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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
daily mean relative humidity but the study integrity was not adversely affected
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
daily mean relative humidity but the study integrity was not adversely affected
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-octyldodecyl 5-oxo-L-prolinate
EC Number:
253-604-3
EC Name:
2-octyldodecyl 5-oxo-L-prolinate
Cas Number:
37673-37-3
Molecular formula:
C25H47NO3
IUPAC Name:
2-octyldodecyl 5-oxo-L-prolinate
Test material form:
other: liquid
Details on test material:
- Test substance: 2-octyldodecyl 5-oxo-L-prolinate
- ZS Name: Pyroglutaminsaureoctyldodecylester
- ZS Number: 1856
- Batch number: 192955 01
- Appearance: liquid
Specific details on test material used for the study:
Batch no.: CH 192955/01
Purity/composition: 99.98%
Appearance: clear yellow liquid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl:WI (Han)
Sex:
female
Details on test animals or test system and environmental conditions:
Source: Charles River Deutschland, Sulzfeld, Germany
Age: approx. 8 weeks old
Acclimatization period: at least 5 days before start of treatment
Temperature and relative humidity: 18 to 24°C and 40 to 70%, respectively.
Light period cycle: 12-hour light/12-hour dark
Diet and water: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) and tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
Method: oral gavage, using plastic feeding tubes. The test substance preparations were stirred on a magnetic stirrer during dosing.
Fasting: animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
Frequency: single dosage on Day 1.
Doses:
2000 mg/kg bw (10 mL/kg bw)
No. of animals per sex per dose:
3 (2 consecutive groups)
Control animals:
no
Details on study design:
The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
Statistics:
No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred.
Clinical signs:
Piloerection or uncoordinated movements were noted for all animals on Day 1 only.
Body weight:
The mean body weight gain shown by the animals over the study period was considered to be normal.
Gross pathology:
Abnormalities of the thymus (several purple foci) were found in one animal at macroscopic examination.

Any other information on results incl. tables

The oral LD50 (rats) was established to exceed 2000 mg/kg bw. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg bw. Based on these results, the test substance does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Based on these results, the test substance does not have to be classified
Conclusions:
Under the study conditions, the rat oral LD50 for the test substance was established to exceed 2000 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the test substance according to OECD Guideline 423 and EPA OPPTS 870.1100 (acute toxic class method), in compliance with GLP. The test substance was administered by gavage to two consecutive groups of three female Wistar rats at a concentration of 2000 mg/kg bw. Animals were subjected to daily observations and weekly determinations of body weight. Macroscopic examination was performed after terminal sacrifice on Day 15. No mortality occurred. Piloerection or uncoordinated movements were noted for all animals on Day 1 only. The mean body weight gain over the study period was considered to be normal. Finally, Abnormalities of the thymus (several purple foci) were found in one animal at macroscopic examination. Under the study conditions, the rat oral LD50 for the test substance was established to exceed 2000 mg/kg bw (Latour, 2016).

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