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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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other: Non-guideline study, GLP status uncertain, available as unpublished report, adequate for assessment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