Decanedioic acid, compound with ethanolamine / Decanedioic acid, compound with 2-aminoethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 February 2017 - 02 March 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

2002

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

2008

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)

Version / remarks:

2000

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sebacic acid, compound with 2-aminoethanol (1:2)

Molecular formula:

C10H18O4.2(C2H7NO)

IUPAC Name:

Sebacic acid, compound with 2-aminoethanol (1:2)

Test material form:

solid: particulate/powder

Details on test material:

Physical appearance: Off-white to pale yellow powder
Storage conditions: At room temperature

Specific details on test material used for the study:

- Correction factor: 1.136
- Stability at higher temperatures: not stable; maximum temperature is 25°C
- Solubility in vehicle (water): fully
- Stability in vehicle (water): stable

Test animals

Species:

rat

Strain:

other: Crl: WI(Han)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Animals: 6 young adult females (nulliparous and non-pregnant) of approximately 8 weeks old
- Weight at study initiation: 148-167 g
- Fasting period before study: Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item. Water was available.
- Housing: up to 5 animals of the same sex and same dosing group were housed together in polycarbonate cages (Makrolon MIV type; height 18 cm.) containing sterilized sawdust as bedding material equipped with water bottles. For psychological/environmental enrichment, animals were provided with paper, except when interrupted by study prcedures/activities.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures.
- Water: municipal tap-water was available ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 21°C
- Humidity (%): 40-49
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 14 February 2017 - 02 March 2017

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

- Justification for choice of vehicle: Trial preparations were performed at the Test Facility to select the suitable vehicle and to establish a suitable formulation procedure. The vehicle is accepted by international guidelines.
- Test item dosing formulations (w/w) were homogenized to visually acceptable levels at appropriate concentrations to meet dose level requirements. The dosing formulations were stirred until and during dosing.
- A single dose of test item was administered to the appropriate animals by oral gavage on Day 1, using a syringe with a plastic gavage cannula attached.
- Justification for dose level: max. recommended dose based on OECD guideline 423.

Doses:

2000 mg test item (10 mL) /kg bodyweight

No. of animals per sex per dose:

3 females/group

Control animals:

no

Details on study design:

- Method: The test was performed in a stepwise treatment of 3 females, starting with a dose level of 2000 mg/kg bw. Based on the results, an additional group was dosed at 2000 mg/kg bw.
- Duration of observation period following administration: 14 days
- Frequency of observations:
Mortality and moribundity: twice daily
Weighing: individually on day 1, day 8 and day 15.
Other examinations: post dose observations, at least three times on the day of dosing and once daily thereafter.
- Necropsy: yes, all moribund animals and animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded.

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.

Mortality:

No mortality occurred.

Clinical signs:

other: Hunched posture, piloerection and/or ptosis were noted for all animals on Days 1 and/or 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Any other information on results incl. tables

The results were evaluated according to:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments).

- Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of items and mixtures (including all amendments).

According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified according to Regulation 1272/2008/EC

Conclusions:

The oral LD50 of Sebacic MEA salt was established in an acute oral toxicity study in rats (Acute Toxic Class Method), to exceed 2000 mg/kg bw. Based on these results, Sebacic MEA salt does not have to be classified and has no obligatory labelling requirement for acute oral toxicity under GHS and under Regulation 1272/2008/EC.

Executive summary:

The oral LD50 of Sebacic MEA salt was established in an acute oral toxicity study in rats (Acute Toxic Class Method), to exceed 2000 mg/kg bw. Based on these results, Sebacic MEA salt does not have to be classified and has no obligatory labelling requirement for acute oral toxicity under GHS and under Regulation 1272/2008/EC.N

OTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.