Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich

Endpoint summary

Description of key information

Acute Oral LD₅₀ (Rat) > 16750 mg/kg bw

Acute Inhalation LC₅₀ (Rat) >259534 mg/m³

Acute Dermal LD₅₀ (Rabbit) > 3350 mg/kg

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

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable, well-documented publication that closely follows OECD Guideline 401.

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Long-Evans

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-300 g

Route of administration:

oral: gavage

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 25 ml/kg

Doses:

up to 25 ml/kg

No. of animals per sex per dose:

6 males

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

Litchfield and Wilcoxen.

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 25 mL/kg bw

Remarks on result:

other: 16.75 g/kg

Mortality:

No mortality at doses up to 25 ml/kg (16.75 g/kg (density 0.67)).

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for rats is > 25 ml/kg.

Executive summary:

This study examined the oral toxicity of commercial hexane. 6 male rats were given doses of up to 25 ml/kg of test substance by oral gavage. The animals were then observed for 14 days for mortality. No mortality was observed at any of the doses. The oral LD50 is therefore > 25 ml/kg (16.75 g/kg; density of 0.67).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 16 750 mg/kg bw

Quality of whole database:

One key read across study from a structural analogue available for assessment.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

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

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable, well-documented publication that closely follows OECD Guideline 403.

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Species:

rat

Strain:

Long-Evans

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 150-300 g

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 250 l
- Method of conditioning air: Sample was heated in a water bath at 77 degree F. Air was bubbled through the sample and entered the exposure chamber. For concentrations less than saturation, air flow was divided with part passing over the sample and part passing directly into the exposure chamber.

TEST ATMOSPHERE
- Brief description of analytical method used: GLC

Duration of exposure:

4 h

Concentrations:

73,680 ppm (30-40% of saturation at 25 degree C)
81,800 ppm

No. of animals per sex per dose:

10 males

Details on study design:

- Duration of observation period following administration: at least 6 days

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

73 860 ppm

Exp. duration:

4 h

Remarks on result:

other: 259354 mg/m3

Mortality:

All deaths occurred during exposure, except one rat in the 81800 ppm group that died on day 6.

Clinical signs:

other: Surviving rats were uncoordinated, prostrate or comatose during exposure but recovered within a few hours of removal from the chamber. The rat that died on day 6 had convulsions during and after exposure.

Interpretation of results:

study cannot be used for classification

Conclusions:

The 4-hr LC50 for rats exposed by inhalation was 73,680 ppm.

Executive summary:

This study examined that acute inhalation toxicity of hexane to male rats. Groups of 10 male rats exposed to various large concentrations of hexane vapor for 4 hrs. Animals were then observed for clinical signs and mortality for at least the next 6 days. Several animals died during the exposure period. Surviving animals experienced severe toxicological effects during the exposure. One animal experienced convulsions during and after exposure, and died on day 6 post-exposure. The LC50 was determined to be 73,680 ppm (259354 mg/m3). Due to the high concentration of the LC50, the test substance would not be classified as toxic by inhalation according to OECD GHS guidelines.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

> 259 354 mg/m³ air

Physical form:

inhalation: vapour

Quality of whole database:

One key read across study from a structural analogue 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

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable, well-documented publication that closely follows OECD Guideline 402.

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2-3 kg

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Type of wrap if used: saran wrap sleeve


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was wiped with damp towels
- Time after start of exposure: 4 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg

Duration of exposure:

4 hrs

Doses:

up to 5.0 ml/kg

No. of animals per sex per dose:

3 males

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Statistics:

method of Litchfield and Wilcoxen

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Remarks on result:

other: 3.35 g/kg

Mortality:

No mortality was observed.

Clinical signs:

other: Animals showed signs of discomfort and were uncoordinated at the end of the exposure period.

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The 4-hr LD50 for dermal exposure in rabbits is > 5.0 ml/kg bw (3.35 g/kg).

Executive summary:

This study examined the dermal toxicity of the hexane. Doses of up to 5.0 ml/kg of test substance was placed on the shaved skin of 3 male rabbits. The test area was then covered with a saran wrap sleeve for 4 hrs. After the exposure period, the test substance washed off, and the animals observed for toxicity and mortality over the next 14 days. No animals died, however, they did show signs of discomfort and uncoordination after the exposure. The LD50 for dermal exposure is > 5.0 ml/kg (3.35 g/kg). The test substance is not classified as toxic under EU GHS guidelines.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 3 350 mg/kg bw

Quality of whole database:

One key read across study from a structural analogue available for assessment.

Additional information

There is no acute oral, inhalation, and dermal toxicity data available for Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich. However, data is available for structural analogue 5 -80% n-hexane and presented in the dossier. This data is read across to Hydrocarbons, C5 -C7, n-alkanes, isoalkanes, n-hexane rich based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Oral

  

5 -80% n-hexane

In a key study (Hine, 1970) the oral toxicity of commercial hexane was examined. 6 male rats were given doses of up to 25 ml/kg of test substance by oral gavage. The animals were then observed for 14 days for mortality. No mortality was observed at any of the doses. The oral LD50 is therefore > 25 ml/kg (16.75 g/kg; density of 0.67) which makes this substance not classified under EU GHS guidelines.

Inhalation

 

5 -80% n-hexane

In a key study (Hine, 1970) the acute inhalation toxicity of hexane to male rats was examined. Groups of 10 male rats exposed to various large concentrations of hexane vapor for 4 hrs. Animals were then observed for clinical signs and mortality for at least the next 6 days. Several animals died during the exposure period. Surviving animals experienced severe toxicological effects during the exposure. One animal experienced convulsions during and after exposure, and died on day 6 post-exposure. The LC50 was determined to be 73,680 ppm (259354 mg/m3). Due to the high concentration of the LC50, the test substance would not be classified as toxic by inhalation according to OECD GHS guidelines

Dermal

 

5 -80% n-hexane

In a key study (Hine, 1970) the dermal toxicity of the hexane was examined. Doses of up to 5.0 ml/kg of test substance was placed on the shaved skin of 3 male rabbits. The test area was then covered with a saran wrap sleeve for 4 hrs. After the exposure period, the test substance washed off, and the animals observed for toxicity and mortality over the next 14 days. No animals died, however, they did show signs of discomfort and uncoordination after the exposure. The LD50 for dermal exposure is > 5.0 ml/kg (3.35 g/kg). The test substance is not classified as toxic under EU GHS guidelines.

Justification for classification or non-classification

Based on available read across data, Hydrocarbons, C5-C7, n-alkanes, isoalkanes, n-hexane rich is minimally toxic via ingestion where the LD₅₀ >16750 mg/kg, via dermal exposure where the LD₅₀ >3500 mg/kg, and by inhalation where the LC₅₀ > 259354 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, C5-C7, n-alkanes, isoalkanes, n-hexane rich 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).