Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
UK Department of Health, 13 February 2003
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NExBTL Biodiesel
- Description: Clear colourless liquid
- Date received: 27 April 2005

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK)
- Age at study initiation: 8-12 wk
- Weight at study initiation: 210-243 g
- Fasting period before study: yes, overnight
- Housing: group, 3/cage
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 (lights on 0600-1800 hr)


IN-LIFE DATES: From: 26 May 2005 To: 16 June 2005

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- None used
Doses:
2000 mg/k bw
No. of animals per sex per dose:
2 groups of 3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight:

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No mortality or adverse effects
Mortality:
None
Clinical signs:
None
Body weight:
Weight gain as expected and not unaffected by treatment
Gross pathology:
None present
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 >2000 mg/kg bw
Executive summary:

Acute oral toxicity was determined in GLP compliant guideline study (acute toxic class method, method B1 of directive 2004/73/EC) using 6 young adult female Sprague Dawley rats (age 8-12 wk, bw 210-243 g). The test substance was administered neat as a single dose by gavage (2000 mg/kg bw) following an overnight fast, and the animals observed for 14 days post-treatment. Access to food recommenced 3-4 hr post-treatment. There were no deaths or any clinical signs noted following treatment and the animals gained weight normally. No gross abnormalities detected at on study day 14. The results demonstrate that the acute oral LD50 of NExBTL renewable diesel is greater than 2000 mg/kg bw.