Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report Date:
1959

Materials and methods

Principles of method if other than guideline:
Suspension of test substance in water, ethanol, and oil (30% w/v) was applied to a 2.5 x 2.5 cm patch (0.5-1 ml) and placed on the clipped and intact skin of two white Vienna rabbits for 1 min, 5 min, 15 min (TS in water and ethanol) and 20 hours (TS in water, ethanol, and oil) under occlusive conditions.
By the end of short-term exposure (1-15 min), the skin was irrigated and skin reaction was recorded up to five days after application of the test substance. Cutaneous reaction were described according to Draize criteria.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4,4´-Diamino-3,3´-dimethyl-diphenylmethan = o-"Toluidinbase", destilled, grinded
- Physical state: crystalline powder, creme-like coloured
- Analytical purity: 99-100%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
other: 20 h test: water, ethanol (96%) or oil; time test: water or ethanol (96%)
Controls:
no
Amount / concentration applied:
Concentration: 30 %
TEST MATERIAL
- Amount(s) applied: ca. 1 mL
- Concentration (if solution): 30%
Duration of treatment / exposure:
Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h
Observation period:
at least 5 d, until complete recovery
Number of animals:
2 per treatment
Details on study design:
TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (37°C; approx. 1 ml)

REMOVAL OF TEST SUBSTANCE
- Washing:
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol 50% (mild detergent) was used as concentrate, followed by 50% solution in water
Experiment 2: No washing was done after the 20 h treatment.

SCORING SYSTEM: Descriptive scores were converted into Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
20 h exposure, vehicle: water
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Remarks on result:
other: yellow staining within the first three days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
20 h exposure, vehicle: ethanol
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Remarks on result:
other: yellow staining within the first three days
Irritation parameter:
erythema score
Basis:
mean
Remarks:
20 h exposure, vehicle: oil
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Remarks on result:
other: yellow staining within the first three days
Irritation parameter:
edema score
Basis:
mean
Remarks:
20 h exposure; all tested vehicles
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Short time exposure (1-15 min): Independent from the solvent used, no cutaneous reaction was observed at the end of the exposure period. 

Long time exposure (20 hours): Test substance caused yellowish skin coloration perceptible for up to three days in all tested animals. Slight, barely perceptible cutaneous reaction was reported 24 hours after application of the test substance in one animal. Scaling was observed in one animal 4 days after application of the test substance. Five days after application of the test substance all animals were free of cutaneous reactions and staining

Applicant's summary and conclusion