3-methyl-1,3-butanediol-1-ethylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-01-14 to 2016-02-10 (experiment start-end)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

(2001)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-1,3-butanediol-1-ethylate

EC Number:

816-856-0

Cas Number:

5205-01-6

Molecular formula:

C7H14O3

IUPAC Name:

3-methyl-1,3-butanediol-1-ethylate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material: Kuraray Co. Ltd. IPDA-63313
- Expiration date of the lot/batch: 30 March 2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, in the dark under nitrogen
- Stability under test conditions: not stated
- Solubility and stability of the test substance in the solvent/vehicle: not stated

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: one dose formulation prepared at 30 mg/mL. To achieve a 200 mg/mL dose, the test article was used as supplied
- Final preparation of a solid: n/a

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 wks
- Weight at study initiation:
- Fasting period before dosing: overnight, followed by 3-4 h post dosing
- Housing: gp housed (up to 4/cage)
- Diet (e.g. ad libitum): 2014 Teklad Global Rodent diet, ad libitum
- Water (e.g. ad libitum): municpal water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 14 January 2016 to 10 February 2016

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 mg/mL
- Amount of vehicle (if gavage): dose volume 10 mL
- Justification for choice of vehicle: suitable vehicle for oral gavage studies
- Lot/batch no. (if required): not stated
- Purity: n/a

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: a starting dose of 300 mg/kg bw was used in the sighting study as recommended by the OECD TG 420

Doses:

300 mg/kg bw
2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg bw: 1 females
2000 mg/kg bw: 5 females

Control animals:

no

Details on study design:

The test article was dissolved in water and administered to a single female fasted Wistar rat/dose level by oral gavage at a dose levels of 300 or 2000 mg/kg bw in an initial sighting study. Animals dosed at 2000 mg/kg bw received the test article as supplied by the Sponsor, without vehicle. A further four female rats were dose orally via gavage at 2000 mg/kg bw, employing a dose volume of 10 mL/kg bw. The observation period was 14 d post dosing, with gross pathology undertaken for all animals.

Statistics:

None

Results and discussion

Preliminary study:

A sighting study was undertaken, where a single female rat was dosed, orally via gavage at 300 mg/kg bw.
No mortality, or signs of clinical toxicity were observed.
The single animal treated showed expected body weight gains over the observation period.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No signs of clinical toxicity were observed

Gross pathology:

No macroscopic changes were observed

Other findings:

Histopathology and organ weights not undertaken

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw. Therefore, according to Annex I for Regulation (EC) 1272/2008 the formulation has no obligatory labelling requirement for acute oral toxicity and is unclassified.

Executive summary:

Animals selected for the study were randomised by weight and group allocated. The method used to investigate the acute oral toxicity of 3 -methyl-1,3 -butanediol acetate was the acute oral fixed procedure (OECD 420 (2001)), conducted under GLP.The test article was dissolved in water and administered to a single female fasted Wistar rat/dose level by oral gavage at a dose levels of 300 or 2000 mg/kg bw in an initial sighting study. Animals dosed at 2000 mg/kg bw received the test article as supplied by the Sponsor, without vehicle. A further four female rats were dose orally via gavage at 2000 mg/kg bw, employing a dose volume of 10 mL/kg bw. The observation period was 14 d post dosing, with gross pathology undertaken for all animals.

No clinical signs of toxicity or mortality were observed in rats in the sighting or main study. Body weight gain of these animals was normal. No treatment related gross pathological findings were noted in the animals.

Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw. Therefore, according to Annex I for Regulation (EC) 1272/2008 the formulation has no obligatory labelling requirement for acute oral toxicity and is unclassified.