Octanoic acid, 2-phenoxyethyl ester

Endpoint summary

Description of key information

Acute toxicity, oral (OECD 423), female rats: LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 2002

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in 2008

Deviations:

no

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

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

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

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.

Interpretation of results:

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

Conclusions:

CLP: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable (RL1) key study. The information is therefore sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The Acute toxicity potential of 2-phenoxyethyl octanoate was tested in Crl:WI (Han) Wistar rats according to OECD guideline 423 and under GLP conditions (Notox, 2009). The starting dose administered by gavage to three female rats was 300 mg/kg bw. In a stepwise procedure additional groups of 3 females were dosed at 300, 2000 and 2000 mg/kg bw. No mortality occurred in any of the dose groups. 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. At 2000 mg/kg bw lethargy and flat/hunched posture were observed in all females of both steps and uncoordinated movements occurred in 2/3 females of both steps. Laboured respiration was observed in 1/3 females of the first step. Piloerection was noted in 2/3 and 3/3 females of the first and second step, respectively. Ptosis and/or hypothermia occurred in 1/3 females each step. All animals recovered latest on Day 3 post administration. The mean body weight gain shown by the animals over the study period was considered to be average for this strain and species. No abnormalities were found at macroscopic post mortem examination of the animals. In conclusion, the oral LD50 value of 2-phenoxyethyl octanoate in female Wistar rats was established to exceed 2000 mg/kg bw. The LD50 cut-off value was considered to be 5000 mg/kg bw according to OECD guideline 423.

Justification for classification or non-classification

The available data on acute oral toxicity with 2-phenoxyethyl octanoate do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.