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Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only a summary report was available for review.
Remarks:
There were extremely limited details on the methodology, and the report was just on the histopathology findings.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
other: no data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2, 4, 6 or 8 weeks
Frequency of treatment:
six hours per day
Doses / concentrations
Dose / conc.:
1 mg/m³ air
No. of animals per sex per dose:
No data
Control animals:
not specified

Results and discussion

Effect levels

Dose descriptor:
LOAEC
Effect level:
1 mg/m³ air
Sex:
male

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

All dosed animals showed inflammation alterations in larynx. Due to test article deposits there was evidence of mucosa erosions, retention of the test compound in subepithelial connective tissue, chronic foreign body reaction, reactive hyperplasia of epithelium, and eosinophils in ulceration area as well as in hyperplastic epithelium.

Applicant's summary and conclusion

Conclusions:
In a subacute inhalation study, Wistar rats were exposed, nose-only, to a sodium salt of DEHP (actual salt tested
not clear) at a concentration of 1.0 mg/m3, six hours per day for 21 days. All dosed animals showed inflammatory alterations in the larynx. Due to test article deposits there was evidence of mucosa erosions, retention of the test compound in subepithelial connective tissue, chronic foreign body reaction, reactive hyperplasia of epithelium, and eosinophils in ulceration area as well as in hyperplastic epithelium.
Executive summary:

In a subacute inhalation study, Wistar rats were exposed, nose-only, to a sodium salt of DEHP (actual salt tested

not clear) at a concentration of 1.0 mg/m3, six hours per day for 21 days. All dosed animals showed inflammatory alterations in the larynx. Due to test article deposits there was evidence of mucosa erosions, retention of the test compound in subepithelial connective tissue, chronic foreign body reaction, reactive hyperplasia of epithelium, and eosinophils in ulceration area as well as in hyperplastic epithelium.