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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: other: micronucleus formation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Full, detailed report, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

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

Constituent 1
Reference substance name:
Naphtol AS PH
IUPAC Name:
Naphtol AS PH
Constituent 2
Chemical structure
Reference substance name:
2'-ethoxy-3-hydroxy-2-naphthanilide
EC Number:
202-185-5
EC Name:
2'-ethoxy-3-hydroxy-2-naphthanilide
Cas Number:
92-74-0
Molecular formula:
C19H17NO3
IUPAC Name:
N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 8 weeks
- Weight at study initiation: m: 32,3 g; f: 25,2 g
- Assigned to test groups randomly: yes

- Housing: groups of 5 of 1 sex
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 C
- Humidity (%): 55 +/- 10 %

- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: sesame oil
- Concentration of test material in vehicle: 250 mg/mL, suspension
Details on exposure:
single gavage
Post exposure period:
24 - 48 - 72 h
Doses / concentrations
Remarks:
Doses / Concentrations:
0 or 2500 mg/kg bw.
Basis:
actual ingested
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
cyclophosphamide;
- Route of administration: po
- Doses / concentrations:50 mg/kg bw

Examinations

Tissues and cell types examined:
bone marrow from femur
Details of tissue and slide preparation:
DETAILS OF SLIDE PREPARATION: staining with May-Grünwald and Giemsa

METHOD OF ANALYSIS: microscopy
Evaluation criteria:
per animal: number of micronuclei per 1000 polychromatic cells, number of micronuclei per 1000 normochromatic cells , ratio of polychromatic to normochromatic cells
blind reading, statistical evaluation

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Naphtol AS PH was not mutagenic in the mouse micronucleus test.