Manganese Violet

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

other: extrapolation from results obtained by the oral route

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.

Data source

Reference

Reference Type:

other: extrapolation

Title:

Unnamed

Year:

2012

Materials and methods

Principles of method if other than guideline:

Extrapolation based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals.

GLP compliance:

no

Test type:

other: extrapolation

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium manganese diphosphate, monoclinic and triclinic

Molecular formula:

MnKx (NH4)1-x P2O7 (0 =< x =< 0.5)

IUPAC Name:

Ammonium manganese diphosphate, monoclinic and triclinic

Results and discussion

Effect levels

Key result

Dose descriptor:

LC50

Effect level:

50 mg/L air (nominal)

Clinical signs:

other:

Any other information on results incl. tables

Based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, an extrapolation based on the acute oral toxicity data is calculated for the inhalation route.

From the available data on an acute oral toxicity study, it is concluded that the oral LD50 for the substance is 12900 mg/kg bw and the LD0 is 10000 mg/kg bw. As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 100% of an orally administered dose is systemically available. Since no data is available on inhalation absorption, the most precautionary default would be to assume 100% absorption by this route.

Based on this acute oral toxicity data, an oral NOAEL may be identified as 10000 mg/kg bw. This NOAEL can be modified into an inhalation NOAEL using a route-to-route extrapolation based on the assumptions stated above. Taking into account an exposure of 4 hours for the acute inhalation toxicity study, the value of the oral LD50 is divided by the default physiological parameter under the allometric scaling principle which is approximately 0.2 m3/kg bw for rats. This extrapolation leads to a value of 50 mg/l. Therefore, the 4 -h LC50 would be 50 mg/l.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the assumptions for the extrapolation from the acute oral toxicity data, the 4 -h LC50 would be 50 mg/l.

Executive summary:

From the available data on an acute oral toxicity study, it is concluded that the oral LD50 for the substance is 12900 mg/kg bw and the LD0 is 10000 mg/kg bw. As recommended in the corresponding guidelines, where data from the oral route is being used as the starting point, if no data are available on oral bioavailability, it is appropriate to assume that 100% of an orally administered dose is systemically available. Since no data is available on inhalation absorption, the most precautionary default would be to assume 100% absorption by this route.

Based on this acute oral toxicity data, an oral NOAEL may be identified as 10000 mg/kg bw. This NOAEL can be modified into an inhalation NOAEL using a route-to-route extrapolation based on the assumptions stated above. Taking into account an exposure of 4 hours for the acute inhalation toxicity study, the value of the oral LD50 is divided by the default physiological parameter under the allometric scaling principle which is approximately 0.2 m3/kg bw for rats. This extrapolation leads to a value of 50 mg/l. Therefore, the 4 -h LC50 would be 50 mg/l.