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Administrative data

Description of key information

see endpoints

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, with certain restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only 7-day observation period
Principles of method if other than guideline:
BASF-Test
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gassner
- Age at study initiation: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
No additional data
Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%
No additional data provided
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: body weight was determined before the start of the study for determination of dose. Animals were observed approximately 1-3 hours after dosing and then daily over a period of 7 days.
- Necropsy of survivors performed: yes; at necropsy, all rats were examined for gross pathological changes. No further details available.
Statistics:
None
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 279 mg/kg bw
Based on:
test mat.
Remarks on result:
other: the LD50 was 6279.0 mg/kg bw (calculated from 6.0 ml/kg bw assuming test substance density of 1.0465 g/ml)
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 279 mg/kg bw

Acute toxicity: via inhalation route

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Reference
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
Qualifier:
no guideline available
Principles of method if other than guideline:
no data
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
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
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.

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.

Endpoint conclusion
Dose descriptor:
LC50
Value:
15 680 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Dose descriptor:
LD50
Value:
20 000 mg/kg bw

Additional information

taken from EU RAR Dibutyl phthalate (2004):

Conclusion on acute toxicity

The oral LD50 value for the rat is ≥6,300 mg/kg bw for dibutyl phthalate; the dermal LD50 is >20,000 mg/kg bw for the rabbit. With respect to inhalation the 4h LC50 for dibutyl phthalate is ≥15.68 mg/L for the rat. According to the EC criteria, dibutyl phthalate does not need to be classified on the basis of its acute toxicity.

Conclusion taken from Australian DBP Hazard Assessment (Draft, 2007) - in line with EU RAR Dibutyl phthalate (2004):

The oral LD50 value for rats is 6300 – 8000 mg/kg bw/d, the dermal LD50 for rabbits is >20000 mg/kg bw/d and the inhalational LC50 (4 h) for rats is ≥15.68 mg/L

Justification for classification or non-classification

According to the EC criteria, dibutyl phthalate does not need to be classified on the basis of its acute toxicity.

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