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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Toxicology and carcinogenesis studies of p-chloroaniline hydrochloride (CAS no. 20265-96-7) in F344/N rats and B6C3F1 mice (gavage studies)
Author:
NTP
Year:
1989
Bibliographic source:
U.S. department of health and human services Public Health Service National Institutes of HealthNational toxicology program Technical Report Series No. 351

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only Salmonella strains tested. No E.coli strain or TA 102
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
4-chloroanilinium chloride
EC Number:
243-656-5
EC Name:
4-chloroanilinium chloride
Cas Number:
20265-96-7
IUPAC Name:
4-chloroanilinium chloride
Constituent 2
Reference substance name:
p-chloroaniline hydrochloride
IUPAC Name:
p-chloroaniline hydrochloride
Details on test material:
- Name of test material (as cited in study report): p-chloroniline hydrochloride
- Analytical purity: >99%

Method

Target gene:
his+
Species / strain
Species / strain / cell type:
other: TA 97, TA 98, TA 100, TA 1535, and/or TA 1537
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague Dawley rat or Syrian hamster liver)
Test concentrations with justification for top dose:
SRI international: 0, 33, 100, 333, 1000, 1666 µg/plate;
Microbiological Associates: 0, 33, 100, 333, 1000, 1500, 2000 µg/plate;
Case Western Reserve University: 0, 10, 33, 100, 333, 1000, 3333 µg/plate
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene was used on all strains (+S9). 4-nitro-o-phenylenediamine was used with TA98, sodium-azide was used with TA100 and TA1535, and 9-aminoacridine was used with TA97 and TA1537 (-S9)
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours


NUMBER OF REPLICATIONS: Each test consisted of triplicate plates of concurrent positive and negative controls and of at least five doses of the study chemical.



DETERMINATION OF CYTOTOXICITY
- Method: no data


Evaluation criteria:
Positive response was defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination. An equivocal response was defined as an increase in revertants which was not dose related, not reproducible, or of insufficient magnitude to support a determination of mutagenicity. A response was considered negative when no increase in revertant colonies was observed after chemical treatment.

Results and discussion

Test resultsopen allclose all
Species / strain:
other: TA97, TA98, TA100, TA1535, and/or TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
Study performed at Case Western Reserve University
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
other: TA 97, TA100, TA 1535, or TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
TA 97 at high dosis (-S9). Study performed at SRI International.
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
other: T98
Metabolic activation:
without
Genotoxicity:
negative
Remarks:
Study performed at SRI international
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
Study performed at SRI international
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
other: TA97, TA98, TA100, TA1535, and/or TA1537
Metabolic activation:
without
Genotoxicity:
negative
Remarks:
Study performed at Microbiological Associates
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
Weakly positive with + S9 hamster at 5% and 30%; positive + S9 hamster at 10%; positive with +S9 rat between 5-30%. Study performed at Microbiological Associates
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with
Genotoxicity:
positive
Remarks:
+S9 (hamster) at 30%
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
other: TA97, TA98, TA100, TA1535, and/or TA1537
Metabolic activation:
without
Genotoxicity:
negative
Remarks:
Study performed at Microbiological Associates
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive with metabolic activation strain TA98 with rat or Syrian hamster S9 (2 laboratories), strain TA100 (1 laboratory) with hamster S9 only.
Executive summary:

NTP (1989)

p-Chloroaniline has been tested for mutagenicity with a method similar to OECD guideline 471 with restrictions (Only Salmonella strains tested. No E.coli strain or TA 102) in three different laboratories.

Mutagenic activity for p-chloroaniline was observed by two laboratories in strain TA98 in the presence of Aroclor 1254-induced male Sprague Dawley rat or Syrian hamster S9, and one laboratory noted an increase in revertant colonies in strain TA100 in the presence of hamster S9 only.

No mutagenic activity was reported in strains TA97, TA1535, or TA1537.