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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
2002-04-18 - 2002-05-31
Reliability:
2 (reliable with restrictions)
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 analysis 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 analysis) were shipped, in appropriately liability 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.
GLP compliance:
yes
Remarks:
No further information available.

Test material

Constituent 1
Reference substance name:
115733-09-0
Cas Number:
115733-09-0
IUPAC Name:
115733-09-0
Constituent 2
Reference substance name:
Benzenesulfonic Acid, C14-24-Branched And Linear Alkyl Derivs., Calcium Salts
IUPAC Name:
Benzenesulfonic Acid, C14-24-Branched And Linear Alkyl Derivs., Calcium Salts
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): TSD101B
- Description: Dark brown liquid

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

Percent 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:
Observation during an experimental result from a repeated dose study (28-days, oral route, rats). The test substance was found to be stable in corn oil.
Executive summary:

Stability analysis 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 analysis) 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 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 analysis were used as the baseline (Day 0) value for the stability analysis. 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.