1,2-Benzenedicarboxylic acid, benzyl isononyl alkyl esters

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only available as a brief summary report

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 two doses, and animals assessed for toxic symptoms.

GLP compliance:

not specified

Test type:

other:

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, benzyl isononyl alkyl esters

EC Number:

701-339-3

Cas Number:

68515-40-2

Molecular formula:

C24H30O4

IUPAC Name:

1,2-Benzenedicarboxylic acid, benzyl isononyl alkyl esters

Details on test material:

Name of test material (as cited in study report): Santicizer 261
- Lot/batch No.: DE 114
no further data

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: 2.2-2.5 kg
no further data

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

5.01 and 7.94 g/kg bw

No. of animals per sex per dose:

One male was tested at 5.01 g/kg bw, and one male and one female at 7.94 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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 940 mg/kg bw

Remarks on result:

other: No deaths at 7.94 g/kg bw

Mortality:

All three animals survived the 14-day observation period

Clinical signs:

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

Gross pathology:

The viscera appeared normal following macroscopic examination

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

There were no deaths when three rabbits (mixed sex) were given a 24-hour skin application of undiluted Santicizer 261 at up to 7.94 g/kg bw and then observed for two weeks.

Executive summary:

Undiluted Santicizer 261 was applied to the skin of a total of three New Zealand white rabbits. One male was dosed at each of 5.01 and 7.94 g/kg bw, and one female dosed at 7.94 g/kg bw, for an exposure period of 24 hours. The animals were assessed for toxic symptoms during the observation period, and the surviving animals sacrificed 14 days after dosing and examined macroscopically.

 

All three animals survived the 14-day observation period. Reduced appetite and activity was seen for one to three days (no details on number of animals or doses given). At necropsy, the viscera appeared normal. The investigators concluded that the LD50 was greater than 7.94 g/kg bw. Under the EU CLP regulations, this study would indicate that Santicizer 261 is not classified for acute dermal toxicity.