Octanoic acid, 2-phenoxyethyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 Dec 2008 - 13 Jan 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

adopted in 2002

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-phenoxyethyl octanoate

EC Number:

607-240-0

Cas Number:

23511-73-1

Molecular formula:

C16H24O3

IUPAC Name:

2-phenoxyethyl octanoate

Test animals

Species:

rat

Strain:

other: Han Wistar Crl:WI

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females: nulliparous and non-pregnant
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: range: 168 - 181 g (300 mg/kg bw); 181 - 212 g (2000 mg/kg bw)
- Fasting period before study: animals were fasted overnight prior to and 3 - 4 h after dosing
- Housing: groups of 3 animals in Macrolon MIV cages, sterilized sawdust as bedding material (Litalabo, S,P.P,S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet: pelleted rodent diet (SM R/M-Z from Ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 33 - 69, except for 3 hours on one day with only 18%
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

3 females per dose level and per step

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was checked twice daily. Clinical signs were noted at 0, 2 and 4 hours on the day of dosing and once daily thereafter; animals were weighed prior to administration of the test substance and on Days 8 and 15
- Necropsy of survivors performed: yes
- Number of steps per dose: 2

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study period.

Clinical signs:

other: 300 mg/kg bw: hunched posture in all females of both steps and piloerection in all females of the first step occurred, all animals recovered on Day 2 to 3 post administration. 2000 mg/kg bw: lethargy and flat/hunched posture were observed in all females o

Gross pathology:

Necropsy revealed no substance-related findings.

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