Nitrapyrin

Endpoint summary

Description of key information

Acute toxicity oral:
Several LD50 values were cited in peer reviewed and authorative secondary sources with no information on methodology as dose decriptors were provided only. Based on these results, the acute oral toxicity of test item was low to moderate with the lowest LD50 value of 713 mg/kg bw derived for the species mouse (Yano et al., 2008).
Acute toxicity inhalation: 
A LD50 value of > 0.03 mg/L air was cited in an authorative secondary source (US-EPA, 2005) with no information on methodology as dose descriptor was provided only. 
Acute toxicity dermal:
Two contradicting dose descriptors for were cited in two authorative secondary sources for the species rabbit (LD50 rabbit: > 2000 mg/kg bw  (US-EPA, 2005) and 850 mg/kg bw  (Health Council of the Netherlands, 2002).  

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:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Peer reviewed secondary source with dose decriptor provided only.

Principles of method if other than guideline:

Secondary literature source no data about the method was available.

GLP compliance:

not specified

Species:

mouse

Strain:

not specified

Sex:

female

Route of administration:

oral: unspecified

Vehicle:

not specified

Control animals:

not specified

Sex:

female

Dose descriptor:

LD50

Effect level:

713 mg/kg bw

Based on:

not specified

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

713 mg/kg bw

Quality of whole database:

Data origins from peer reviewed secondary source with dose decriptor provided only.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Authorative secondary source with dose decriptor provided only. Original study report was not available.

Principles of method if other than guideline:

Secondary literature source no data about the method was available.

GLP compliance:

not specified

Species:

rat

Strain:

Fischer 344

Sex:

not specified

Dose descriptor:

LC50

Effect level:

> 0.03 mg/L air

Remarks on result:

other: no effects (technically limited atmospheric conc.)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

0.03 mg/m³

Quality of whole database:

Data origins from peer reviewed secondary source with dose decriptor provided only.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Authorative secondary source with dose decriptor provided only. Original study report was not available.

Principles of method if other than guideline:

Secondary literature source no data about the method was available.

GLP compliance:

not specified

Species:

rabbit

Sex:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Acute toxicity oral:

Several LD50 values were cited in peer reviewed and authorative secondary sources with no information on methodology provided (dose descriptor cited only). The acute oral toxicity of test item was regarded as low to moderate based on the following oral LD50 values: LD50 mouse: 713 mg/kg bw (Yano et al., 2008); LD50 rat: 1072 mg/kg bw for males, 1231 mg/kg bw for females (Yano et al., 2008), 940 mg/kg bw (Health Council of the Netherlands, 2002); LD50 rabbit: 850 mg/kg bw (Health Council of the Netherlands, 2002).

Acute toxicity inhalation:

A LD50 value of > 0.03 mg/L air was cited in an authorative secondary source (US-EPA, 2005) with no information on methodology (dose descriptor provided only). No adverse effects were observed.

Acute toxicity dermal:

Two contradicting dose descriptors were cited in two authorative secondary sources for the species rabbit. The LD50 for rabbits was cited to be greater than 2000 mg/kg bw (US-EPA, 2005) and to be 850 mg/kg bw (Health Council of the Netherlands, 2002). For classification and labelling the LD50 of US-EPA evaluation was used.

Justification for selection of acute toxicity – oral endpoint
Lowest dose descriptor available.

Justification for selection of acute toxicity – inhalation endpoint
Sole reference available.

Justification for selection of acute toxicity – dermal endpoint
Data origins from peer reviewed secondary source with dose decriptor provided only.

Justification for classification or non-classification

Acute oral toxicity

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result and according to the harmonised Annex I classification the substance is considered to be classified for acute oral toxicity Xn R22: Harmful if swallowed under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.  

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result and according to the harmonised Annex VI classification the substance is considered to be classified for acute oral toxicity cat. 4, H302: Harmful if swallowed under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

Acute inhalation toxicity

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under Directive 67/548/EEC. As a result and according to the harmonised Annex I classification the substance is not considered to be classified for acute inhalation toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.  

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result and according to the harmonised Annex VI classification the substance is not considered to be classified for acute inhalation toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

Acute dermal toxicity

Dangerous Substance Directive (67/548/EEC)

According to the harmonised Annex I classification the substance is not considered to be classified for acute dermal toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.  

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

According to the harmonised Annex VI classification the substance is not considered to be classified for acute dermal toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.