Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6th March 2014-24th April, 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

EC Number:

268-582-0

EC Name:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Cas Number:

68130-25-6

Molecular formula:

C10 H20 O2 . x C8 H16 O2 . x C8 H16 O2 . x C5 H12 O4

IUPAC Name:

Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate

Test material form:

liquid

Details on test material:

Name: ADEKA PROVER H-32
Chemical name: PENTAERYTHRITOL, 2-ETHYLHEXANOIC ACID, CAPRYLIC ACID, CAPRIC ACID MIXED ESTER
Lot No. 61893
CAS No. 68130-25-6
Appearance: Pale yellow liquid
Purity: 100%
Molecular formula: C(CH2OH)4 x C8H16O2 (2-ETHYLHEXANOIC ACID) x C10H20O2 x C8H16O2 (CAPRYLIC ACID)
Specific gravity: 0.97
Affinity: Hydrophobic, lipophilic
Stability: Stable in normal condition
Date of manufacture: Sep. 18, 2013
Expiration date: Sep. 18, 2015
Storage conditions: Normal temperature (20.8 to 21.7°C)
Date of receipt: Feb. 20, 2014
Residual test substance: The unused portion of the test substance was discarded after completion of the study.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ORIENTBIO INC., Korea
- Females (if applicable) nulliparous and non-pregnant: unknown
- Age at study initiation: 8 to 9 weeks old
- Weight at study initiation: 181.8 to 218.4 g
- Fasting period before study: Animals were fasted overnight, approximately 16 hours prior to dosing.
- Housing:Stainless wire mesh cage, 260W×350D×210H (mm)
- Diet (e.g. ad libitum): The feed was placed in feeders and provided ad libitum.
- Water (e.g. ad libitum):Public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 to 23.5°C
- Humidity (%): 44.5 to 62.0%
- Air changes (per hr): 10 to 15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: Day 1 To: Day 14

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): The required amount of the test substance was weighed using an electronic balance (CP323S, Sartorius, Germany) and placed in a bottle. A small amount of vehicle, corn oil, was added and mixed using a vortex mixer until dissolved. The vehicle was gradually added to yield the desired concentrations (60 and 400 mg/mL). All preparations were conducted just prior to use.
- Justification for choice of vehicle:
- Lot/batch no. (if required): MKBP7039V


MAXIMUM DOSE VOLUME APPLIED: 5ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The starting dose level for this study was selected at 300 mg/kg because there is no available toxicity information on the test substance.

Doses:

300mg/kg and 2000mg/kg

No. of animals per sex per dose:

3 animals per dose.

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs (time, onset, severity and recovery) at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days (Days 1 to 14). The body weights were recorded prior to dosing (Day 0), on Days 1, 3 and 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:Since no gross findings were evident at the necropsy, histopathological examinations were not performed.

Statistics:

Statistical analysis was 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:

All animals dosed at 300 and 2,000 mg/kg survived the duration of the study. There were no effects on the mortality.

Clinical signs:

other: No clinical abnormalities were evident in any animals dosed at 300 and 2,000 mg/kg.

Gross pathology:

No grossly visible evidence of morphologic abnormalities was evident in any animals dosed at 300 and 2,000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance, ADEKA PROVER H-32, was classified to be Category 5 or Unclassified according to the GHS classification.

Executive summary:

The purpose of this study was to assess the potential toxicity and to classify the test substance, ADEKA PROVER H-32, under the category of GHS classification following a single oral administration to female Sprague-Dawley rats.

Three dose groups of three females per group were utilized as follows:

Groups 1 and 2 (Steps 1 and 2): 300 mg/kg of the test substance

Groups 3 and 4 (Steps 3 and 4): 2,000 mg/kg of the test substance

Step 1: 300 mg/kg was administered. Then, there was no mortality (Step 1), and a second dose of 300 mg/kg was administered (Step 2).

Step 3: There was no mortality (Steps 1 and 2), and a third dose of 2,000 mg/kg was administered. Then, there was no mortality (Step 3) and a fourth dose of 2,000 mg/kg was administered (Step 4).

All animals were monitored for clinical signs and body weight changes during the 14-day observation period. They were subjected to gross necropsy at the end of the observation period.

There were no deaths of animals dosed at 300 and 2,000 mg/kg. No acute toxic effects were evident in clinical signs, body weight data or necropsy findings in any animals dosed at 300 and 2,000 mg/kg.

Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance, ADEKA PROVER H-32, was classified to be Category 5 or Unclassified according to the GHS classification.