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Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Predates implementation of GLP and/or development of study guidelines, available as unpublished report, limitations in design and/or reporting acceptable with restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Six albino rabbits were used, the hair was clipped from the back of each of these animals. The test material was applied as 40% suspension in 1% aqueous carboxymethyl cellulose to each of three rabbits with intact skin and to each of three rabbits with abraided skin. The volume of the test material applied was approximately 2.0 mL per rabbit, which was spread and rubbed evenly onto the skin and into the abrasions once a day on five days of the week, over a period of 14 days.

GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminobenzenesulphonic acid
EC Number:
204-473-6
EC Name:
3-aminobenzenesulphonic acid
Cas Number:
121-47-1
Molecular formula:
C6H7NO3S
IUPAC Name:
3-aminobenzene-1-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): Metanilic Acid Cake, Ba 38/76, TR 76-415 (M53740; UM 44)

Test animals

Species:
rabbit
Strain:
other: albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 1.89 - 2.11 kg

Administration / exposure

Type of coverage:
not specified
Vehicle:
other: 1% aqueous carboxymethyl cellulose
Details on exposure:
TEST SITE
- Area of exposure: the back
- Coverage: 12 x 18 cm per rabbit; covered approximately 10% of the total body surface of a rabbit
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 mL per rabbit
- Concentration (if solution): 40% suspension in 1% aqueous carboxymethyl cellulose.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
14 days
Frequency of treatment:
Once a day on five days of the week.
Doses / concentrations
Remarks:
Doses / Concentrations:
40% suspension in 1% aqueous carboxymethyl cellulose
Basis:

No. of animals per sex per dose:
6 animals (3 with intact skin, 3 with abraided skin)
Control animals:
not specified
Details on study design:
no data

Examinations

Observations and examinations performed and frequency:
DERMAL IRRITATION (if dermal study): Yes
BODY WEIGHT: Yes
CAGE SIDE OBSERVATIONS: Yes
URINALYSIS: Yes
Sacrifice and pathology:
no data

Results and discussion

Results of examinations

Details on results:
The compound produced no signs of local irritation. The abraided areas had healed nearly completely at the end of the two-week period. The gain in body weight of rabbits was above normal. (average body weight gain intact skin group 0.73 kg, abraided skin group 0.61 kg). Compound is brown in color, and stained the skin and fur light brown. The urine of all animals had a brownish color, indicating that a portion of the compounds applied was absorbed. Signs of systemic intoxication were not noted.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion