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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Oral LD50 (rat) > 5840 mg/Kg bw

Inhalation LC50 (rat) > 25200 mg/m³

Dermal LD50 (rat) > 2800 -3100 mg/Kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Principles of method if other than guideline:
standard acute oral test
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent
- Age at study initiation: approx. 12 weeks
- Fasting period before study: on night before test
- Housing: 4 animals of one sex in a cage
- Diet (e.g. ad libitum): ad libitum after dosing
- Water (e.g. ad libitum): ad libitum after dosing
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
1, 2, 4, and 8 mL/kg bw
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Duration of observation period following administration: 9 days
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 mL/kg bw
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 8 mL/kg bw
Mortality:
No mortality occurred in any test animal over the 9-day observation period.

Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw

Interpretation of results:
other: Not Classified
Remarks:
Criteria used for interpretation of results: EU, GHS
Conclusions:
The purpose of this study was to determine the acute oral toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Two male and two female rats were exposed to 1, 2, 4, or 8 mL/kg of undiluted test substance orally. The animals were then observed for the next 9 days for mortality. No animals of either sex died during the study. The LD50 is > 8 mL/kg for both male and female rats. Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw. The test substance is not classified according to OECD GHS guidelines.
Executive summary:

The purpose of this study was to determine the acute oral toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics. Two male and two female rats were exposed to 1, 2, 4, or 8 mL/kg of undiluted test substance orally. The animals were then observed for the next 9 days for mortality. No animals of either sex died during the study. The LD50 is > 8 mL/kg for both male and female rats. Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw. The test substance is not classified according to OECD GHS guidelines.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 5 840 mg/kg bw
Quality of whole database:
One key read across study from structural analogue available for assessment.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 Sep 1987 - 22 Sep 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Principles of method if other than guideline:
Group of rats were exposed to test substance vapour for four hours and LC50 was determined.
GLP compliance:
not specified
Test type:
fixed concentration procedure
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Limited
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 200 g
- Housing: polypropylene cages (38x56x18 cm)
- Diet: free access to a measured excess amount of food
- Water (ad libitum): tap water



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±0.8 - 25±1.3
- Humidity (%): 61±6.6

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: vapour generator plus exposure chamber
- Exposure chamber volume: 120 L
- Method of holding animals in test chamber: wire mesh compartments
- Source and rate of air: supply of clean dried air was connected to the generator and the supply pressure was adjusted to give a flow rate of 25 L per minute
- Temperature in air chamber: 25±0.33-25.9 °C


TEST ATMOSPHERE
- Brief description of analytical method used: analysed with a gas chromatograph. Samples were drawn through a gas absorption trap, containing 20 ml of acetone and cooled to -70 °C. Sampling rate was 2 litres/minute and the volume of air sample was measured with a wet-type gas meter.
- Samples taken from breathing zone: yes


Analytical verification of test atmosphere concentrations:
yes
Remarks:
Pye Unicam PU 4550 fitted with a flame ionisation detector. Pye Unicam PU 4700 autosampler.
Duration of exposure:
ca. 4 h
Concentrations:
25.2 mg/L air
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs at least twice daily, body weight daily, food and water consumption daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 25.2 mg/L air
Exp. duration:
4 h
Mortality:
There were no deaths during the study.
Clinical signs:
other: restless behavior and increase in respiration rate during the first 15 minutes; partial closing of the eyes
Body weight:
no effects
Gross pathology:
The lung weight to bodyweight ratio for all rats was considered to be within normal limits. No other macroscopic abnormalities were observed.
Other findings:
Food consumption was slightly reduced for 1 day following exposure. Water consumption was not affected by exposure.
Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of the study a 4 hour LC50 >25.2 mg/L air was determined for the test substance, hydrocarbons, C6-C7, n-alkanes, Isoalkanes, cyclics < 5% hexane.
Executive summary:

