histopathology: non-neoplastic
mortality
organ weights and organ / body weight ratios
water consumption and compound intake
Remarks on result:
not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
Based upon the results obtained in this study and in line with OECD 407: 2008 it is concluded that, the given test item, Allyl Amyl Glycolate, supplied by MORAYA GLOBAL LIMITED, did not produce any systemic toxicity following 28 days oral repeated dosing. The No-Observed Adverse Effect Level (NOAEL) value is greater than 100 mg/kg of bodyweight.
Executive summary:

Based upon the results obtained in this study and in line with OECD 407: 2008 it is concluded that, the given test item,AllylAmyl Glycolate, supplied byMORAYA GLOBAL LIMITED, did not produce any systemic toxicity following 28 days oral repeated dosing.The No-Observed Adverse Effect Level (NOAEL) value is greater than 100 mg/kg of bodyweight.

This study was performed to evaluate the toxicity profile, arising from a repeated dose of Allyl Amyl Glycolate, when administered by orally to rats for a period of 28 days.

Test item was freshly formulated in sesame oil for each day of dosing.

Sixty rats were randomly distributed into six groups (five males and five females (nulliparous and non-pregnant) per group; G1 - Control group: Sesame oil; G2 - Low dose: 25 mg/kg b.w.; G3 - Mid dose: 50 mg/kg b.w.; G4 - High dose: 100 mg/kg b.w.; G5 - Control group: Reversal; G6 - High dose: Reversal. Test item formulation was administered by oral gavage for 28 days. After 28 days, animals in group G5 and G6 were maintained for further 14 days without any test item treatment, for post treatment observation to find the reversibility of any observed effects and also to find out any delayed effects of the test item.

No mortality/morbidity or any clinical signs of toxicity was observed during the treatment period. Treated and control group of rats did not show statistically significant changes in body weight at different weeks. Feed and water consumption data did not show any statistically significant changes in any of the groups.

Haematology parameters (hematocrit, clotting time, hemoglobin concentration, red blood cell count, white blood cell count, WBC differential count and platelet count); biochemistry parameters (sodium, potassium, glucose, total cholesterol, urea nitrogen, creatinine, total protein, albumin, total bilirubin, alanine aminotransferase, aspartate aminotransferase data did not show statistically significant changes in various parameters in different groups. No test item related gross pathological changes were recorded. There were no statistically significant changes in organ weights.  There were no macroscopic or microscopic findings due to effects of the test item.

Based upon the results obtained in this study and in line with OECD 407: 2008 it is concluded that, the given test item,AllylAmyl Glycolate, supplied byMORAYA GLOBAL LIMITED, did not produce any systemic toxicity following 28 days oral repeated dosing.The No-Observed Adverse Effect Level (NOAEL) value is greater than 100 mg/kg of bodyweight.