Hydrocarbons, C16-C22, n-alkanes, isoalkanes, <2% aromatics

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

October 2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study on supporting substance (with limited range, C8-16). Read-across is considered to be reliability 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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:

481-670-5

EC Name:

-

IUPAC Name:

481-670-5

Constituent 2

Reference substance name:

848301-66-6

Cas Number:

848301-66-6

IUPAC Name:

848301-66-6

Constituent 3

Reference substance name:

Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear

IUPAC Name:

Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear

Constituent 4

Reference substance name:

C8-C16 branched and linear hydrocarbons (full range) – Kerosine

IUPAC Name:

C8-C16 branched and linear hydrocarbons (full range) – Kerosine

Details on test material:

- Name of test material (as cited in study report): Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear
- Substance type: Organic
- Physical state: 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) supplied by BCM IPS Limited, London, UK) 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
- 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
- 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 required.

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:

No mortality

Clinical signs:

other: No signs of systemic toxicity were noted.

Gross pathology:

No abnormalities were noted at necropsy.

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	201	231	256	30	25
5000	Female 2 -0	200	229	237	29	8
5000	Female 2 -1	203	237	257	34	20
5000	Female 2 -2	208	240	260	32	20
5000	Female 2 -3	208	220	240	12	20

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: other: 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’.

Conclusions:

The acute oral median lethal dose (LD50) of the related substance 'Kerosine (Fischer-Tropsch), full range, C8-16 - 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 and hence, the related substance 'Distillates (Fischer-Tropsch), full range, C8-26 - branched and linear' should be also of low toxicity.
Using the EU Globally Harmonised System (GHS), the substance 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:

The related substance 'Kerosines (Fischer-Tropsch), C8 -16 branched and linear' was tested in an acute oral toxicity study according to the fixed dose method (OECD 420 or EU method B.1). 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. Finally, the acute oral median lethal dosage (LD₅₀) of the substance 'Distillates (Fischer-Tropsch), C8 -26 - branched and linear` should also be greater than 5000 mg/kg bw.