Diisotridecyl phthalate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is rated a "2" because appropriate testing methods were used; however, the study predates GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich

EC Number:

271-091-4

EC Name:

1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich

Cas Number:

68515-49-1

IUPAC Name:

bis(8-methylnonyl) phthalate

Test animals

Species:

other: albino rats, mice and guinea pigs

Strain:

other: other

Sex:

male/female

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

A stream of clean, dry air (-40 deg dewpoint) was passed through the undiluted test material and into the exposure chamber.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

6 h

Concentrations:

0.13 mg/l air

No. of animals per sex per dose:

Test groups:
5 animals/species/sex/dose. A total of 30 animals were used, 10 rats, 10 mice, 10 guinea pigs, 5 of each sex.

Control Groups:
A total of 15 animals were used, 5 rats, 5 mice, 5 guinea pigs. For each species, 3 were males and 2 were females.

Control animals:

yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.13 mg/L air

Exp. duration:

6 h

Mortality:

No animals died during the study.

Body weight:

The average 2 week body weight gains were within the normal limits except for 1 male guinea pig that lost 175 g. The remaining 4 guinea pigs weights were averaged.

Gross pathology:

Necropsy, performed on all animals at the end of the observation period, revealed no gross pathologic alterations.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The test substance is expected to have a low order of acute toxicity by the inhalation route, due to its very low vapor pressure and the results obtained.

Executive summary:

A 6-hour exposure inhalation study was conducted in rats, mice and Guinea pigs (5 males and 5 females) at 0.13 mg/l (nominal concentration). DIDP is indicated to be administered as a vapour, but regarding the test conditions the substance was probably administered as an aerosol. No death occurred, no adverse reactions were noticed following the 14-day observation period, no gross tissue changes attributable to effects of the test material were observed in any of the animals examined.