Tetrasodium (1-hydroxyethylidene)bisphosphonate

Repeated dose toxicity: inhalation

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

Test material information

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.