Allyl phenoxyacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June - July 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No information on purity was given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

No information on purity was given.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Allyl phenoxyacetate

EC Number:

231-335-2

EC Name:

Allyl phenoxyacetate

Cas Number:

7493-74-5

Molecular formula:

C11H12O3

IUPAC Name:

allyl phenoxyacetate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 109 - 117 g (males), 103 - 116 g (females)
- Fasting period before study: overnight prior to dosing
- Housing: individually in solid-bottom polypropylene boxes, softwood sawdust was used as bedding material
- Diet: R 4 Alleindiät für Ratten (Ssniff Versuchstier-GmbH, Soest, Germany), ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 40% alcohol pure in polyethyleneglycol 200 (v/v)

Details on oral exposure:

A range-finding study was carried out to establish a dosing regimen for the main study.

VEHICLE
- Concentration in vehicle: range-finding study: 25, 50, 200 and 500 mg/mL; main study: 50, 63, 79.4 and 100 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

Range-finding study: 250, 500, 2000 and 5000 mg/kg bw
Main study: 500, 630, 794 and 1000 mg/kg bw

No. of animals per sex per dose:

Range-finding study: 2 males and 2 females
Main study: 5 males and 5 females

Control animals:

no

Details on study design:

Range-finding study:
- Duration of observation period following administration: 7 days
- Frequency of observations: Animals were observed daily during the 7 day period following treatment. Individual body weights were recorded on the day of treatment.
- Necropsy of survivors performed: no

Main study:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 15 and 30 min and 1, 2 and 4 h after administration and subsequently at least once daily for 14 days. Individual body weights were determined on the day before treatment (Day -1), on the day of treatment (Day 0), at death and again 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

The acute oral median lethal dose LD50 and 95% fiducial limits for combined male and female animals were calculated using probit method (Finney, D.J. (1964), Statistical Methods for Biological Assay, 2nd Edition, London, Charles Griffin).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

835 mg/kg bw

Based on:

test mat.

95% CL:

> 716 - < 974

Mortality:

Range-finding study: All animals died at 2000 and 5000 mg/kg bw. No mortality was observed at 250 and 500 mg/kg bw. The mortalities indicated a LD50 in the range of 500 - 2000 mg/kg bw.

Main study: Three males and four females died at 1000 mg/kg bw, one male and 3 females at 794 mg/kg bw and 3 males at 630 mg/kg bw. With exception of one animal which died on Day 4 after treatment, all animals were found dead 4 h up to 2 days after treatment. No mortality occurred at 500 mg/kg bw.

Clinical signs:

other: The majority of animals showed lacrimation, piloerection, hunched position, oscillated movements and shaggy coat following treatment in all dose level groups. Other occasional signs of intoxication were lethargy at 630 mg/kg bw and higher, eyes half close

Gross pathology:

Sacrificed animals:
Thickened areas covering partially the mucosal surface of the forestomach and adhesions:
a) between forestomach and liver
b) between forestomach, liver and spleen
c) between forestomach, liver, spleen and peritoneum

Dead animals:
Macroscopic findings were mainly associated with the gastrointestinal tract. The following toxic abnormalities were observed:
Stomach overloaded, severe reddening of the forestomach, red patches on mucosal surface of corpus and anteum of stomach. Moderate until severe congestion in liver, presence of bloody fluid in thorax and rounded spot of blood on the surface of thyme.
Additional observations were noted in one animal that died 4 days after treatment: false membrane, thickness and red patches in the mucosal surface of the forestomach, slight adhesion between forestomach and spleen and loamy-coloured liver.

Any other information on results incl. tables

Table 1. Results of the acute toxicity study.

Dose level (mg/kg bw)	Mortalities
	Male	Female
500	0/5	0/5
630	3/5	0/5
794	1/5	3/5
1000	3/5	4/5

Applicant's summary and conclusion

Interpretation of results:

other: Acute Tox. Cat. 4 according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study a LD50 value of 835 mg/kg bw in male and female rats was calculated according to the method of Finney (1963).