Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 October 2008 - 22. December 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethoxycarbonylmethyl ethyl phthalate
EC Number:
201-555-3
EC Name:
Ethoxycarbonylmethyl ethyl phthalate
Cas Number:
84-72-0
Molecular formula:
C14H16O6
IUPAC Name:
ethyl 2-[(2-ethoxy-2-oxoethoxy)carbonyl]benzoate
Test material form:
liquid
Remarks:
clear, colourless, slightly viscous liquid
Details on test material:
Batch number: N-00103
Test material received: 01 September 2008

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- supplied by Harlan UK Limited, Bicester, Oxon, UK
- females were nulliparous and non-pregnant
- acclimatisation period of at least five days
- unique number, indelible ink-marking on the tail
- Age at start of the study: eight to twelve weeks of age
- bodyweight variation did not exceed ± 20% of the initial/mean boddyweight
- overnight fast before dosing and fast approx. three to four hours after dosing
- food and water ad libitum

HOUSING
- in groups up to four
- suspended solid-floor polypropylene cages furnished with woodflakes
- Temperature: 19-25°C
- Humidity: 30-70%
- Air exchange: at least fifteen changes per hour
- Light/Dark: 12/12 h

Diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose of integrity of the study.

FOOD
- 2014 Teklad Global Rodent diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Gavage: metal cannula attached to a graduated syringe
Volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Sighting test: one female
Main test: four females
Control animals:
no
Details on study design:
- Animals were dosed once only by gavage.
- Clinical observations were made 1/2, 1, 2 and 4 hours after dosing and once daily for fourteen days
- Morbidity and mortality checks twice daily
- Individual body weights recorded on day 0 (the day of dosing) and on days 7 and 14
- At the end of the observation period the animals were killed by cervical dislocation
- gross necropsy of all animals: external examination, opening of the abdominal and thoracic cavities

Results and discussion

Preliminary study:
- mortality: no deaths
- Clinical observation: no signs of systemic toxiicty
- Bodyweight: expected gains in bw over observation period
- Necropsy: no abnormalities were noted
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
Clinical observation: no signs of systemic toxiicty
Body weight:
expected gains in bw over observation period
Gross pathology:
no abnormalities were noted

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bw.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following OECD Guideline 420.

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

No animals died. No signs of systemic toxicity were observed. All animals showed expected gains in bodyweight. No abnormalties were noted at necropsy.

The acute oral median lethal dose (LD50) of the test material in the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bw.