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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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
No data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only pathological-anatomical and histopathological findings

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified
Remarks:
pre GLP
Limit test:
no

Test material

Constituent 1
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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: no data
Remarks on MMAD:
MMAD / GSD: No data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 days (plus 14 day recovery period)
Frequency of treatment:
Daily, but period not stated.
Doses / concentrations
Dose / conc.:
0.5 mg/m³ air
Control animals:
yes
Details on study design:
Post-exposure period: 14 days

Results and discussion

Effect levels

Dose descriptor:
NOAEC
Effect level:
>= 0.5 mg/m³ air
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

After 14 day nose exposure inhalation to 0.5 mg/m3 and after 14 day recovery period there were no detectable histological alterations in the nose, larynx and trachea.

Applicant's summary and conclusion

Conclusions:
In a subacute repeated dose toxicity study a salt of HEDP was administered to Wistar rats, nose-only, for 14 days, a NOAEC of 0.5 mg/m3 was established.
Executive summary:

In a subacute repeated dose inhalation toxicity study, a salt of HEDP (actual salt tested not clear) was administered to Wistar rats, nose-only, for 14 days (length of exposure period per day not stated) at a concentration of 0.5 mg/m3. There was also a 14 day recovery period. There were no detectable histological alterations in the nose, larynx and trachea. Therefore the NOAEL was at least 0.5 mg/m3.