Ethyl 2-methylbutyrate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 April to 20 May 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Source and target substance are analogues.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
[Provide here, if relevant, additional information to that included in the Test material section of the source and target records]

3. ANALOGUE APPROACH JUSTIFICATION
[Summarise here based on available experimental data how these results verify that the read-across is justified]

4. DATA MATRIX

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl 2-methylpentanoate

Cas Number:

39255-32-8

IUPAC Name:

Ethyl 2-methylpentanoate

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Manzanate, DL 4979/F4-24.
- Physical state: clear, colourless, slightly viscous liquid
- Other:
- A sample of the test material was received from the sponsor on August 14, 1986.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: H3-G-26
- Expiration date of the lot/batch: 25 July 2014
- Purity test date:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored in original container at 2 to 8°C in the dark.
- Stability under test conditions: Stable

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Commercila laboratory animal supplier.
- Females non-pregnant: yes
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: male; 285 to 303g; female;199 to 204g
- Fasting period before study: no data
- Housing: Propylene rat cages
- Diet:ad libitum
- Water: ad libitum
- Acclimation period: 7days plus 2 hours in rat restrainer tubes.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22°C
- Humidity (%): 64 to 65%
- Air changes (per hr): 15 changes/hr
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark.

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

>= 1 - <= 4 µm

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: head/nose only
- Exposure chamber volume: 63.5l
- Method of holding animals in test chamber: exposure tubes
- Source and rate of air: 15 air changes/hr
- Method of conditioning air: maintaining negative pressure in exposure tube
- System of generating particulates/aerosols: a spray atomiser was used.
- Method of particle size determination:
- Treatment of exhaust air: Passed through 1.0% sodium hydroxide solution and moisture traps containing silica gel.
- Temperature, humidity, pressure in air chamber: 22.4 to 22.6°C. R.H. 43.7 to 44.4%

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric concentration analysis.
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution:
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: hourly during 4h exposure and at 1 and 2h after the exposure
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.967 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

None

Clinical signs:

other: None

Body weight:

Equalled or increased

Gross pathology:

No problems reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

This substance was found to be not classified for inhalation toxicity under CLP.