N-[[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]carbamoyl]-2,6-difluorobenzamide

Stability: thermal, sunlight, metals

Link to relevant study record(s)

Reference

Endpoint:

stability: thermal, sunlight, metals, other

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 March 2001 - 06 April 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from the standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines and conducted under GLP conditions.

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.6313 (Stability to Sunlight, Normal and Elevated Temperature, Metals and Metal Ions)

Deviations:

no

GLP compliance:

yes

Test substance thermally stable:

yes

Key result

Operating temp.:

20 °C

Key result

Operating temp.:

50 °C

Sublimation:

no

Transformation products:

no

Test substance stable to metals / metal ions:

yes

Table 2: Results

Sample - Metal/Metal Ions	Temperature (°C)	Percent Recovered on Day:
		1	2	7	16
Test material - Brass	20	99.2	97.9	100.0	98.1
	50	98.7	98.4	96.7	97.6
Test material - Iron	20	98.7	98.0	91.7	98.6
	50	98.4	97.7	100.7	97.7
Test material - 316 Stainless Steel	20	98.4	97.4	96.8	97.7
	50	97.6	96.3	96.6	97.0
Test material - Aluminium	20	98.2	98.1	97.6	97.9
	50	98.6	98.6	91.6	97.7
Test material - Iron (III) chloride	20	100.1	98.3	98.0	98.6
	50	99.8	98.9	100.7	99.3
Test material - Nickel (II) chloride	20	99.6	98.8	99.5	98.4
	50	97.7	98.4	92.3	97.4
Test material - None	20	98.4	97.5	97.2	97.6
	50	98.6	97.6	94.4	97.0

Minimal change in concentration of the test material was noted when stored at elevated temperatures for 16 days and in the presence of metals or metal ions. The data from the day 7 samples showed a large variation when compared to previous and subsequent time points. The range of recovery for this day was from 91.6 to 100.7 %, whereas the recovery at all other time points (at both temperatures) was within 2.3 %.

Conclusions:

Under the conditions of the test, minimal change in concentration of the test material was observed after 16 days of exposure to elevated temperature and in the presence of metals and metal ions. At least 97.0 % of the initial concentration was recovered.

Executive summary:

The stability of the test material to metal and metal ions at elevated temperature was determined in a study performed under GLP conditions according to the standardised guideline EPA OPPTS 830.6313.

The stability of the test material was determined at 20 and 50 °C in the presence of metals or metal ions for 16 days (brass, iron, 316 stainless steel, aluminium, iron (III) chloride and nickel (II) chloride). The concentration of the test material was determined using HPLC analysis.

Under the conditions of the test, minimal change in concentration of the test material was observed after 16 days of exposure to elevated temperature and in the presence of metals and metal ions. At least 97.0 % of the initial concentration was recovered.

Description of key information

The test material was found to be stable at elevated temperature and in the presence of metals or metal ions under the conditions of the test; EPA OPPTS 830.6313, Russell 2001

Additional information

The stability of the test material to metal and metal ions at elevated temperature was determined in a study performed under GLP conditions according to the standardised guideline EPA OPPTS 830.6313. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). 

The stability of the test material was determined at 20 and 50 °C in the presence of metals or metal ions for 16 days (brass, iron, 316 stainless steel, aluminium, iron (III) chloride and nickel (II) chloride). The concentration of the test material was determined using HPLC analysis.

Under the conditions of the test, minimal change in concentration of the test material was observed after 16 days of exposure to elevated temperature and in the presence of metals and metal ions. At least 97.0 % of the initial concentration was recovered.

Justification for classification or non-classification

A guideline study shows the stability of the substance. Criteria of GHS for classification not met.