Benzyl butyl phthalate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

other company data

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In an acute dermal toxicity study, the test material was applied to the skin of rabbits at one of three doses, and animals assessed for toxic symptoms.

GLP compliance:

no

Test type:

other:

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
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: QE-29401

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0-2.2 kg

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

No data

Duration of exposure:

24 hours

Doses:

3.98, 6.31 and 10.0 g/kg bw

No. of animals per sex per dose:

One male was tested at 3.98 g/kg bw, one female at 6.31 g/kg bw, and one male and one female at 10.0 g/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, macroscopic evaluation

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

All four animals survived the 14-day observation period

Clinical signs:

other: Reduced appetite and activity seen for two to four days (number of animals and doses not given)

Gross pathology:

The viscera of the survivors appeared normal following macroscopic examination

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There were no deaths when four rabbits (2/sex) were given a 24-hour skin application of undiluted Santicizer 160 at up to 10.0 g/kg bw and then observed for 2 weeks. Although details of the study are only available in a brief summary report (hence it has been assigned reliability code 4), the data are considered adequate for assessment.

Executive summary:

Undiluted Santicizer 160 was applied to the skin of four New Zealand white rabbits. One male was dosed at each of 3.98 and 10.0 g/kg bw, and one female dosed at each of 6.31 and 10.0 g/kg bw, for an exposure period of 24 hours (no further details given on exposure conditions). The animals were assessed for toxic symptoms during the observation period, and the animals were sacrificed 14 days after dosing and examined macroscopically.

 

All four animals survived the 14-day observation period. Reductions in appetite and activity were seen for 2 -4 days (no details provided on the doses at which these effects were seen). At necropsy, the viscera appeared normal. The investigators concluded that the LD50 was greater than 10.0 g/kg bw. Under the EU CLP regulations, this study would indicate that Santicizer 160 should not be classified for acute dermal toxicity.