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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:
experimental study
Adequacy of study:
supporting study
Study period:
1987-02-20 - 1987-03-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
in accordance with: Ames, B. N., McCann, J. and Yamasaki, E. (1975) Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian-Microsome Mutagenicity Test. Mutat. Res. 31, 347-364.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
p-Isononylphenol
IUPAC Name:
p-Isononylphenol
Details on test material:
- Name of test material (as cited in study report): p-Isononylphenol
- Substance type: pure active substance
- Physical state: liquid
- Analytical purity: n.a.
- Impurities (identity and concentrations): n.a.
- Composition of test material, percentage of components: n.a.
- Lot/batch No.: 206/870211
- Expiration date of the lot/batch: n.a.
- Stability under test conditions: n.a.
- Storage condition of test material: n.a.

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver
Test concentrations with justification for top dose:
10, 25, 50, 100, 250, 500, 1000, 5000 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Aminoanthracene

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

1a) with S9 activation
  control control DMSO 25 µg 50 µg 100 µg 250 µg 500 µg 10µg Aminoanthracen
TA 98 42 23 24 33 30 41 27 0
  24 26 37 33 43 36 43 0
  19 26 47 37 32 31 41 0
mean 28 25 36 34 35 36 37 0
sd 12 1,7 11,5 1,9 6,9 4,9 8,7 0
TA 100 28 27 29 34 31 49 19 852
  22 35 30 36 25 31 20 828
  30 41 40 40 34 26 29 741
mean 27 34 33 37 30 35 23 807
sd 4,1 7 6 3 4,5 12 5,5 58,4
1535 6 3 10 10 9 2 7 0
  14 12 16 13 8 9 7 0
  6 16 15 15 13 12 5 0
mean 8 10 13 13 12 7 6 0
sd 4,6 6,6 3,2 2,5 2,6 5,1 1,1 0
1537 16 10 8 8 14 6 52 0
  12 13 14 14 14 8 59 0
  5 12 12 17 14 4 8 0
mean 11 11 11 13 14 6 39 0
sd 5,5 1,5 3 4 0 1,9 27,6 0
1538 26 18 26 25 41 34 34 0
  32 25 46 25 28 32 22 0
  28 42 29 32 29 16 24 0
mean 28 28 33 27 32 27 26 0
sd 3 12,3 10,7 4 7,2 9,8 6,4 0
1b) without S9 activation
TA 98 15 27 33 32 18 26 21 0
  24 34 28 37 32 21 23 0
  19 24 26 35 29 15 17 0
mean 19 28 29 34 26 20 20 0
sd 4,5 5,1 3,6 2,5 7,2 5,5 3 0
TA 100 38 27 40 31 20 10* 5* 0
  33 34 36 44 35 16 12 0
  58 29 42 29 24 14 11 0
mean 43 30 39 34 26 13 9 0
sd 13,2 3,6 3 8,5 7,7 3 3,7 0
1535 9 10 13 19 10 0* 0* 0
  13 14 10 10 7 0 0 0
  13 10 14 6 7 0 0 0
mean 11 11 12 11 9 0 0 0
sd 2,3 2,3 2 6,6 1,7 0 0 0
1537 6 4 10 8 0* 0* 0* 0
  10 9 12 5 0 0 0 0
  7 6 8 6 0 0 0 0
mean 7 6 10 6 0 0 0 0
sd 2 2,5 2 1,5 0 0 0 0
1538 17 21 22 17 17 10 11* 0
  26 19 23 23 27 13 5 0
  21 13 22 13 16 16 6 0
mean 21 17 22 17 20 13 7 0
sd 4,5 4,1 0,5 5 6 3 3,2 0
2a) with S9 activation
TA 98 18 18 20 21 13 13 7* 0
  25 24 20 18 16 22 7 0
  20 21 21 12 14 21 9 0
mean 21 21 20 17 14 18 7 0
sd 3,6 2,9 0,5 4,5 1,5 4,9 1,1 0
TA 100 25 27 24 42 11* 23* 5* 41
  29 26 40 27 7 9 6 21
  22 26 20 21 3 7 6 40
mean 25 26 28 30 7 13 5 34
sd 3,5 0,5 10,5 10,8 3,9 8,7 0,5 11,2
1535 11 10 12 10 101* 1* 0* 0
  11 10 9 6 181 2 3 0
  6 6 9 3 165 1 1 0
mean 9 8 10 6 155 1 1 0
sd 2,8 2,3 1,7 3,5 47,3 0,5 1,5 0
1537 9 11 14 8 4* 5* 2* 0
  10 13 11 12 3 4 4 0
  6 4 8 22 3 2 0 0
mean 8 9 11 14 3 3 2 0
sd 2 4,7 2,5 7,2 0,5 1,5 1,9 0
1538 16 23 22 29 12 11* 8* 0
  16 25 14 13 25 9 7 0
  25 37 13 17 10 14 7 0
mean 19 28 16 19 15 11 7 0
sd 5,1 7,5 4,9 2,3 8,1 2,5 0,5 0
2b) without S9 activation
TA 98 39 27 39 36 52 26 33 0
  26 28 29 25 52 27 31 0
  29 44 22 33 33 28 37 0
mean 31 22 29 32 45 27 33 0
sd 6,8 9,5 8 6,6 10,9 1 3 0
TA 100 31 20 27 23 16 30 150* 453
  24 19 30 24 32 19 89 375
  31 12 22 18 25 11 121 442
mean 28 17 26 21 24 20 118 423
sd 4 4,3 4 3,2 8 9,5 31 42,2
1535 7 15 10 18 9 118* 225* 0
  11 11 7 16 12 194 36 0
  12 12 10 12 11 42 84 0
mean 10 12 9 15 10 114 118 0
sd 2,6 2 1,7 3 1,5 71 96,8 0
1537 13 6 10 9 20 80* 52* 0
  11 10 3 7 10 7 43 0
  11 7 16 10 11 53 108 0
mean 11 7 9 8 13 46 67 0
sd 1,1 2 6,5 1,5 5,5 36,9 35,2 0
1538 16 13 32 34 31 38 153* 0
  20 36 32 17 29 25 126 0
  36 36 29 20 29 26 103 0
mean 24 28 33 23 29 29 127 0
sd 10,5 13,2 5,1 9 1,1 7,2 25 0
*=toxic effect

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

p-Isononylphenol does not show mutagenicity in this Test. Toxic effects start at concentrations of 250 µg/dish. The study is not well documented and deviate from the current OECD Guideline.

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