Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 April 2012 - 17 may 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the OECD 420 guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Constituent 1
Reference substance name:
Renewable hydrocarbons (diesel type fraction)
EC Number:
700-916-7
Molecular formula:
UVCB substance, not available. View remarks field.
IUPAC Name:
Renewable hydrocarbons (diesel type fraction)
Details on test material:
- Name of test material (as cited in study report): Diesel
- Substance type: UVCB substance
- Physical state: liquid
- Analytical purity: 100%; UVCB substance
- Lot/batch No.: 11-09149-001
- Expiration date of the lot/batch: 01 January 2013
- Storage condition of test material: room temparature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 155-167 g
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: at least five days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Using available information on the toxicity of the test item, one animal was gavaged at a dose level of 2000 mg/kg. In the absence of toxicity, an additional group of animals (four) were gavaged at 2000 mg/kg bw. All animals were dosed once using metal cannula attached to a graduated syringe. The 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:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Preliminary study:
2000 mg/kg bw was chosen as the starting dose, no mortality was observed.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths (See table 1)
Clinical signs:
No signs of systemic toxicity were noted (See table 1)
Body weight:
All animals showed expected gains in bodyweight over the observation period (See table 2)
Gross pathology:
No abnormalities were noted at necropsy (See table 3)
Other findings:
- Organ weights: not measured
- Histopathology: not examined
- Potential target organs: not observed
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The acute oral medial lethal dose (LD50) of the test item in the female rat was estimated to be greater than 2000 mg/kg bodyweight.
Executive summary:

The objective of this study was to assess the toxicity of the test item when administered in a single oral dose (2000 mg/kg bw) to female rats. No mortalities were observed at the tested dose level.

The study is considered reliable without restrictions since the study is carried out based on the OECD No. 420 guideline and in compliance with principles of Good Laboratory Paractice (GLP).

Based on these results, the test item does not have to be classified and has no obligatory labeling requirement for acute oral toxicity according to CLP Regulation 1272/2008 and Directive 67/548/EEC.