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Toxicological information

Carcinogenicity

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Administrative data

Endpoint:
carcinogenicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Rat skin carcinogenesis by topical applications of some azo dyes
Author:
Fare G.
Year:
1966
Bibliographic source:
Cancer Res 26: pp.2406-8
Reference Type:
secondary source
Title:
4-Aminoazobenzene. BUA-Stoffbericht 217
Author:
Beratergremium für Altstoffe (BUA).
Year:
1998
Bibliographic source:
BUA der Gesellschaft dt. Chemiker, S. Hirzel Wissenschaftliche Verlagsgesellschaft, Stuttgart.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 451 (Carcinogenicity Studies)
Deviations:
yes
Remarks:
only one dose used, only one sex used, only 6 animals used
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Aminoazobenzene: Recristallized prior to use

Test animals

Species:
rat
Strain:
other: Albino outbred from own breeding
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: own breeding
- Age at study initiation: 3 to 4 months old
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
dermal
Vehicle:
acetone
Details on exposure:
TEST SITE
- Area of exposure: between scapulae
- % coverage: no data
- Type of wrap if used: no data
- Time intervals for shavings or clipplings: Hair was shaved every 2 months in the early stages but much more frequently when tumors began to appear.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 ml
- Concentration (if solution): 0.2% solution
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): 1 ml
- Concentration (if solution): 100%


USE OF RESTRAINERS FOR PREVENTING INGESTION: no
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
mean time of treatment 123 weeks
Frequency of treatment:
twice per week
Post exposure period:
no post exposure period
Doses / concentrations
Remarks:
Doses / Concentrations:
1 ml of 0.2% solution in aceton
Basis:
analytical conc.
No. of animals per sex per dose:
6 male animals
Control animals:
yes, concurrent vehicle
Positive control:
no

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No data

DERMAL IRRITATION (if dermal study): Yes

BODY WEIGHT: No data

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Details on results:
Result (carcinogenicity): positive

Effect levels

Dose descriptor:
conc. level:
Effect level:
0.2 other: %
Sex:
male
Basis for effect level:
other: Skin tumors
Remarks on result:
other: Effect type: carcinogenicity (migrated information)

Any other information on results incl. tables

6 male rats treated twice weekly with Aminoazobenzene:

Mean time 1st lesion noted: 97th week

Mean length of treatment: 123 weeks

Tumor incidence: 0/6 ear duct; 6/6 skin

Total yield of skin tumors in group, postmortem: 5 epidermoid cysts; 4 squamous carcinoma; 8 basal carcinoma; 2 anaplastic carcinoma; 1 squamous papiloma; 3 miscellaneous

Applicant's summary and conclusion