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Administrative data

Description of key information

In an OECD guideline study, the acute oral LD50 value for diammonium sodium hexakis(nitrito-N)rhodate was determined to exceed 2000 mg/kg bw following gavage administration in female rats.

 

No relevant acute dermal or inhalation toxicity data were identified.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 April - 12 May 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Conducted according to GLP
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
up-and-down procedure
Limit test:
yes
Species:
rat
Strain:
other: CRL:(WI) rats
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation:8-11 weeks
- Weight at study initiation: 202-231 g
- Fasting period before study: overnight prior to treatment
- Housing: Individual caging in Type II polypropylene/polycarbonate cages with Lignocel Bedding for Laboratory Animals and deep wood sawdust bedding to allow digging and other normal rodent activities.
- Diet (e.g. ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum
- Water (e.g. ad libitum): tap water from the municipal supply, from 500 ml bottles, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 – 23.3
- Humidity (%): 37-60
- Air changes (per hr): 15 – 20
- Photoperiod (hrs dark / hrs light): 12/12
Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
1%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: various
- Amount of vehicle (if gavage): 1.0-1.2 ml/animal
- Justification for choice of vehicle: based on trial formulations with the test item
- Lot/batch no. (if required): 1D30012N13
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 1.2 ml/animal

- Rationale for the selection of the starting dose: The doses were selected from the sequence 1.75, 5.5, 17.5, 55, 175, 550, 2000 mg/kg bw. A starting dose of 175 mg/kg bw was selected after discussions between the Study Director and the Sponsor.
Doses:
175, 550, 2000 mg/kg bw
No. of animals per sex per dose:
1 (in lower two dose groups); 3 (in highest dose group)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observation after dosing at 30 minutes, then at 1, 2, 3, 4, and 6 hours, then once each day for 14 days thereafter. Weighing one day before and on the day of treatment (day 0), and on days 7 and 14 after treatment.
- Necropsy of survivors performed: yes
- Observations: these included the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsies: macroscopic examination of the external appearance and of the tissues and organs of the cranial, thoracic and abdominal cavities.
Statistics:
The Acute Oral Toxicity (OECD Test Guidelines 425) Statistical Programme (AOT 425 Stat Pgm) was used to evaluate data.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: CL not applicable
Mortality:
None
Clinical signs:
None
Body weight:
No indication of a treatment-related effect for body weight or body weight gain
Gross pathology:
No macroscopic observations
Other findings:
None
Interpretation of results:
GHS criteria not met
Conclusions:
In an OECD guideline study, the acute oral LD50 value for diammonium sodium hexakis(nitrito-N)rhodate was determined to exceed 2000 mg/kg bw following gavage administration in female rats.
Executive summary:

The acute oral toxicity of diammonium sodium hexakis(nitrito-N)rhodate was assessed in female rats, in a study carried out in accordance with OECD guideline 425 and to GLP. Animals were treated by gavage with the test material (in 1% methyl cellulose) at doses of 175 (1 animal), 550 (1 animal) or 2000 (3 animals) mg/kg body weight. Macroscopic examination was conducted on surviving animals.

 

No mortality, clinical signs or effects on body weight/growth were apparent during the 14-day post-dose observation period, and there were no notable external or internal macroscopic findings upon necropsy. The study investigators concluded that the acute oral median lethal dose (LD50) of diammonium sodium hexakis(nitrito-N)rhodate was greater than 2000 mg/kg bw in female rats.

 

Based on the results of this study, diammonium sodium hexakis(nitrito-N)rhodate does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Overall, good-quality database which meets REACH Standard Information Requirements

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No relevant acute toxicity human data were identified.

 

The acute oral toxicity of diammonium sodium hexakis(nitrito-N)rhodate was assessed in female rats, in a study carried out in accordance with OECD Test Guideline 425 and to GLP. Animals were treated by gavage with the test material (in 1% methyl cellulose) at doses of 175 (1 animal), 550 (1 animal) or 2000 (3 animals) mg/kg body weight. Macroscopic examination was conducted on surviving animals. No mortality, clinical signs or effects on body weight/growth were apparent during the 14-day post-dose observation period, and there were no notable external or internal macroscopic findings upon necropsy. The study investigators concluded that the acute oral median lethal dose (LD50) of diammonium sodium hexakis(nitrito-N)rhodate was greater than 2000 mg/kg bw in female rats (Matting, 2014).

 

No acute inhalation toxicity data were identified. However, the compound is not expected to reach the lungs in appreciable quantities (based on respiratory tract deposition modelling data). Thus, inhalation will not be a significant route of exposure. Similarly, no acute dermal toxicity data were identified. However, this study does not need to be conducted as the substance does not meet the criteria for classification for acute toxicity by the oral route.

Justification for classification or non-classification

Based on the results of the available and reliable acute oral rat study, diammonium sodium hexakis(nitrito-N)rhodate does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).

 

No evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.