Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A study according to the EU and OECD methods, including GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Common name: sodium phenoxyacetate
CAS No: 3598-16-1
Purity (dry basis): 99.83 %
Appearance: off white powder
Conditions of storage: Room temperature, no light protection
Stability at conditions of storage: Stable
Batch No: 30031722 or WE 30031722
Date of expiry: 13 January 2011
Supplier: Sandoz GmbH

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland.
- Age at study initiation: Ca. 8 w.
- Weight at study initiation: 181 - 205 g
- Fasting period before study: From the evening before dosing to 3 h after dosing.
- Housing: Single caging
- Diet: SNIFF R/M-H ad libitum
- Water: Tap water ad libitum
- Acclimation period:At least 7 d.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20.0
- Humidity (%): 30 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
A peroral administration was performed once in the morning by stomach intubation using a metal gavage.
The dose volume was 10 mL per kg body weight. The individual dose volumes were calculated using the body weights determined on the day of the administration.
Doses:
300 and 2000 mg/kg bw. See below.
No. of animals per sex per dose:
3 rats per step.
Control animals:
no
Details on study design:
The sequence of dosing of the test substance was:
Step 1: 300 mg/kg bw.
Step 2: 300 mg mg/kg bw.
Step 3: 2000 mg/kg bw.
Step 4: 2000 mg/kg bw.
Statistics:
No.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Mortality: All animals survived until the scheduled termination of the study.
Clinical signs:
Observations in life: All animals did not show any clinical signs during the entire observation period.
Body weight:
Body weights: All animals gained weight in both weeks p.a.
Gross pathology:
Necropsy findings: No abnormal findings were made in all animals at the necropsy 14 d p.a.

Any other information on results incl. tables

No toxic effects of the test substance were noted by signs in life and post mortem at a dose of 2000 mg test substance per kg body weight. No mortality occurred.

As no animals died, the LD50, oral was determined to be > 2000 mg/kg body weight. Based on the guidance given in OECD guideline 423 (annex 2c), the LD50, oral can be assessed to be > 5000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No toxic effects of the test substance were noted by signs in life and post mortem at a dose of 2000 mg test substance per kg body weight.The LD50 is >5000 mg/kg body weight.
Executive summary:

The acute toxic class (ATC) method according to the EU- and OECD-guidelines was applied to investigate the acute oral toxicity of sodium phenoxyacetate in rats.

No toxic effects of the test substance were noted by signs in life and post mortem at a dose of 2000 mg test substance per kg body weight. No mortality occurred. As no animals died, the oral LD50 was determined to be > 2000 mg/kg body weight. Based on the guidance given in OECD guideline 423 (annex 2c), the oral LD50 can be assessed to be > 5000 mg/kg body weight.