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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 13 March 2019 to 28 March 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure

Test material

1
Reference substance name:
1,2-Benzenedicarboxylic acid, tridecyl ester, manuf. of, by-products from
EC Number:
271-080-4
EC Name:
1,2-Benzenedicarboxylic acid, tridecyl ester, manuf. of, by-products from
Cas Number:
68515-39-9
Molecular formula:
none available
IUPAC Name:
1,​2-​Benzenedicarboxylic acid, tridecyl ester, manuf. of, by-​products from

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS B.V. Inc., AD Horst, The Netherlands
- Age at study initiation: 7-8 weeks of age
- Weight at study initiation: females (135.6-164.6 g)
- Fasting period before study: overnight
- Housing: groups of 1 to 5 rats (of same sex and dose group)
- Diet (e.g. ad libitum): 2018C Teklad Global 18% protein Rodent diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 45-65
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Remarks:
The test item was formulated at a concentration of 200 mg/mL in the vehicle and administered at a constant dose volume of 10 mL/kg body weight.
Details on oral exposure:
Dose administration was once orally by gavage (feeding needle). The volume administered did not exceed 10 mL/kg b.w.
2000 mg/kg was chosen as the initial starting dose, since a severe toxicity which may necessitate humane euthanasia was not expected at this dose level.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 animals treated at dose level of 2000 mg/kg; all animals tested were female.
Control animals:
no
Details on study design:
- Duration of clinical observation period following administration: 0.5, 1, 2, and 4 hours after dosing and daily thereafter for 14 days.
- Mortality and morbidity checks were performed at least 3 times within the first 6 hours after application and daily thereafter for 14 days.
- Frequency of observations and weighing: Body weights were recorded on Day 0 (prior to dosing), Day 7, and 14
- Necropsy of survivors performed: yes
- Animals were killed by by carbon dioxide asphyxiation followed by cervical dislocation.
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
Evaluation of data includes the identification of the number of animals that died during the study (or that were killed for humane reasons), and determination of the nature, severity, onset and duration of the toxic effects. Effects on body weights and abnormalities noted at necropsy were identified. Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.

Results and discussion

Preliminary study:
A sighting study using one rat at the 2000 mg/kg dose level. In the absence of mortality or toxicity at a dose level of 2000 mg/kg, an additional group of 4 rats were dosed at 2000 mg/kg (n=5 total rats at 2000 mg/kg). There were no deaths during the study.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no deaths observed
Mortality:
No deaths observed.
Clinical signs:
Clinical signs at the 2000 mg/kg dose level were observed in one animal 1 day after dosing. were piloerection and underactivity. These signs were only noted very transiently, approximately two hours after dosing. No clinical signs were seen in the other animals.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities noted.
Other findings:
No other signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute oral median lethal dose (LD50) of the study substance in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System − Category 5).
Executive summary:

Acute oral toxicity of the study substance was assessed in the female Wistar strain rat.


 


Following a sighting test at a dose level 2000 mg/kg b.w. in one female rat, a further group of four fasted females was given a single oral dose of study substance, as a solution in corn oil, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored in all animals during the study. All animals were subjected to gross necropsy.


 


There were no deaths. Clinical observations of piloerection and decreased activity was noted transiently (after 2 hours of dosing only) in one animal (female no. 1). There were no signs of systemic toxicity noted in the remaining animals. All animals showed expected gains in body weight and no abnormalities were noted at necropsy.


 


From these results it can be concluded that the acute oral median lethal dose (LD50) of the study substance in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.

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