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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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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

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.