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

Endpoint summary

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).