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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: taken from EU RAR

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
no data
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyl phthalate
EC Number:
201-557-4
EC Name:
Dibutyl phthalate
Cas Number:
84-74-2
Molecular formula:
C16H22O4
IUPAC Name:
dibutyl phthalate
Details on test material:
A group of 5 m and 5 f Sprague-Dawley rats

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
not specified
Vehicle:
not specified
Details on inhalation exposure:
for 4 hours to an aerosol of 15.68 mg DBP/L of air. Air exposed animals served as controls. Observation period was 14 days. A second delivery of DBP was tested at 12.45 and 16.27 mg/L one month later. Respirable fraction (i.e. diameter <4.7 μm) was 56.9, 64.4 and 59.9% at 15.68, 12.45 and 16.27 mg/L. In the 15.68 mg/L group 2/5 male and 3/5 female animals died, whereas no mortalities were observed in the 12.45 and 16.27 mg/L groups.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
ca. 4 h
Concentrations:
15.68 mg DBP/L of air
12.45 and 16.27 mg/L
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
>= 15.68 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Body weight:
ung/body weight ratios in premature decedents at 15.68 mg/L were elevated, while these ratios were lower than those of controls in males at 12.45 and 16.27 mg/L.

Any other information on results incl. tables

Due to the unusual death pattern, no LC50 value could be determined, but the LC50 value was estimated to be ≥15.68 mg/L in this study which was performed under GLP conditions. At 15.68 mg/L apart from a reduction in respiratory rate, behaviour of the rats showed no differences with control animals. Poor coat condition was seen in all surviving animals during the observation period due to excessive grooming behaviour. Lung/body weight ratios in premature decedents at 15.68 mg/L were elevated, while these ratios were lower than those of controls in males at 12.45 and 16.27 mg/L. Macroscopy of the lungs revealed red/dark foci in several animals scattered among the treatment groups. One m and one f rat exposed to 15.68 mg/L had white foci in all lung lobes. Dark red areas were seen in the lungs of 2 females at 12.45 mg/L and in 1 male and 1 female rat at 16. 27 mg/L.

Applicant's summary and conclusion

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