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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: EU RAR, secondary literature, however, the rapporteur member state (France) has evaluated the study report for the EU RAR

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 43CFR163 (EPA proposed test guideline, 1978)
GLP compliance:
not specified
Test type:
standard acute method

Test material

Constituent 1
Reference substance name:
DINP
IUPAC Name:
DINP
Details on test material:
Diisononylphthalate, no information on CAS No available. Note that the different DINP's in the market are regarded as technically exchangable and have been evaluated together for different reasons as outlined in the EU RAR rationale

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
5 animals per sex

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
4.40 mg/l (nominal)
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.4 mg/L air (nominal)
Exp. duration:
4 h
Remarks on result:
other: aerosol

Any other information on results incl. tables

LC50 > 4.4 mg/l (nominal concentration) (Hazleton, 1980) DINP (no information on the CAS number) was administered as an aerosol to ten Sprague- Dawley rats (5 males and 5 females) at a nominal concentration of 4.40 mg/l which was according to the testing facility the highest attainable concentration in air during 4 hours (The report has conflicting information as once in the report a nominal concentration of 5.0 -5.5 mg/l is listed, however on two other pages the nominal concentration is indicated to be 4.40 mg/l). Gravimetric evaluation of the aerosol resulted in concentrations of approx. 1.7 mg/l. Particle sizing was also undertaken showing that majority of teh non-volatile mass collected by the mini-impactor was in the respirable range (i.e. less than 5 micron). A control group of ten Sprague-Dawley rats (5 males and 5 females) received air. The observation period was 14 days. All treated animals were observed to have slight tearing of the eyes and slight clear nasal discharge starting 40 minutes after exposure was initiated. One male was observed to have blood around both eyes on day 4 and a slight brownish discharge around both eyes on days 5 to 10; from day 8 to 10, this animal had developed an opaque spot on one eye. All other animals exhibited normal behaviour and appearance throughout the exposure period. No animal died during this study, no definite compound-related changes of body weight, no consistent compound-related gross lesions, no compound-related microscopic alterations of lungs, liver and kidneys in the treated animals were observed.

Applicant's summary and conclusion