Hydrocarbons, C4, steam-cracker distillate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-guideline study, GLP status uncertain, available as unpublished report, adequate for assessment

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

none

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

C4-mixture

IUPAC Name:

C4-mixture

Constituent 2

Reference substance name:

substance number

IUPAC Name:

substance number

Constituent 3

Reference substance name:

68467-52-8

IUPAC Name:

68467-52-8

Details on test material:

- Name of test material (as cited in study report): C4-Gemisch
- Physical state: gas
- Analytical purity: Technical grade
- Lot/batch No.: 79/530
- no further details

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 185±15 g
- Housing: 5 per cage (individually during exposure)
- Diet: Herilan MRH diet ad libitum except during exposure
- Water: ad libitum except during exposure
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C in animal room
- Humidity: 55±5%
- Air changes (per hr): not reported
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: no data

Administration / exposure

Route of administration:

inhalation: gas

Type of inhalation exposure:

whole body

Vehicle:

other: air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole-body inhalation system: stainless steel construction
- Exposure chamber volume: 200 L
- Method of holding animals in test chamber: The animals were kept singly in cages

TEST ATMOSPHERE
- Brief description of analytical method used: The nominal concentration was calculated from the amount of substance consumed and the air flow
- Quantitative determination of the vapour concentration: by gas chromatography
- From the analytically determined mass values and the sample volumes of the inhalation atmosphere the concentrations were calculated in mg/L

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Nominal concentration 5.8 mg/L, analytical concentration 5.57 mg/L.

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

no further information

Statistics:

The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test in accordance with tables of the BASF Computer Centre.

Results and discussion

Preliminary study:

none

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

5 800 other: mg/m3, (5.8 mg/L air)

Exp. duration:

4 h

Remarks on result:

other: There were no effects at the highest concentration

Mortality:

no mortalities

Clinical signs:

other: none recorded

Body weight:

no changes in body weight of treated males or females compared with control animals 7 or 14 days after treatment

Gross pathology:

none reported

Other findings:

none reported

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LC50 of the C4-mixture was > 5.8 mg/L (5800 mg/m3) in male and female rats.

Executive summary:

Male and female rats were exposed to a mixture of C4 gases for 4h at 5.8 mg/L (5800 mg/m3). There were no effects and no mortalities at the highest concentration and therefore the LD50 was greater than 5800 mg/m3 (5.8 mg/L).