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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
carcinogenicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: read across, no information on test material and purity, very briefly documented

Data source

Reference
Reference Type:
publication
Title:
Lack of Toxicity and Carcinogenicity of Some Commonly Used Cutaneous Agents
Author:
Stenbaeck et al
Year:
1974
Bibliographic source:
TOXICOLOGY AND APPLIED PHARMACCLOGY 30, 7-13 (1974)

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
p-aminobenzoic acid
IUPAC Name:
p-aminobenzoic acid
Constituent 2
Reference substance name:
4-aminobenzoic acid
EC Number:
205-753-0
EC Name:
4-aminobenzoic acid
Cas Number:
150-13-0
IUPAC Name:
4-aminobenzoic acid

Test animals

Species:
mouse
Strain:
Swiss Webster
Sex:
female
Details on test animals or test system and environmental conditions:
age: 7 weeks
randomized
housed in plastic cages with commercial bedding, 10 per cage
commercial diet, ad libitum
water ad libitum

Administration / exposure

Route of administration:
dermal
Vehicle:
acetone
Details on exposure:
TEST SITE
- Area of exposure: dorsal skin
- 1 inch-square

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.02 ml
- Concentration (if solution): 1, 5 and 10 %
- Constant volume or concentration used: yes
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
live span
Frequency of treatment:
twice a week
Doses / concentrations
Remarks:
Doses / Concentrations:
1, 5, 10%
Basis:

No. of animals per sex per dose:
50/mouse/dose
Control animals:
yes, concurrent no treatment
yes, concurrent vehicle

Examinations

Sacrifice and pathology:
Complete autopsies were performed on all animals. The skin from all animals, all grossly observed tumors and other lesions in the lungs, livers, kidneys, etc., from treated as well as control groups were studied histologically. Formalin-fixed paraffin-embedded specimens were cut and stained with hematoxylin-eosin and other stains when needed.
Statistics:
The statistical significance of the results was evaluated using the methods presented by Armitage (1971).

Results and discussion

Results of examinations

Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed

Effect levels

Dose descriptor:
NOAEL
Sex:
female
Basis for effect level:
other: None of the chemicals studied produced a statistically significant increase in skin tumor incidence.
Remarks on result:
not determinable
Remarks:
no NOAEL identified. Effect type:carcinogenicity (migrated information)

Applicant's summary and conclusion