Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-831-3 | CAS number: 88-44-8
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline used.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 4-aminotoluene-3-sulphonic acid
- EC Number:
- 201-831-3
- EC Name:
- 4-aminotoluene-3-sulphonic acid
- Cas Number:
- 88-44-8
- Molecular formula:
- C7H9NO3S
- IUPAC Name:
- 2-amino-5-methylbenzene-1-sulfonic acid
- Details on test material:
- Aldrich Chemical; purified by recrystalization; purity 99.8% (with moisture 1.03%)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- C57BL
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- Corn oil
- Duration of treatment / exposure:
- single dose; Smears were prepared at 24, 48 and 72 hrs after dosing.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3125 and 5000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 1st experiment: 5 animals per dose per sacrifice date
2nd experiment: 15 males per dose (24 h sacrifice) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
Examinations
- Tissues and cell types examined:
- Bone marrow smears were prepared at 24, 48 and 72 hours after dosing.
- Details of tissue and slide preparation:
- The preparations were stained with polychrome methylene blue and eosin. 1000 Polychromatic erythrocytes per slide were evaluated for the
presence of micronuclei. Approximately 1000 erythrocytes were counted to obtain the cytotoxicity.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
LETHALITY
No mortality on each 5 male and 5 female mice was observed
till 4 days after 5000 mg/kg single dose.
MEAN INCIDENCE OF MICLONUCLEI/1000 CELLS
based on 5 observations:
chemical
dose sex 24hr 48hr 72hr
------------------------------------------------------------
-negative control 20mL/kg male 0.8
1.4 0.8
20mL/kg female 1.4 0.4 0.6
positive control 65mg/kg male
17.0**
65mg/kg female 13.6**
test substance 3125mg/kg male
2.6*
3125mg/kg female 1.0
5000mg/kg male 3.2* 2.8 1.4
5000mg/kg female 1.2 0.8 1.2
------------------------------------------------------------
-* significant increase (p<0.05)
** significant increase (p<0.01)
negative control = corn oil
positive control = Cyclophosphamide
Positive control gave the expected increase in the frequency
of micronucleated polychromatic erythrocytes (MPE).
As a slight increase was observed in above (*), below
confirmation experiment was executed.
based on 15 observations (confirmation experiment in male):
chemical dose sex 24hr
------------------------------------------------------------
-negative control 20mL/kg male 2.5
test substance 3125mg/kg male 2.0
5000mg/kg male 4.2
------------------------------------------------------------
-negative control = corn oil
No significant statistic increase was observed in male.
MEAN PERCENTAGE OF POLYCHROMATIC ERYTHROCYTES
based on 5 observations:
chemical
dose sex
24hr 48hr 72hr
------------------------------------------------------------
-negative control 20mL/kg male 30.0 35.4 36.2
20mL/kg female 32.0 36.8 39.2
positive control 65mg/kg male 30.7
65mg/kg female 30.8
test substance 3125mg/kg male 38.1
3125mg/kg female 34.9
5000mg/kg male 16.2* 28.0 34.1
5000mg/kg female 23.1 29.7 29.7
------------------------------------------------------------
-* significant decrease (p<0.05, means slight cytotoxicity)
negative control = corn oil
positive control = Cyclophosphamide
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The data obtained indicate that this substance is not clastogenic in the mouse micronucleus test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
