2-ethylhexyl 3,5,5-trimethylhexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-11-29 to -2017-02-22

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:

equivalent or similar to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl 3,5,5-trimethylhexanoate

EC Number:

275-073-7

EC Name:

2-ethylhexyl 3,5,5-trimethylhexanoate

Cas Number:

70969-70-9

Molecular formula:

C17H34O2

IUPAC Name:

2-ethylhexyl 3,5,5-trimethylhexanoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ORIENTBIO INC., Republic of Korea
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks old
- Weight at study initiation: 184.1-201.0 g
- Fasting period before study: Not given
- Housing: Stainless wire mesh cage, 260W×350D×210H (mm), one animal/cage (during the study)
- Diet (e.g. ad libitum): Pelleted rodent chow, (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C)
- Water (e.g. ad libitum): Public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum.
- Acclimation period: Yes. For 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Measurement value: 21.0-24.8°C; permissible range: 19.0-25.0°C
- Humidity (%): Measurement value: 47.9-62.9%; permissible range: 30.0-70.0%
- Air changes (per hr): 10-15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From 2016-12-9 To: 2017-02-22

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle (if gavage): 5mL/kg bodyweight
- Lot/batch no. (if required): 10700018
- Purity: 99.8

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance, 2,000 mg/kg was selected as the starting dose for this study based on the information supplied by the sponsor.

Doses:

2000 mg/kg

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 min, 1, 2, 4, 6 hours after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

Statistical analysis was not performed. Mean scores and values were determined.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths of animals at 2,000 mg/kg throughout the study.

Clinical signs:

other: No abnormalities of clinical signs were observed in any animal at 2,000 mg/kg throughout the study.

Gross pathology:

No grossly visible findings were observed in any animal at 2,000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on the result of the acute oral toxicity study in Sprague-Dawley rats (LD 50 cut off >=5000 mg/kg b.w., the test substance was considered Unclassified according to the GHS classification.

Executive summary:

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

Two dose groups of three females were utilized as follows:

Groups 1 and 2 (Steps 1 and 2): 2,000 mg/kg of the test substance

Steps 1-2: A dose of 2,000 mg/kg was administered to group 1 (Step 1) and then, as there was no mortality, a second dose of 2,000 mg/kg was administered to group 2 (Step 2).

All animals were monitored for clinical signs and body weight changes during the 14-day observation period, after which time they were subjected to a gross necropsy.

There were no mortalities in any animals following administration of 2,000 mg/kg and no test substance-related effects on clinical signs, body weight data or necropsy findings.

Based on the result of the acute oral toxicity study in Sprague-Dawley rats, the test substance, was not classified according to the GHS classification.