Benzyl butyl phthalate

Acute Toxicity: inhalation

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: Only brief summary data and results table available.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1955

Report date:

1955

Materials and methods

Principles of method if other than guideline:

Male rats were exposed to a saturated atmosphere containing Santicizer 160 for six hours

GLP compliance:

no

Test type:

other: Acute vapour inhalation study

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl butyl phthalate

EC Number:

201-622-7

EC Name:

Benzyl butyl phthalate

Cas Number:

85-68-7

Molecular formula:

C19H20O4

IUPAC Name:

1-benzyl 2-butyl benzene-1,2-dicarboxylate

Details on test material:

- Name of test material (as cited in study report): Santicizer 160 (benzyl butyl phthalate)
- Physical state: vapour
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: CP 731-(2)

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: "mature"
- Housing: "a small metal chamber"


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24
- Humidity (%): 62

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: no data

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: no data
- Exposure chamber volume: 50 L
- Method of holding animals in test chamber: no data
- Source and rate of air: no data
- Method of conditioning air: no data
- System of generating particulates/aerosols: the compound was atomised by passing a stream of compressed air at a pressure of 22 pounds per square inch through a container of fluid located inside the chamber.
- Method of particle size determination: no data
- Treatment of exhaust air: no data
- Temperature, humidity, pressure in air chamber: Av. temperature in chamber was 75.5oF and av. relative humidity 62%.


TEST ATMOSPHERE
- Brief description of analytical method used: no data


VEHICLE
no data


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: no data
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): no data

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

ca. 6 h

Concentrations:

"Saturated atmosphere"

No. of animals per sex per dose:

4 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 3 days
- Frequency of observations and weighing: "Frequent" observations; no data on weighing.
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs

Statistics:

No data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

other: No significant adverse effects reported

Exp. duration:

6 h

Remarks on result:

other: Male rats were exposed to a saturated atmosphere containing Santicizer 160 for six hours

Remarks:

Male rats were exposed to a saturated atmosphere containing Santicizer 160 for six hours

Mortality:

No deaths seen

Clinical signs:

other: Breathing was slightly irregular and moderate lethargy developed after 30 minutes (number of animals involved not indicated in report). There was mild nasal irritation, but no observable ocular irritation. The animals maintained their sense of balance whe

Body weight:

No data

Gross pathology:

no data

Other findings:

no data

Any other information on results incl. tables

No information was provided on the actual test concentration, other than it being a saturated atmosphere.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No deaths and only mild transient effects were seen when four male rats were exposed for 6 hours to a saturated atmosphere containing Santicizer 160 (benzyl butyl phthalate), and observed for 3 days.

Executive summary:

Four mature male rats were placed in a small metal chamber (50 L) and exposed (whole-body) for 6 hours to a saturated atmosphere of Santicizer 160 vapours (created by passing a stream of compressed air through a container of fluid inside the chamber), and observed "frequently" for toxic symptoms for a further 3 days.

No deaths were seen during the 3-day observation period. Breathing was slightly irregular and moderate lethargy developed after 30 minutes (number of animals involved not indicated in report). There was mild nasal irritation, but no observable ocular irritation. The animals maintained their sense of balance when moving around ("further indication that the fumes were not particularly harmful to the rat from an acute standpoint"). The animals ate and acted normally during the 3-day observation period.

As no deaths and only mild transient effects were seen in rats exposed to a saturated atmosphere containing Santicizer 160 vapours, the test material would not be classified as acutely toxic by the inhalation route according to EU CLP regulations.