Registration Dossier
Registration Dossier
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EC number: 220-552-8 | CAS number: 2809-21-4
Repeated dose toxicity: inhalation
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:
- 1 985
- Report date:
- 1985
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- (1-hydroxyethylidene)bisphosphonic acid, sodium salt
- EC Number:
- 249-559-4
- EC Name:
- (1-hydroxyethylidene)bisphosphonic acid, sodium salt
- Cas Number:
- 29329-71-3
- Molecular formula:
- C2H8O7P2.xNa
- IUPAC Name:
- (1-hydroxyethylidene)bisphosphonic acid, sodium salt
Constituent 1
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.
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