Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: Unpublished data of "Berufsgenossenschaft der chemischen Industrie" cited in ´Toxikologische Bewertung; Ausgabe 05/90; 1,5-Naphthylendiamin; Berufsgenossenschaft der chemischen Industrie´).
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Unpublished data of "Berufsgenossenschaft der chemischen Industrie" cited in ´Toxikologische Bewertung; Ausgabe 05/90; 1,5-Naphthylendiamin; Berufsgenossenschaft der chemischen Industrie´). .
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
other: Unpublished data of "Berufsgenossenschaft der chemischen Industrie" cited in ¿Toxikologische Bewertung; Ausgabe 05/90; 1,5-Naphthylendiamin; Berufsgenossenschaft der chemischen Industrie¿).
Title:
Unnamed
Year:
1988

Materials and methods

Principles of method if other than guideline:
Method: other
GLP compliance:
not specified
Remarks:
Unpublished data of "Berufsgenossenschaft der chemischen Industrie" cited in ´Toxikologische Bewertung; Ausgabe 05/90; 1,5-Naphthylendiamin; Berufsgenossenschaft der chemischen Industrie´).
Type of assay:
other: DNA-binding assay

Test material

Constituent 1
Chemical structure
Reference substance name:
1,5-naphthylenediamine
EC Number:
218-817-8
EC Name:
1,5-naphthylenediamine
Cas Number:
2243-62-1
Molecular formula:
C10H10N2
IUPAC Name:
1,5-naphthylenediamine
Details on test material:
IUCLID4 Test substance: other TS: purity 98.8 %

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
ca.220 g body weight.

Administration / exposure

Route of administration:
oral: unspecified
Duration of treatment / exposure:
24 h
Frequency of treatment:
single dose
Post exposure period:
24 h after oral application the livers were prepared
Doses / concentrations
Remarks:
Doses / Concentrations:
100 mg/kg (radiolabelled substance = 3.6 mCi/kg)
Basis:

No. of animals per sex per dose:
2 male rats
Control animals:
not specified

Examinations

Tissues and cell types examined:
other: Unpublished data of "Berufsgenossenschaft der chemischen Industrie" cited in ´Toxikologische Bewertung; Ausgabe 05/90; 1,5-Naphthylendiamin; Berufsgenossenschaft der chemischen Industrie´).

Results and discussion

Test results
Sex:
male

Any other information on results incl. tables

RS-Freetext:
no DNA-binding activity

Applicant's summary and conclusion

Executive summary:

In a DNA binding study 2 male Sprague-Dawley-rats (ca. 220g b.w) recieved a single oral dose of 100 mg/kg (radiolabelled substance = 3.6 mCi/kg) of 1,5 -Naphthylenediamine.

The DNA and Chromatin-protein were isolated, purified and the specific radioactivity was measured. The results were 4,5, respectively 5,9 dpm/mg DNA.

According to the authors no indication for a DNA binding activity of 1,5 -Naphthyleneamin could be found.