Fatty acids, C8-10-(even numberd), Esters with pentaerythritol and adipic acid

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 Sep - 02 Oct 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Behörde Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane

EC Number:

306-085-3

EC Name:

Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane

Cas Number:

95912-89-3

IUPAC Name:

95912-89-3

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Age at study initiation: 8 weeks (males), 9 weeks (females)
- Weight at study initiation: 243-260 g (males), 221-231 g (females)
- Fasting period before study: animals were fasted for approx. 16 h before administration.
- Housing: animals were kept by sex in groups of 2-3 animals in MAKROLON cages (type III plus), bedded with granulated textured wood (Granulat A2, J. Brandenburg, Goldenstedt, Germany).
- Diet: commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18 Sep 2012 To: 02 Oct 2012

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: dynamic inhalation chamber (RHEMA-LABORTECHNIK, Hofheim, Germany) with cylindrical exposure chamber
- Exposure chamber volume: 40 L
- Method of holding animals in test chamber: in pyrex tubes at the edge of the chamber in a radial position
- Source and rate of air: compressed air (5.0 bar) from a compressor at a flow rate of 900 L/h (entrance) and 800 L/h (exit)
- System of generating particulates/aerosols: spray-jet (Type 970, Düsen-Schlick GmbH, Untersiemau, Germany)
- Method of particle size determination: cascade impactor according to May
- Treatment of exhaust air: exhaust air was sucked through gas wash-bottles.
- Temperature, humidity, pressure in air chamber: 21.2° C, 61.5%

TEST ATMOSPHERE
- Brief description of analytical method used: the actual aerosol concentration in the inhalation chamber was measured 4 times gravimetrically with an air sample filter (Minisart SM 17598; 0.45 µm) and pump (Vacuubrand, MZ 2C ) controlled by a rotameter. Aerosol samples were taken once every hour during the exposure. For that purpose, a probe was placed close to the animals' noses in the inhalation chamber and air was sucked through the air sample filter at a constant flow of air of 5 L/min for 1 minute. The filters were weighed before and after sampling on an analytical balance.
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle: 21% v/v oxygen content in the air

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: see Table 1 under “Any other information on materials and methods incl. tables”
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 4.481 µm / 3.19

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetric

Duration of exposure:

4 h

Concentrations:

5.05 mg/mL (analytical concentration)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: examination of clinical signs and mortality were performed at least once daily. Body weights were determined before exposure on Day 1 and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Mean values and standard deviations of temperature, humidity and analytical concentration were calculated.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.05 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality was observed during the whole study period.

Clinical signs:

other: Slight ataxia, slight tremor and slight dyspnoea occurred immediately until 30 min or 3 h after end of exposure in all male and female animals.

Body weight:

No treatment-related body weight effects were seen and all animals showed the expected gain in body weight.

Gross pathology:

No pathological findings were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: not classified