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Toxicological information

Acute Toxicity: inhalation

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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other: Non-guideline study, GLP status uncertain, available as unpublished report, adequate for assessment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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

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).