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Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 June 2013 - 21 August 2013
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
see below
according to guideline
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
The study was performed in accordance with study plan No. 40080 TAR and subsequent amendments, with the following deviations from the agreed study plan:
. expiry date was updated based on a new certificate of analysis, . the solubility assay was performed in corn oil before being tested in 0.5% methylcellulose aqueous solution,
. for group 3 animals, food was given on day 1 but was not documented in the raw data,
. the observation of clinical signs on day 6 for female B22987 (group 3) was performed but not recorded in the study files.
These deviations were considered not to have compromised the validity or integrity of the study.
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methyl-1,5-pentanediyl diacrylate
EC Number:
EC Name:
3-methyl-1,5-pentanediyl diacrylate
Cas Number:
Molecular formula:
3-methyl-5-(prop-2-enoyloxy)pentyl prop-2-enoate

Test animals

Details on test animals or test system and environmental conditions:
- Source: breeder: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: approximately 8 weeks old on the day of treatment.
- Mean body weight at study initiation: 177 g to 201 g.
- Fasting period before study: yes, overnight before treatment.
- Housing: the animals were housed by three from the same group in polycarbonate cages.
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study

- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: 02 July 2013 to 31 July 2013

Administration / exposure

Route of administration:
oral: gavage
corn oil
Details on oral exposure:
- Concentration in vehicle: 200 mg/mL
- Maximum dose-volume applied: 10 mL/kg

DOSAGE PREPARATION (if unusual): the test item was administered as an emulsion in the vehicle. The test item was mixed with the required quantity of vehicle.
Dose formulations preparations were prepared by the CiToxLAB France Pharmacy extemporaneously on the day of each administration.
The dose formulations were stored at room temperature and delivered to the study room in brown flasks.

CLASS METHOD (if applicable):
- Rationale for the selection of the starting dose: the starting dose-level was selected in agreement with the Sponsor, based on the following rationale: since no relevant toxicity data were available for the estimation of a lethal dose-level and any existing data were taken into account by the Sponsor, the starting dose-level was 300 mg/kg for animal welfare reasons.
After treatment at the starting dose-level, the next dose-levels were administered in a sequential manner, under the same conditions to different animals, based on the dose-levels indicated in the flow charts of OECD Guideline No. 423, 17th December 2001, which are equivalent to those of Commission Regulation (EC) No. 440/2008, B.1tris (30 May 2008).
300 mg/kg, and 2000 mg/kg
No. of animals per sex per dose:
300 mg/kg : 3 females
2000 mg/kg: 3 females + 3 females
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Clinical observations: frequently during the hours following treatment; then, at least once a day.
- Body weight: just before treatment on day 1; then on days 8 and 15.
- Necropsy of survivors performed: yes (macroscopic).

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No unscheduled deaths occurred during the study.

Clinical signs:
other: Hunched posture along with piloerection were observed on day 1 from 1 hour to 4 hour post-dose and were no longer observed by day 2 for 3/6 animals at 2000 mg/kg, while 3/6 animals exhibited hunched posture only on day 2. No clinical signs were observed
Gross pathology:
There were no macroscopic findings at necropsy.

Other findings:

Any other information on results incl. tables

 Table 1




Historical control data




Dose-level (mg/kg)





Body weight (mean (± SD))





. Day 1

208 (± 11.7)

198 (± 5.8)

181 (± 5.5)

187 (± 10.1)

. Day 8

246 (± 12.7)

230 (± 1.2)

210 (± 10.0)

219 (± 10.5)

. Day 15

266 (± 14.0)

253 (± 3.0)

233 (± 22.6)

242 (± 17.0)

Body weight change (mean (± SD))





. Days 1-8

+39 (± 5.1)

33 (± 4.6)

30 (± 6.1)

31 (± 1.0)

. Days 8-15

+20 (± 6.3)

23 (± 2.5)

23 (± 14.2)

23 (± 10.1)

. Days 1-15

+58 (± 5.8)

55 (± 3.5)

53 (± 17.8)

55 (± 10.6)

SD: Standard Deviations.


Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The oral LD50 of the test item was higher than 2000 mg/kg in rats.

Executive summary:

The objective of this study was to evaluate the potential acute toxicity of the test item following a single oral administration (gavage) to rats. This study was conducted in compliance with OECD Guideline No. 423 and the principles of Good Laboratory Practice.

The test item was administered once by oral route (gavage) to three groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was prepared in corn oil.

Since no relevant toxicity data were available for the estimation of a lethal dose-level and any existing data have been taken into account by the Sponsor, the starting dose-level was 300 mg/kg for animal welfare reasons. After the first assay, the next higher dose-level of 2000 mg/kg was tested. Then, as no toxicity was observed at this higher dose-level, the results were confirmed in other females.

Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on day 1 and then on days 8 and 15.

On completion of the observation period, the animals were sacrificed and then submitted to a macroscopic post-mortem examination. No tissues were preserved.

No unscheduled deaths occurred during the study and there were no test item-related effects on body weight. At 300 mg/kg, no clinical signs were observed. At 2000 mg/kg, on day 1 and/or 2, hunched posture was observed for all animals, while piloerection was observed on 3/6 animals. These clinical signs were no longer observed by day 2 or 3.There were no macroscopic findings at necropsy.

The oral LD50 of the test item was higher than 2000 mg/kg in rats.