Benzenesulfonic acid, mono-C16-24-alkyl derivs., calcium salts , overbased including distillates (petroleum), hydrotreated heavy paraffinic C10-C50

Stability in organic solvents and identity of relevant degradation products

Link to relevant study record(s)

Reference

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.

Reason / purpose for cross-reference:

reference to same study

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 substance stable:

yes

Transformation products:

not measured

Table 1. 4-Day and 11-Day Stability Study
Day	Dose Concentration mg/ml	Measured Concentration wt% Calcium	Baseline Value^awt% 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

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.

Description of key information

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.

Additional information

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 labelled glass vials with Teflon-lined lids, via overnight courier at ambient temperature to one of the sponsoring company's testing lab. The remaining samples from each level were maintained 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 for 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.