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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2006-10-03 to 2006-10-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP-study according to relevant guideline. Read-across considered to be reliability 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

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 (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
481-740-5
EC Name:
-
Cas Number:
848301-67-7
Molecular formula:
main general molecular formula: CnH(2n+2)
IUPAC Name:
C8-C26 branched and linear hydrocarbons – Distillates
Details on test material:
- Name of test material (as cited in study report): Distillates (Fischer-Tropsch), C8-26 branched and linear
- Substance type: Organic
- Physical state: Clear colorless liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Information not available
- Composition of test material, percentage of components: Information not available
- Isomers composition: Information not available
- Purity test date: Information not available
- Lot/batch No.: Information not available
- Expiration date of the lot/batch: Information not available
- Stability under test conditions: Stable under normal temperature and pressure
- Storage condition of test material: Room temperature, in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: At the start of the study the animals were eight to twelve weeks of age.
- Weight at study initiation: The bodyweights fell within an interval of i 20% of the initial bodyweight of the first treated animal.
- Fasting period before study: With the exception of an overnight fast immediately before dosing and for approximately three to four hours after
dosing, free access to mains drinking water and food (Certified Rat and Mouse Diet (Code SLF2) was allowed throughout the study.
- Housing: On receipt the animals were randomly allocated to cages.
- Diet (e.g. ad libitum): Overnight fast immediately before dosing and for approximately three to four hours after dosing (free access to mains
drinking water and food was allowed throughout the study).
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): The temperature was set to achieve limits of 19 to 25°C.
- Humidity (%): The relative humidity was set to achieve limits of 30 to 70%.
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Not applicable
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not applicable
- Purity: Not applicable

MAXIMUM DOSE VOLUME APPLIED:
5000 mg/kg

DOSAGE PREPARATION (if unusual):
Not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not applicable
Doses:
5000 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: Day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology: yes
Statistics:
No statistical procedures were applied.

Results and discussion

Preliminary study:
Following a preliminary test in which there were no deaths at a dose level of 5000 mg/kg, an additional 4 fasted Sprague-Dawley DC rats received a dose of 5000 mg of the undiluted test material per kg body weight by gavage.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
- Mortality: no deaths
Clinical signs:
- Clinical observations: no signs of systemic toxicity
Body weight:
- Body Weight: within expected gains
Gross pathology:
- Necropsy: no abnormalities
Other findings:
None

Any other information on results incl. tables

Table 1: Individual Clinical Observations and Mortality Data

Dose level  Animal  Effects noted after dosing (hours)                    Effects noted during period after dosing (days)                                  
(mg/kg)   No.  0,5 10  11  12  13  14 
5000  Female 1 -0   0 0
5000   Female 2 -0  
5000    Female 2 -1  0
5000    Female 2 -2   0  0
5000    Female 2 -3  0  0  0  0  0  0  0  0  0  0  0 0

0- No signs of systemic toxicity

Table 2: Individual Body weights and Bodyweight changes

Dose level  Animal        Bodyweight at day (g)     Body weight gain during week (g)
(mg/kg)   No.  Day 0 Day 7  Day 14  Day 1  Day 7 
5000  Female 1 -0  213 247 268  34  21
5000    Female 2 -0   190  213  216  23
5000  Female 2 -1  216  251  273 35  22 
5000    Female 2 -2   198 236 249 36 15
5000    Female 2 -3  206 229 238 23 9

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight. Using the EU Globally Harmonised System (GHS), it would be ‘unclassified’. However, since the substance is composed of aliphatic
hydrocarbons and has low viscosity, it may present an aspiration hazard in humans following oral exposure. It is therefore appropriate to classify
the substance as ‘Harmful: may cause lung damage if swallowed’.
Executive summary:

'Distillates (Fischer-Tropsch), C8-26 branched and linear' was tested in an acute oral toxicity study according to the fixed dose method (OECD 420). Following a preliminary test in which there were no deaths at a dose level of 5000 mg/kg, an additional 4 fasted Sprague-Dawley DC rats received a dose of 5000 mg of the undiluted test material per kg body weight by gavage. There were no signs of toxicity, all animals showed normal gains in body weight, and there were no abnormalities on necropsy. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight.