Registration Dossier
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EC number: 260-913-7 | CAS number: 57712-94-4
Hydrolysis
Administrative data
Link to relevant study record(s)
- Endpoint:
- hydrolysis
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH : Please see attached Read Across supporting document in Section 13 which includes the following:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
3. ANALOGUE APPROACH JUSTIFICATION
4. DATA MATRIX - Reason / purpose for cross-reference:
- read-across source
- Transformation products:
- no
- Details on hydrolysis and appearance of transformation product(s):
- Based on read across from an analogous substance, there would not be any expected hydrolytic products of the test substance.
- Key result
- Remarks on result:
- other: Based on read across to an analogous substance, no hydrolysis expected: Precipitation occurred for analogue substance.
- Remarks:
- Based on read across to an analogous substance, no hydrolysis expected.
- Conclusions:
- The test substance is hydrolytically stable.
- Executive summary:
Based on read across to N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-1-amine, the test substance (which has the same structure but with the 2-ethylhexyl group replaced with a tridecyl group) is expected to be hydrolytically stable.
The potential of an analogue substance to undergo hydrolysis was investigated in accordance with Method C.7 – Degradation – Abiotic Degradation: Hydrolysis as a Function of pH, Council regulation (EC) No 440/2008, Published in OJ No L 142/518 May 2008.
A preliminary test (Tier 1) was performed at 50 ± 0.5 °C and pH 4.0, 7.0, and 9.0. During the preliminary test a decrease of more than about 10 % of the test substance concentration was observed. Therefore the test substance was considered to be hydrolytically unstable and Tier 2 was performed.
Tier 2 was carried out at 22, 50 and 60 °C and buffered solution with a nominal value of pH 4, 7 and 9.
At the end of Tier 2, precipitation of the test substance was observed in all of the tested buffered solutions. The precipitated test substance adhered to glass. Analyses from Tier 3 confirmed the presence of no degradation products in all of the tested buffered solutions.
On the basis of these observations, the decrease of the test substance during the whole testing procedure was not caused by hydrolysis. Therefore the analogue substance is considered to be hydrolytically stable. Based on the similarity in structure, Solvent Red 19T is also predicted to be hydrolytically stable.
Reference
Description of key information
The test substance is considered to be hydrolytically stable.
Key value for chemical safety assessment
Additional information
The potential of an analogue substance to undergo hydrolysis was investigated in accordance with Method C.7 – Degradation – Abiotic Degradation: Hydrolysis as a Function of pH, Council regulation (EC) No 440/2008, Published in OJ No L 142/518 May 2008.
A preliminary test (Tier 1) was performed at 50 ± 0.5 °C and pH 4.0, 7.0, and 9.0. During the preliminary test a decrease of more than about 10 % of the test substance concentration was observed. Therefore the test substance was considered to be hydrolytically unstable and Tier 2 was performed.
Tier 2 was carried out at 22, 50 and 60 °C and buffered solution with a nominal value of pH 4, 7 and 9.
At the end of Tier 2, precipitation of the test substance was observed in all of the tested buffered solutions. The precipitated test substance adhered to glass. Analyses from Tier 3 confirmed the presence of no degradation products in all of the tested buffered solutions.
On the basis of these observations, the decrease of the test substance during the whole testing procedure was not caused by hydrolysis. Therefore the analogue substance is considered to be hydrolytically stable. Based on the similarity in structure, Solvent Red 19T is also predicted to be hydrolytically stable.
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