pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate

Acute Toxicity: inhalation

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

Study period:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted and reported study according to GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

6-h instead of a 4-h exposure

Principles of method if other than guideline:

Although the study was started as a 5-day inhalation study, some animals of the high concentration group died after the first day of exposure. The remainder of this group was therefore not exposed any further and kept for a 14-day observation period.

GLP compliance:

yes (incl. QA statement)

Test type:

other: see below at Principles of method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium dihydrogen ethylenediaminetetraacetate

EC Number:

205-358-3

EC Name:

Disodium dihydrogen ethylenediaminetetraacetate

Cas Number:

139-33-3

IUPAC Name:

disodium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate

Details on test material:

Purity 91.7%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

clean air

Details on inhalation exposure:

A dust aerosol was generated.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

gravimetry

Duration of exposure:

6 h

Concentrations:

0, 30, and 300 and mg/m3, 5 consecutive days
1000 mg/m3, one day

No. of animals per sex per dose:

20 per group at 0 and 1000 mg/m3 (10 for the main study and 10 recovery animals)
10 per group at 30 and 300 mg/m3

Control animals:

yes

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

other: LC30

Effect level:

1 000 mg/m³ air (nominal)

Based on:

test mat.

Exp. duration:

6 h

Mortality:

6 out of 20 animals of the high concentration group died after the first exposure or the day after. The others of this group were kept for 14 days (as if it were an acute inhalation study).

Clinical signs:

other: Several respiratory tract changes

Body weight:

Decreased

Gross pathology:

Congestion, oedema and multifocal haemorrhages in animals of the high concentration group

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

Based on a 6-h LC30 value (30% mortality following a 6-h exposure), it can be assumed that the 4-h LC50 value will be between 1000 and 5000 mg/m3.