Ethylene polymerisation (triethylaluminium catalysed), distillation residue, C20-40 fraction

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-06-12 to 2008-03-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was conducted according to OECD Guideline 420 and GLPs.

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)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C20-24

IUPAC Name:

Alkenes, C20-24

Details on test material:

- Name of test material (as cited in study report): ENORDET O241
- Physical state: Clear, colourless liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: not reported
- Fasting period before study: over night
- Housing: groups of up to four, suspended solid-floor polypropylene cages with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 degrees Celsius
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

IN-LIFE DATES: From: 2008-02-19 To: 2008-02-20

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 2.53 ml/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on available information on the toxicity of the test material

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 female rats

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 0 and on Days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, morbitity and mortality check were made twice daily.

Statistics:

None provided

Results and discussion

Preliminary study:

No toxicity was observed at a dose level of 2000 mg/kg, when tested by gavage, on one female rat.

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred

Clinical signs:

other: There were no signs of systemic toxicity

Gross pathology:

No abnormalities were noted at necropsy

Other findings:

none reported

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

In an acute oral toxicity study, 5 fasted female Sprague-Dawley CD strain rats were given a single oral dose of ENORDET O241 at dose of 2000 mg/kg bw and observed for 14 days. There were no treatment related clinical signs, necropsy findings or chantes in body weight. The oral LD50 was determined to be greater than 2000 mg/kg in females.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted according to OECD Guideline 420 and GLPs.