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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 vivo

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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary citation

Data source

Reference
Reference Type:
secondary source
Title:
ECB (2000): Ethyl Corporation, "Genetic Toxicology Micronucleus Test (MNT)", Pharmakon Laboratories, Scranton, Pennysylvania, December, 1979.
Author:
European Commission - European Chemicals Bureau
Year:
2000
Bibliographic source:
ECB (2000): Ethyl Corporation, "Genetic Toxicology Micronucleus Test (MNT)", Pharmakon Laboratories, Scranton, Pennysylvania, December, 1979.

Materials and methods

Principles of method if other than guideline:
Method: other: micronucleus assay
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
6-ethyl-2-toluidine
EC Number:
246-309-6
EC Name:
6-ethyl-2-toluidine
Cas Number:
24549-06-2
Molecular formula:
C9H13N1
IUPAC Name:
2-ethyl-6-methylaniline
Details on test material:
IUCLID4 Test substance: as prescribed by 1.1 - 1.4 (ECB IUCLID dataset 2000)

Test animals

Species:
mouse
Strain:
other: other
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
no data
Details on exposure:
The test substance was administered ip once daily for two days
Duration of treatment / exposure:
24 and 48 hours
Frequency of treatment:
daily for two days
Post exposure period:
6 h after after second dose
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 10, 80 mg/kg bw
Basis:

No. of animals per sex per dose:
4 males and 4 females per dose group
Control animals:
yes
Positive control(s):
0.5 mg/kg triethylenemelamine

Examinations

Tissues and cell types examined:
polychromatic erythrocytes
Details of tissue and slide preparation:
no data
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

RS-Freetext:
The results were considered negative based on the inability of the  chemical to produce a statistically significant increase in the number of  micronuclei per 1000 polychromatic erythrocytes in the treated versus the  control groups

Applicant's summary and conclusion

Executive summary:

The test substance 2 -ethyl-6 -methylaniline (MEA) was evaluated in the in vivo micronucleus assay using CF-1 mice. The results were considered negative based on the inability of the MEA to produce a statistically significant increase in the number of micronuceli per 1000 polychromatic erythrocytes in the treated animals versus the control group (ECB 2000).