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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 10, 2016 - March 30, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
performed in compliance with GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Adopted: 17th December 2001
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:
2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate)
EC Number:
262-334-5
EC Name:
2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate)
Cas Number:
60623-04-3
Molecular formula:
C69H132O8
IUPAC Name:
3-[(2-hexyldecanoyl)oxy]-2,2-bis({[(2-hexyldecanoyl)oxy]methyl})propyl 2-hexyldecanoate
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Isocarb Ester 1605
- Substance type: Product
- Physical state: liquid
- Lot/batch No.: 03792 or 04549/MA
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 04549/MA
- Expiration date of the lot/batch: 15.05.2018
- Purity test date: not given

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Velaz Prague, Czech Republic
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 180 - 190 g
- Fasting period before study: yes, overnight
- Housing: in plastic cages suspended on stainless steel racks, up to 3 animals per cage
- Diet: laboratory food Altromin (Altromin Spezialfutter GmbH, Germany), offered in recommended doses each day approximately at the same time
- Water: tap water for human consumption ad libitum, quality of drinking water is periodical analysed (including microbiological control) and recorded
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): not mentioned, room equipped with central air conditioning
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March 15, 2016 To: March, 30, 2016

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: Oil is a standard vehicle according to OECD TG 423
- Lot/batch no. (if required): OC14019842, Galvex
- Purity: not stated

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: available information on similar tested compound indicated that the test item is likely to be nontoxic considering to acute toxicity, therefore a limit dose of 2000 mg/kg was used as a starting dose
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Individual weights of animals were determined shortly before the test item was administered and weekly thereafter.
- Necropsy of survivors performed: All test animals were subjected to gross necropsy.
- Other examinations performed: clinical signs (observations included changes in skin and fur, eyes and mucous membranes, respiratory,circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern, observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma), body weights (weight differences after first and second weeks after administration were calculated and recorded), gross pathological changes (full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents)
Statistics:
not performed

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed during the study.
Clinical signs:
other: Animals lived through observation period without signs of intoxication. Neither change of health nor negative reactions were registered.
Gross pathology:
During necropsy, no macroscopically changes were noticed.
Other findings:
none

Any other information on results incl. tables

Table: 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 1 190 220 230 30 40 10
2 180 210 220 30 40 10
3 190 210 210 20 20 0
4 190 220 230 30 40 10
5 180 200 220 20 40 20
6 190 220 230 30 40 10

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 of the test item 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Executive summary:

The purpose of the study was to evaluate the potential toxic effect of the test item 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate) when administered as a single oral dose to Wistar rats.

The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg was used as a starting dose. Two groups of 3 females were dosed. All 6 females survived the limit dose. The limit dose of 2000 mg/kg did not cause death, evident signs of toxicity or body weight loss during the 14-day long observation period. Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg of OECD Guideline 423 it can be concluded that the LD50 of the test item 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3 - propanediyl bis(2-hexyldecanoate) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.