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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance was dertermined be non-mutagenic and not bacteriotoxic in an Ames test.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October - November 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Year 1991 or earlier
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Version / remarks:
Year 1991 or earlier
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9 mix
Test concentrations with justification for top dose:
20, 100, 500, 2500 and 5000 µg/plate
Vehicle / solvent:
water
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
10 µg for all S. typhimurium strains, 60 µg for E.coli with activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-methyl-N'-nitro-N-nitrosoguanidine
Remarks:
5 µg for TA 100 and TA 1535 without activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine
Remarks:
10 µg for TA 98 without activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine chloride monohydrate
Remarks:
100 µg for TA 1537 without activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
10 µg for E.coli without activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 37 °C for 20 min
- Exposure duration: 48 h at 37 °C

NUMBER OF REPLICATIONS: each 3 plates 2 times

DETERMINATION OF CYTOTOXICITY
- Method: reduction of background growth
Evaluation criteria:
Substance is positive in bacterial test if:
- causes doubling of spontaneous mutation rate (control)
- has a dose-response relationship
- has reproducible results
Statistics:
No data
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
Complete solubility of the test substance in aqua dest.
No bacteriotoxic effects observed.
Remarks on result:
other: standard plate test and preincubation test

Standard plate test

Dose (µg/plate) Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli
TA1535 TA100 TA1537 TA98 WP2 uvrA
Results without S9
Aqua dest 14 ± 2 92 ± 12 8 ± 1 22 ± 3 26 ± 2
20 15 ± 3 91 ± 6 6 ± 1 21 ± 3 23 ± 3
100 12 ± 3 93 ± 10 8 ± 3 22 ± 3 22 ± 4
500 13 ± 2 102 ± 10 10 ± 1 18 ± 7 23 ± 6
2500 19 ± 2 78 ± 12 12 ± 3 20 ± 7 24 ± 7
5000 13 ± 3 81 ± 2 9 ± 3 21 ± 2 18 ± 6
MNNG (5) 1917 ± 100 1787 ± 225
AAC (100) 506 ± 98
NPD (10) 736 ± 71
ENNG (10) 417 ± 37
Results with S9
Aqua dest 16 ± 3 101 ± 16 11 ± 5 35 ± 2 30 ± 3
20 14 ± 3 107 ± 6 15 ± 1 34 ± 5 33 ± 2
100 11 ± 1 96 ± 6 10 ± 2 31 ± 5 30 ± 6
500 15 ± 3 81 ± 15 13 ± 2 31 ± 8 33 ± 2
2500 15 ± 2 86 ± 13 15 ± 1 33 ± 2 31 ± 3
5000 15 ± 1 98 ± 13 17 ± 3 35 ± 3 33 ± 6
2-AA (10) 183 ± 22 1273 ± 206 158 ± 14 no value
2-AA (60) 138 ± 15

Preincubation test

Dose (µg/plate) Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E. coli
TA1535 TA100 TA1537 TA98 WP2 uvrA
Results without S9
Aqua dest 15 ± 3 109 ± 6 8 ± 2 25 ± 3 22 ± 3
20 14 ± 3 105 ± 12 9 ± 1 19 ± 4 22 ± 2
100 13 ± 3 101 ± 9 9 ± 1 21 ± 1 21v1
500 13 ±  108 ± 9 9 ± 1 19 ± 2 22 ± 2
2500 18 ± 5 101 ± 12 8 ± 3 22 ± 2 21 ± 4
5000 16 ± 5 85 ± 2 11 ± 4 23 ± 1 19 ± 2
MNNG (5) 1029 ± 42 1095 ± 107
AAC (100) 459 ± 51
NPD (10) 979 ± 106
ENNG (10) 613 ± 22
Results with S9
Aqua dest 15 ± 4 113 ± 8 12 ± 2 35 ± 6 23 ± 3
20 14 ± 3 97 ± 6 13 ± 3 35 ± 2 20 ± 1
100 14 ± 2 123 ± 5 12 ± 4 35 ± 6 24 ± 1
500 14 ± 4 106 ± 13 9 ± 2 36 ± 6 23 ± 4
2500 15 ± 1 101 ± 12 12 ± 3 34 ± 3 22 ± 2
5000 14 ± 2 105 ± 3 11 ± 2 31 ± 2 23 ± 1
2-AA (10) 156 ± 11 908 ± 54 106 ± 10 709 ± 114
2-AA (60) 69 ± 17
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Genetic toxicity in vitro

The study tested the mutagenicity of the test substance. The study was conducted according to GLP and OECD TG 471 and 472. Ames test and reverse mutation assay were performed. Both were done in the standard plate test and in the preincubation test with and without the addition of a metabolizing system obtained from rat liver (S-9 mix) using the Salmonella strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli WP2 uvrA. No bacteriotoxic effects were observed. All tests and strains showed a negative effect. Therefore the test substance was considered non mutagenic in those tests under the corresponding conditions.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result based on an Ames test the substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/218.