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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant . The reliability is estimated to be at level 2 at a minimum.
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant . The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Data obtained from the ECHA as the data is older than 12 years old
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: data was obtained from the ECHA in accordance with Article 25 of REACH, the data provided did not state a method.
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)
EC Number:
403-720-7
EC Name:
A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)
IUPAC Name:
403-720-7
Constituent 2
Reference substance name:
Orasol Black RLI
IUPAC Name:
Orasol Black RLI
Details on test material:
We do not have any details on the test material as the data was obtained from the ECHA using the 12 year rule
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Due to the following reasons we wish to read across to the substance containing EC number 403-720-7:

The test substance and analogue substance (403-720-7) have very similar structural properties, the only difference between the two substances are that the counter cations are different. Valifast black contains a mixture of both ammonium and sodium cations whereas the analogue material (403-720-7) contains only tert C12-C14. alkylammonium ions. The ammonium and sodium ions present in Valifast black are unlikely to be toxic and their contribution to the toxicity of Valifast black is trivial. The anion components are the same for both substances and these appear to be key for the toxicity of the substance.

The relative density and the water solubility of the two substances are very similar as shown in the read across proposal (please find the read across proposal attached in section 13).

The analogue material EC 403-720-7 is not expected to accumulate in the environment. Due to the slightly higher log Pow (4.94 - 4.97) for the test material (Valifast Black 3810) the test substance has the potential to accumulate into the environment. As the test substance has a higher potential to acumulate into the environment, read across is still appropriate.

Neither the test material or the analogue material are classified with regards to the acute oral toxicity study. However both substances did provide a positive response both with and without metabolic activation in the Ames study.

Due to the reasons stated above I believe that read across is appropriate.

Sampling and analysis

Analytical monitoring:
not specified

Test solutions

Vehicle:
not specified

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
not specified
Water media type:
not specified

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
not specified

Applicant's summary and conclusion

Validity criteria fulfilled:
not specified
Conclusions:
The analogue substance produced the following result for the short term test to aquatic invertebrates:
Daphnia: EC50 >1000 mg/l
Executive summary:

The analogue substance produced the following result for the short term test to aquatic invertebrates:

Daphnia: EC50 >1000 mg/l

The justifications for using read across can be found in a report that has been attached in section 13.