Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

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

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given:comparable to guidelines/standards.

Justification for type of information:

Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

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

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given:comparable to guidelines/standards.

Justification for type of information:

Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

reference to same study

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 13.1 mg/L air

Exp. duration:

4 h

Remarks on result:

other: near saturation level

Mortality:

None

Interpretation of results:

study cannot be used for classification

Conclusions:

The LC50 for inhalation toxicity in rats is > 13.1 mg/l, which is near the maximum attainable vapor concentration. The LC50 for the test substance is greater than the saturation concentration.

Executive summary:

This data is being read across from the source study that tested Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) based on analogue read across.

This study examined the inhalation toxicity of Dilutine M5 to rats. Two male and two female rats were exposed to test atmosphere containing near saturation concentration of the test substance vapors (13.1 mg/l air) for 4 hrs. After exposure, the rats were observed for the next 14 days for mortality. No rats died during the course of the study. Therefore, the LC50 for the test substance is > 13.1 mg/l air. Since this concentration is near the saturation concentration, the LC50 is greater than the saturation concentration. The test substance is not toxic via inhalation, and is not classified an inhalation toxin under OECD GHS or EU CLP guidelines.

Cross-reference 2

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

EC Number:

919-446-0

Molecular formula:

None available. Not a single isomer, see remarks.

IUPAC Name:

Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd., Manston, Kent, UK
- Age at study initiation: 7-8 weeks
- Housing: tubular glass chamber, 2 of each sex
- Diet (e.g. ad libitum): ad libitum, except during 4 hr exposure period
- Water (e.g. ad libitum): ad libitum, except during 4 hr exposure period

Administration / exposure

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: tubular glass chamber
- System of generating particulates/aerosols: dynamically

TEST ATMOSPHERE
- Brief description of analytical method used: continuously by a high temperature total hydrocarbon analyser

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

13.1 mg/l (near saturation)

No. of animals per sex per dose:

2

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 13.1 mg/L air

Exp. duration:

4 h

Remarks on result:

other: near saturation level

Mortality:

None

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The LC50 for inhalation toxicity in rats is > 13.1 mg/l, which is near the maximum attainable vapor concentration. The LC50 for the test substance is greater than the saturation concentration.

Executive summary:

This study examined the inhalation toxicity of Dilutine M5 to rats. Two male and two female rats were exposed to test atmosphere containing near saturation concentration of the test substance vapors (13.1 mg/l air) for 4 hrs. After exposure, the rats were observed for the next 14 days for mortality. No rats died during the course of the study. Therefore, the LC50 for the test substance is > 13.1 mg/l air. Since this concentration is near the saturation concentration, the LC50 is greater than the saturation concentration. The test substance is not toxic via inhalation, and is not classified an inhalation toxin under OECD GHS or EU CLP guidelines.