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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
other: experimentakresult on similar substance
Adequacy of study:
key study
Study period:
1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Principles of method if other than guideline:
Pre-incubation test. Screening program: strain TA98 placed in standard plates. Evaluation without metabolic activation.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Reaction products of diazotised 4,4-diaminodiphenylamine-2-sulfonic acid, subsequently coupled with 6-amino-4-hydroxynaphthalene-2-sulfonic acid, further diazotised and coupled with metaphenylendiamine, sodium salts
EC Number:
939-382-7
Molecular formula:
not applicable
IUPAC Name:
Reaction products of diazotised 4,4-diaminodiphenylamine-2-sulfonic acid, subsequently coupled with 6-amino-4-hydroxynaphthalene-2-sulfonic acid, further diazotised and coupled with metaphenylendiamine, sodium salts

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 98
Metabolic activation:
without
Metabolic activation system:
No
Test concentrations with justification for top dose:
Range 20-5000 µg/plates: 20, 100, 500, 2500, 5000 µg/plate
Controls
Untreated negative controls:
yes
Remarks:
DMSO
Positive controls:
yes
Remarks:
NPD

Results and discussion

Test results
Species / strain:
S. typhimurium TA 98
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: 2500-5000 µg/plate

Any other information on results incl. tables

Revertant/plate Quotient
 Dose µg/plate - S9  M DS

-S9

 Negative control

29

29

18

25  6 1.0
20

19

13

24

19 6 0.7
100

26

26

26

26 0 1.0
500

31

29

28

29 1.2
2500

31

30

24

28 4 1.1
5000

32

31

33

32 1 1.3 
Positive control

608

572

666

615  47  24.3 

Applicant's summary and conclusion

Conclusions:
Negative
Executive summary:

Non mutagen; no increase of revertants has been observed.