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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-08-28 to 2008-11-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline Study Report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropenyl acetate
EC Number:
203-562-7
EC Name:
Isopropenyl acetate
Cas Number:
108-22-5
Molecular formula:
C5H8O2
IUPAC Name:
isopropenyl acetate
Details on test material:
Name: Isopropenyl acetate
Cas no.: 108-22-5
Purpose: industrial chemical
Colour: colourless
Physical state: liquid
Chemical name: 1-Propen-2-ol, acetate
Storage conditions: at room temperature, protected from light
Stability in solution or suspension: water: hydrolysis possible

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Species: Healthy rats (Full-Barrier)
Strain: HsdRccHan : WIST
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
Sex: female, non-pregnant, nulliparous
Age at the beginning of the study: 8 - 12 weeks old
Number of animals: 3 per step
Body weight at the beginning of the study:
Animals no 1 – 3, step 1: 167 - 184 g; Animals no 4 – 6, step 2: 147 – 156 g;
Semi-barrier in an air conditioned room
Body temperature: 22 ± 3 °C
Rel. humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice
Free access to tap water, sulphur acidulated to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiologically controlled at frequent intervals)
The animals were kept in IVC cages, type III H, polysulfone cages on Altromin saw fiber bedding
Certificates of food, water and bedding are filed at BSL Bioservice
Adequate acclimatization period (at least 5 days)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sodium chloride, NaCl 0.9%
Details on oral exposure:
For animal no. 1 of the first step, 1 g of the test item was dissolved in the vehicle ad 5 mL to gain a dosis of 2000 mg/kg body weight at a volume of 10 mL/kg body weight.
For animals no. 2 and 3 of the first step, 2 g of the test item were dissolved in the vehicle ad 10 mL to gain a dosis of 2000 mg/kg body weight at a volume of 10 mL/kg body weight.
For animals no. 4, 5 and 6 of the second step, 2 g of the test item were dissolved in the vehicle ad 10 mL to gain a dosis of 2000 mg/kg body weight at a volume of 10 mL/kg body weight.
The test substance was finely ground and a suspension made prior to administration and stirred throughout dose administration to guarantee stability and homogeneity. The vehicle was chosen due to its non-toxic characteristics.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
3 females per step
Control animals:
no
Details on study design:
The test item was administered as a single dose by gavage using an intubation cannula.
The test item was administered at a volume of 10 mL/kg body weight. The starting dose was selected to be 2000 mg/kg body weight. No compound related mortality was recorded for any animal of step 1 nor of step 2. Based on these results and according to the acute toxic class method regime no further testing was required.
Statistics:
not reported

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: none
Mortality:
not observed
Clinical signs:
Signs of toxicity related to dose level used, time of onset and duration:
Animal no. 1, step 1 (2000 mg/kg bw):
45 min post-dose: slightly reduced spontaneous reaction, piloerection, arched back
3 h 15 min post-dose: slightly reduced spontaneous reaction, piloerection
1 day post-dose until the end of the observation period: no signs of toxicity
Animal no. 2, step 1 (2000 mg/kg bw):
10 min post-dose: slightly reduced spontaneous reaction
1 day post-dose until the end of the observation period: no signs of toxicity
Animal no. 3, step 1 (2000 mg/kg bw):
10 min post-dose: slightly reduced spontaneous reaction, piloerection, arched back
1 day post-dose until the end of the observation period: no signs of toxicity
In the animals of the decond step, no signs of toxicity were observed.
Body weight:
No treatment related effects were recorded in any of the animals.
Gross pathology:
No treatment related effects were recorded in any of the animals.
Other findings:
none reported

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance has an LD50 of > 5000 mg/kg bw.
Executive summary:

6 female HsdRccHan : WIST rats (Full-Barrier) were administered with a dose of 2000 mg/kg bw according to OECD guideline 423. 0.9% sodium chloride served as a vehicle. It was chosen due to its non-toxic characteristics. After the administration the animals of the first stap showed slight signs of toxicity such as slightly reduced spontaneous reaction, piloerection and arched back. These effects were not seen one day after exposure or later. No treatment related effects on organs or body weight gain were recorded in any of the animals.Under the conditions of the present study it can be stated that the test item Isopropenyl acetate showed slightly acute oral toxic characteristics. The oral LD50 cut-off was determined to be 5000 mg test item /kg body weight due to only slight signs of toxicity. According to GHS (Globally Harmonized Classification System) the test item Isopropenyl acetate was not classified.