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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
no data
Body weight:
not examined
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.