Under the conditions of the study a 4 hour LC50 >25.2 mg/L air was determined for the test substance, hydrocarbons, C6-C7, n-alkanes, Isoalkanes, cyclics, < 5% n-hexane.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
> 25 200 mg/m³ air
Quality of whole database:
One substance specific key study available for assessment.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Principles of method if other than guideline:
The acute toxicity of SBP 100/140 was determined according to Noakes and Sanderson (1969): A method for determining the dermal toxicity of pesticides, Br. J. Industr Med 26: 59-64.
GLP compliance:
no
Test type:
other: according to Noakes and Sanderson (1969), Br. J. Industr Med 26: 59-64
Species:
rat
Strain:
other: Charles River CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
1, 2, 4 mL/kg
No. of animals per sex per dose:
2
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 4 mL/kg bw
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 800 - 3 100 mg/kg bw
Remarks on result:
other: Recalculated values based on the LD50 of 3.16 mL/kg bw; the range of LD50 is due to the range of density 0.71 -0.78 g/cm3.
Mortality:
none
Clinical signs:
other: none

Table: Mortality

Dose ml/kg

Males

Female

Total

1

0/2

0/2

0/4

2

0/2

0/2

0/4

4

0/2

0/2

0/4

Interpretation of results:
other: Not Classified
Remarks:
Criteria used for interpretation of results: other: CLP
Conclusions:
The dermal toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics was examined. Groups of two female and two male rats were exposed dermally to 1, 2, or 4 mL/kg of test substance. No animals died during the experiment. The dermal LD50 for rats is >= 4 mL/kg. The test substance is not classified as a dermal toxic under OECD GHS guidelines.
Executive summary:

The dermal toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics was examined. Groups of two female and two male rats were exposed dermally to 1, 2, or 4 mL/kg of test substance. No animals died during the experiment. The dermal LD50 for rats is >= 4 mL/kg. The test substance is not classified as a dermal toxic under OECD GHS guidelines.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 800 - < 3 100 mg/kg bw
Quality of whole database:
One key read across study from structural analogue available for assessment.

Additional information

There is one substance specific acute inhalation data available for Hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane. Additionally, data is available for structural analogue, Hydrocarbons, C7 -C9, n-alkanes, isoalkanes, cyclics and is presented in the dossier. This data is read across to Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

 

Acute Oral Toxicity

Hydrocarbons, C7 -C9, n-alkanes, isoalkanes, cyclics

In a key study (Shell, 1977) the acute oral toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics was determined. Two male and two female rats were exposed to 1, 2, 4, or 8 mL/kg of undiluted test substance orally. The animals were then observed for the next 9 days for mortality. No animals of either sex died during the study. The LD50 is > 8 mL/kg for both male and female rats. Based on the density given in the study report, the LD50 is calculated to approx. >5840 mg/kg bw. The test substance is not classified according to OECD GHS guidelines.

 

Acute lnhalation Toxicity

Hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% hexane

In a key study (Sell, 1988), the acute inhalation toxicity of hydrocarbons, C6 -C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane was deteremined. Five male and five female rats were exposed to the test substance for 4 hours. Clinical signs, bodyweight, food and water consumption were recorded at least once daily. Necropsy of survivors was performed. Under the conditions of the study a 4 hour LC50 >25.2 mg/L air was determined for the test substance, hydrocarbons, C6-C7, n-alkanes, Isoalkanes, cyclics, < 5% n-hexane.

 

Acute Dermal Toxicity

 

Hydrocarbons, C7 -C9, n-alkanes, isoalkanes, cyclics

In a key study (Shell, 1977), dermal toxicity of hydrocarbons, C7-C9, n-alkanes, isoalkanes, cyclics was examined. Groups of two female and two male rats were exposed dermally to 1, 2, or 4 mL/kg of test substance. No animals died during the experiment. The dermal LD50 for rats is >= 4 mL/kg. The test substance is not classified as a dermal toxic under OECD GHS guidelines.

 

Justification for classification or non-classification

Based on available substance specific and read across data, Hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane is minimally toxic via ingestion where the LD50 is >5840 mg/kg, via dermal exposure where the LD50 is >2800 -3100 mg/kg, and by inhalation where the LC50 >25200 mg/m3. These findings are conclusive but not sufficient for classification. However, acute exposure may result in non-lethal narcotic effects and the substance is therefore classified as STOT-SE Category 3 for narcosis effects under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Hydrocarbons, C6-C7, n-alkanes, isoalkanes, cyclics, <5% n-hexane is classified under EU CLP guidelines as a Category 1 aspiration hazard based on its physical and chemical properties (hydrocarbon fluid, viscosity ≤ 20.5 mm2/s).