Naphtha (Fischer-Tropsch), light, C4-10-branched and linear

Acute Toxicity: oral

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

Reference substance name:

-

EC Number:

481-730-0

EC Name:

-

Cas Number:

848301-65-5

Molecular formula:

main general molecular formula: CnH(2n+2)

IUPAC Name:

C4-C10 branched and linear hydrocarbons (light) – Naphtha

Details on test material:

- Name of test material (as cited in study report): Naphtha (Fischer-Tropsch), light C4-C10 branched and linear
- Substance type: Organic
- Physical state: clear colourless liquid
- Analytical purity: Not stated in test report
- Impurities (identity and concentrations): Not stated in test report
- Composition of test material, percentage of components: Not stated in test report
- Purity test date: Not stated in test report
- Lot/batch No.: Not stated in test report
- Expiration date of the lot/batch: Not stated in test report
- Stability under test conditions: Not stated in test report
- Storage condition of test material: Not stated in test report

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% ofthe 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.
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
- Lot/batch no. (if required):
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 (or other?):
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, other:
yes

Statistics:

No statistical procedures were required.

Results and discussion

Preliminary study:

no clinical signs of toxicity

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Mortality: no deaths

Clinical signs:

other: Clinical observations: no signs of systemic toxicity

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	1	2	4	1	2	3	4	5	6	7	8	9	10	11	12	13	14
5000	Female 1 -0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5000	Female 2 -0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5000	Female 2 -1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5000	Female 2 -2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
5000	Female 2 -3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

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	207	235	268	28	33
5000	Female 2 -0	202	236	259	34	23
5000	Female 2 -1	206	239	263	33	24
5000	Female 2 -2	203	230	260	27	30
5000	Female 2 -3	211	238	253	27	15

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight --> the test material is of low toxicity via the oral route; using EU GHS, it is unclassified.

Executive summary:

An acute oral toxicity study with rats was performed according to OECD Guideline 420 (Fixed-dose method; adopted 2001) and Method B.1 of Commission Directive 2004/73/EC.

- Mortality: no deaths

- Clinical observations: no signs of systemic toxicity

- Body Weight: within expected gains

- Necropsy: no abnormalities

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.