Benzyl butyl phthalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles (although the rats were not subject to necropsy).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Animals not subject to necropsy

GLP compliance:

not specified

Test type:

standard acute method

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): butyl benzyl phthalate
- Substance type: no data
- Physical state: no data
- Analytical purity: about 98%
- Impurities (identity and concentrations): no data
- Purity test date: February 1978
- Lot/batch No.: Lot No. M2676
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: stored in dark

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: NCI Frederick Cancer Research Center, Frederick, Maryland, USA
- Age at study initiation: 4 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: suspended polycarbonate cages on hardwood chips as bedding
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°-26°C
- Humidity (%): 10-88
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: no data

Doses:

0.08, 0.16, 0.31, 0.63, 1.25, 2.5, 5, 10 and 20 g/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 330 mg/kg bw

Mortality:

2/5 males and 2/5 females died at 2.5 g/kg bw, and all rats died at 5, 10 and 20 g/kg bw.

Clinical signs:

other: no data

Gross pathology:

not examined

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Butyl benzyl phthalate was of low acute oral toxicity to rats when tested at up to 20 g/kg bw. The LD50 was estimated to be 2.33 g/kg bw for both sexes.

Executive summary:

In a reliable study, butyl benzyl phthalate was assessed for acute oral toxicity in male and female F344/N rats. Groups of five rats of each sex were dosed with up to 20 g/kg bw by oral gavage, and surviving animals were observed for 14 days. Deaths occurred in both sexes at 2.5 g/kg bw and above, and the LD50 was estimated at 2.33 g/kg bw for both sexes. This indicates that butyl benzyl phthalate is of low acute oral toxicity to rats.