Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Physical & Chemical properties

Water solubility

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
This study was conducted between 22 September 2016 and 09 May 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is considered to be a reliability 1 as it has been conducted according to OECD TG 105 using the column elution method and in compliance with GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
27 July 1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
EC NO. 440/2008 of 30 May 2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
column elution method
Specific details on test material used for the study:
Identification : Formaldehyde, reaction products with benzenamine and 4,4'-methylenebis[phenol]
Appearance/Physical state: Light yellow solid
Batch : AAD1292300
Purity : 100% UVCB
Expiry date : 01 September 2017
Storage conditions: Approximately 4 °C in the dark
Key result
Water solubility:
< 0 g/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
> 5.6 - < 7
Details on results:
Preliminary test:
The preliminary estimate of water solublity was 1.13 x 10^-5 g/L at 20 °C.

Main Test:
Overall result: Less than <6.00 x 10E-05 at 20 °C

Definitive test:

The mean peak areas relating to the standard and sample solutions are shown in the following table.

Table 1

Solution

Mean peak area

Standard 0.0568 mg/L

8.2189 x 104

Standard 0.114 mg/L

2.2221 x 105

Standard 0.284 mg/L

6.5390 x 105

Standard 0.568 mg/L

1.3791 x 106

Standard 0.107 mg/L

2.1645 x105

Standard 1.14 mg/L

2.6405 x 106

Standard 1.07 mg/L

2.4979 x 106

Sample Blank 1

None detected

System A, Sample 1A

7.5337 x 105

System A, Sample 1B

8.2208 x 105

System B, Sample 1A

1.1652 x 106

System B, Sample 1B

1.1921 x 106

Sample Blank 2

None detected

System A, Sample 2A

7.6396 x 105

System A, Sample 2B

7.1447 x 105

System B, Sample 2A

2.1593 x 106

System B, Sample 2B

2.0581 x 106

Sample Blank 3

None detected

System A, Sample 3A

9.9663 x 105

System A, Sample 3B

9.5609 x 105

System B, Sample 3A

2.3342 x 106

System B, Sample 3B

2.3397 x 106

Sample Blank 4

None detected

System A, Sample 4A

1.3374 x 106

System A, Sample 4B

1.3347 x 106

System B, Sample 4A

2.8228 x 106

System B, Sample 4B

2.8877 x 106

Standard 0.550 mg/L

1.3320 x 106

Standard 1.10 mg/L

2.6802 x 106

Standard 1.65 mg/L

4.0322 x 106

Standard 2.20 mg/L

5.3943 x 106

Standard 2.75 mg/L

6.7370 x 106

Standard 1.04 mg/L

2.6033 x 106

Sample Blank 5

None detected

System A, Sample 5A

1.2907 x 106

System A, Sample 5B

1.2109 x 106

System B, Sample 5A

2.8244 x 106

System B, Sample 5B

2.5594 x 106

Standard 0.854 mg/L

2.1078 x 106

Standard 0.818 mg/L

1.9595 x 106

Sample Blank 6

None detected

System A, Sample 6A

2.0717 x 106

System A, Sample 6B

2.0323 x 106

System B, Sample 6A

2.2334 x 106

System B, Sample 6B

2.5607 x 106

Standard 0.810 mg/L

1.8611 x 106

Standard 0.838 mg/L

1.8389 x 106

Sample Blank 7

None detected

System A, Sample 7A

1.4004 x 106

System A, Sample 7B

1.2084 x 106

System B, Sample 7A

1.8995 x 106

System B, Sample 7B

1.9362 x 106

Sample Blank 8

None detected

System A, Sample 8A*

2.9163 x 106

System B, Sample 8A*

4.8258 x 106

*Single analysis for sample 8, reduced volume left in vessels.

The concentration (g/L) of test item in the sample solutions is shown in the following table:

Table 2

Sample number

Sampling time (hour)†

Concentration (g/L)

Solution pH

System A

System B

System A

System B

System A

System B

1

189.50

191.00

2.21 x 10-5

3.26 x 10-5

6.2

6.0

2

213.50

215.00

2.08 x 10-5

5.75 x 10-5

6.0

5.9

3

238.75

240.25

2.72 x 10-5

6.36 x 10-5

5.8

5.7

4

287.50

289.25

3.68 x 10-5

7.75 x 10-5

5.9

5.9

5

310.00

311.75

3.24 x 10-5

6.99 x 10-5

5.6

5.6

6

501.50

503.25

5.38 x 10-5

6.28 x 10-5

6.0

5.9

7

551.50

553.00

3.70 x 10-5

5.44 x 10-5

6.3

6.2

8§

649.50

649.50

8.27 x 10-5

1.37 x 10-4

6.4

7.0

The overall results are shown in the following table:

Table 3

Determination

Mean concentration (g/L)

Standard deviation

A

3.29 x 10-5

1.13 x 10-5

B

5.98 x 10-5

1.42 x 10-5

Overall result:            Less than6.00 x 10-5g/L at 20 °C

 Validation

The linearity of the detector response with respect to concentration was assessed over the nominal concentration range of0.05to1.12mg/Land 0.5to2.75mg/L. The results were satisfactory with a correlation coefficient (r) of ≥0.999being obtained.

Recovery of analysis of the sample procedure was assessed and proved adequate for the test.


†Sampling hours recorded to the nearest ¼ hour.

§Data generated from Sample 8, system A and B not used within statistics, both deemed outlying results by Thompson tau test.

Recovery data is shown in the following table:

Table 4

Nominal concentration

(mg/L)

Recovery range (%)

Mean recovery (%)

5.0 x 10-2

58.0

58.0

2.5 x 10-2

63.6

63.6

5.0 x 10-3

61.2 to 100.2

78.4

Concentrations have been corrected for themeanrecovery of analysisat 5 x 10-3mg/L (78.4%).

Discussion

As the water solubility was determined during the preliminary test to be below 10-2g/L and the test item was a solid, the column elution method was performed.

The method of analysis showed some variability likely due to the low working level. Due to this, not all of the samples fell within ± 30% of the mean as specified in the test guidelines. There was however no obvious issues with the chromatography (e.g. contamination) which would account for the variability, and therefore all of the sample results were included in the overall result.

The two systems gave different results with the slower flow rate showinglowersolubility. Therefore, the result from system B has been reported asa limitresult.

Conclusions:
The water solubility of the test item has been determined to be less than 6.00 x 10^-5 g/L of solution at 20.0 ± 0.5 °C.
Executive summary:

The water solubility and partition coefficient (n-Octanol/Water)of Formaldehyde, reaction products with benzenamine and 4,4'-methylenebis[phenol]have been determined. 

Water Solubility. Less than 6.00 x 10-5g/L of solution at 20.0 ± 0.5 °C, using the column elution method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008 and Method 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995

Description of key information

The water solubility of the test item has been determined to be less than 6.00 x 10-5 g/L of solution at 20.0 ± 0.5 °C.

Key value for chemical safety assessment

Water solubility:
0 g/L
at the temperature of:
20 °C

Additional information

Water Solubility. Less than 6.00 x 10-5g/L of solution at 20.0 ± 0.5 °C, using the column elution method, designed to be compatible with Method A.6 Water Solubility of Commission Regulation (EC) No 440/2008 of 30 May 2008andMethod 105 of the OECD Guidelines for Testing of Chemicals, 27 July 1995