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Physical & Chemical properties

Stability in organic solvents and identity of relevant degradation products

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Administrative data

Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Between 18 April 2002 and 31 May 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The analytical study that was part of the 28-day repeat dose study was conducted in accordance with GLPs and included a quality assurance statement and was conducted in accordance with standard SOPs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: The 28-day study was conducted in accordance with OECD 407, but no analytical guideline was available. However, method validation was conducted.
Deviations:
no
Principles of method if other than guideline:
Stability analyses of the test material was conducted in corn oil from all dose concentrations (1, 30, 100, and 200 mg/ml). Three 5 ml samples from each concentration were obtained and stored at ambient temperature. Two of the samples from each concentration (one each for the day 4 and day 11 stability analyses) were shipped, in appropriately labeled glass vials with Teflon-lined lids, via overnight courier at ambient temperature to one of the sponsoring company's testing lab. The remaining samplesfrom each level weremaintained at SLI under ambient condition until the conclusion of the study. Test article stability was confirmed by analysing these samples for test material concentration on days 4 and 11 post-preparation after storage at ambient temperature. The average results of the day 0 homogeneity analyses were used as the baseline (day 0) value for the stability analyses. All samples were analyzed fro calcium, an element present at known concentrations in the test material.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Test Material: TSD101B
Description: Dark brown liquid
Substance is the sulphonate salt in mineral oil and provides information on the product but not the instrinsic properties of the sulphonate

Results and discussion

Test substance stable:
yes
Transformation products:
not measured

Any other information on results incl. tables

Table 1. 4-Day and 11-Day Stability Study

Day

Dose Concentration mg/ml

Measured Concentration wt% Calcium

Baseline Valueawt% Calcium

Precent Difference (%)

4

10

0.030

0.031

3.2

11

10

0.029

0.031

6.5

4

30

0.087

0.089

2.2

11

30

0.088

0.089

1.1

4

100

0.288

0.292

1.4

11

100

0.290

0.292

0.7

4

200

0.570

0.582

2.1

11

200

0.591

0.582

1.5

aAverage result of three homogeneity samples analyzed

Applicant's summary and conclusion

Conclusions:
The test material is stable in corn oil.

Substance is the sulphonate salt in mineral oil and provides information on the product but not the instrinsic properties of the sulphonate
Executive summary:

Stability analyses of the test material was conducted in corn oil from all dose concentrations (1, 30, 100, and 200 mg/ml). Three 5 ml samples from each concentration were obtained and stored at ambient temperature. Two of the samples from each concentration (one each for the day 4 and day 11 stability analyses) were shipped, in appropriately labeled glass vials with Teflon-lined lids, via overnight courier at ambient temperature to one of the sponsoring company's testing lab. The remaining samplesfrom each level weremaintained at SLI under ambient condition until the conclusion of the study. Test article stability was confirmed by analysing these samples for test material concentration on days 4 and 11 post-preparation after storage at ambient temperature. The average results of the day 0 homogeneity analyses were used as the baseline (day 0) value for the stability analyses. All samples were analyzed fro calcium, an element present at known concentrations in the test material. Percent differences in measured versus baseline values at 10, 30, 100, and 200 mg/ml dose concentration were 3.2, 2.2, 1.4, and 2.1, respectively, in the 4 -day study and 6.5, 1.1, 0.7, and 1.5, respectively, in the 11 -day study. The mean percent differences of all concentration for the 4 -Day and 11 -Day observations were 2.25% and 2.29%, respectively. The test material was considered stable in corn oil.