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Acute Toxicity: oral

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acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:

Test animals

Details on test animals or test system and environmental conditions:
Species Wistar rats
Source Dobrá Voda, Slovak Republic
Number and Sex of Animals 6 females
Age at First Dose 9-10 weeks; female animals were non-pregnant and nulliparous
Animal Health Health condition of animals was examined by a veterinarian before initiation of the study.
Acclimation The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
Housing Condition The animals were housed in plastic cages suspended on stainless steel racks, 3 animals per cage in a room equipped with central air-conditioning. The average room temperature was maintained within the range of 22.09 ± 0.21 °C, relative humidity within 54.33 ± 2.34 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.
Diet The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time. The certificate of analysis is included in the raw data.
Water The animals received tap water for human consumption. Supply of drinking was unlimited. The quality of drinking water is periodical analysed and recorded; certificate of analysis is included in the raw data.
Bedding Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification The animals in the cage were marked by a line (I-III) on the tail with a waterproof marker. Each cage was marked with the study code, ID of animals and date of administration of the test item.
Justification for the Choice of Species Normally females are used for testing according to OECD TG 423 because females are typically the more sensitive gender.

Administration / exposure

Route of administration:
oral: gavage
olive oil
Details on oral exposure:
The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the test item administered. After test item administration, food was withheld for further 3-4 hours.
2000 mg/kg
No. of animals per sex per dose:
Control animals:

Results and discussion

Preliminary study:
A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose.
Effect levels
Key result
Dose descriptor:
other: Clinical Observation
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
No mortality was observed during the study.
Clinical signs:
No mortality was observed during the study. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction.
Body weight:
A stagnation of body weight in animal No 6 was observed. The body weights of the rest animals increased during the study. A stagnation of body weight in animal No 5 was observed between the first and second week after administration of the test item. Summary results of body weights are presented in Table 3.
Table 3 Body Weight
Sex Dose ID Body Weight (g) Body Weight Difference (g)
Initial Week 1 Week 2 Week 1 - Initial Week 2 - Initial Week 2 - Week 1
♀ 2000 mg/kg 1 178 187 194 9 16 7
2 166 180 186 14 20 6
3 164 185 192 21 28 7
4 188 195 209 7 21 14
5 189 203 203 14 14 0
6 191 191 191 0 0 0
Gross pathology:
The test item gamma-Dodecalactone administered to 6 females at a limit dose of 2000 mg/kg body weight did not caused death. No signs of toxicity were observed during the first 4 hours in females or the 14-day observation period thereafter. A stagnation of body weight in one animal was observed. The body weights of the rest animals increased during the study. During necropsy, no macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The LD50 of the test item is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item is according to UN Globally Harmonized System of Classification, Labelling and Packaging of Chemicals classified Category 5/Unclassified with a LD50 cut off value equal to or greater than 5000 mg/kg body weight according to Regulation (EU) Nr. 1272/2008 (CLP), after single oral administration to Wistar rats.

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