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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: Older study: meets scientific standards with acceptable restrictions (e.g. partly limited documentation)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: Study from 1976 (no guidelines available at the time the study was performed).
Deviations:
not applicable
Principles of method if other than guideline:
6 male SD rats were exposed (whole body) to 2100 mg TS/m3
GLP compliance:
no
Remarks:
Study from 1976 (GLP was not compulsory at the time the study was performed).
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Lot/batch No.: XF 958

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
No further data

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
other: air
Details on inhalation exposure:
Initial sample: 107.2 g
Recovered sample: 104.1 g
Condensed sample: 0.0 g
Vaporised sample: 3.1 g
Chamber temperature: 25 degrees C
Chamber humidity: 80 %
Chamber volume: 35 L
Air flow rate: 4.0 L/min
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
6 h
Concentrations:
2100 mg/m3
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
Initial sample: 107.2 g
Recovered sample: 104.1 g
Condensed sample: 0.0 g
Vaporised sample: 3.1 g
Chamber temperature: 25 degrees C
Chamber humidity: 80 %
Chamber volume: 35 L
Air flow rate: 4.0 L/min
Statistics:
No data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 2 100 mg/m³ air
Based on:
test mat.
Exp. duration:
6 h
Remarks on result:
other: LC0
Mortality:
0/6
Clinical signs:
other: None
Body weight:
No data
Gross pathology:
14 days: viscera appeared normal

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC0 value for male rats was > 2100 mg/m3 for 6h exposure, which correspond to CL50 / 4h > 3,15 mg/kg. As for cumene (isopropylbenzene) the LC0 is > 5.5 mg/L mist it is anticipated that DIPB LC50 is >5 mg/kg mist.
Executive summary:

In this older study 6 male Sprague-Dawley strain albino rats were exposed to 2100 mg TS/m3 (whole body) over 6 hrs. None of the animals died and the viscera appeared normal 14 days after dosing. This correspond to CL0 / 4h > 3,15 mg/kg and certainly to a CL50 > 5 mg/L mist with dermal exposure.

There are 2 studies with DIPB and Cumene, indicating LC0 respectively at 2100 mg/m3 (6h) and 17600 mg/m3 (1h), while they have vapour pressure of 0.34 and 4.9 hPa. We do not know really if they are based on saturating Vps, anyway needing to heat the substance which will condensate to aerosol when reaching the rat whole exposure cages. We can estimate the 4 hours value with the Haber law, either with C.t=K or C3.T=K In the first case CL0 would be 3.15 and 5.18 mg/L respectively. In the second case the CL0 will be for DIPB and Cumene of 2.41 and 11.1 mg/L. From these data it is assumed that the CL50 of DIPB is > 5 mg/L aerosol, leading to no CLP classification.