Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Justification for type of information:
Acidic pH suggests substasnce is Corrosive. Acute toxicity should not be conducted for animal welfare reasons.
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 FEB 2010 to 9 NOV 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
no
Principles of method if other than guideline:
A modified shake flask method was used due to the miscibility issues during the preliminary test.
GLP compliance:
yes
Type of method:
flask method
Key result
Water solubility:
> 3.2 - < 109 g/L
Conc. based on:
test mat.
Temp.:
30 °C
pH:
> 1.1 - < 2
Details on results:
The substance+ contains components of differing solubility's with some that are highly water soluble and others that are insoluble in water.

Solubility Data in Double Distilled Water

Empower sequence

Time at 30°C (h)

pH

Water solubility (g/L) for the different components

1

2

3

4

5

6

7

8

Wat sol 1/1

72

1.15

121.337198

4.319104

9.253571

57.816957

17.364575

24.838698

3.083244

7.379179

Wat sol 1/2

118.574615

4.604040

9.702959

57.231721

17.408307

23.399703

2.818549

6.130783

Wat sol 2/1

1.17

113.414097

4.616720

9.698897

59.470359

17.690547

23.697769

3.357619

4.467738

Wat sol 2/2

111.103757

4.591120

9.755235

59.707105

17.573097

24.461391

3.189871

4.115053

Wat sol 3/1

48

1.24

111.664698

4.544294

9.667858

57.153139

17.430543

22.769146

3.191545

7.278253

Wat sol 3/2

108.863743

4.531065

9.235040

57.386382

16.940904

22.498112

2.956469

7.840833

Wat sol 4/1

1.22

103.017131

4.447034

9.453493

58.247427

17.220243

22.975569

4.351804

6.008563

Wat sol 4/2

103.816730

4.514593

9.270085

58.354612

17.746479

23.084906

3.063403

6.019195

Wat sol 5/1

24

1.26

105.281349

4.508196

9.801496

58.251510

17.053431

23.070927

3.099800

4.723000

Wat sol 5/2

102.137493

4.422346

9.754621

58.134522

17.391539

22.924026

3.173515

5.269974

Wat sol 6/1

1.24

104.817783

4.591908

9.919605

60.173027

17.802809

23.865584

3.074666

7.163433

Wat sol 6/2

107.140057

4.495398

9.813308

59.613141

18.082690

23.856611

2.717002

5.637709

Mean (g/L)

 

 

 

 

109.3

4.515

9.611

58.46

17.48

23.45

3.173

6.003

Std Dev

 

 

 

 

6.169

0.08692

0.2419

1.037

0.3247

0.7072

0.4090

1.224

RSD (%)

 

 

 

 

5.65

1.925

2.517

1.774

1.858

3.015

12.889

20.398

Conclusions:
Interpretation of results (migrated information): other: contains components of differing solubility's with some that are highly water soluble and others that are insoluble and others that are insoluble in water.
The substance contains components of differing solubility's with some that are highly water soluble and others that are insoluble in water. Mean solubility values ranged from ca 3.2 to 109.3 g/L, with one component proving insoluble in water.
Executive summary:

The calibration lines were established linearly with no weighting. The resultant pH was 1.2.

The temperature of the 30°C water bath incubation bath was constant at a temperature of 30.1°C over the test period. The temperature of the 20°C incubation bath ranged between 30.0[1] and 19.7°C with an average temperature of 19.8°C over the test period.

The data broadly support the results obtained from the partition coefficient evaluation that MK92K contains components of differing solubilities with some that are highly water soluble and others that are insoluble in water. Mean solubility values ranged from ca 3.2 to 109.3 g/L, with one component (peak 9) proving insoluble in water.


[1]     The water bath was outside of the specified limits for ca 37 minutes whilst the water bath cooled from 30°C.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion