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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 29.07.1986 to 01.08.1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
p-toluidine
EC Number:
203-403-1
EC Name:
p-toluidine
Cas Number:
106-49-0
Molecular formula:
C7H9N
IUPAC Name:
p-toluidine
Details on test material:
- Name of test material (as cited in study report): p-toludine
- Physical state: solid (brown-white crystalline product)
- Analytical purity: >99%
- Storage condition of test material: at 22 °C in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: about 3.5 months
- Weight at study initiation: 2.6-3.2 kg
- Housing: animals were individually caged in full air-conditioned rooms
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät-rabbits (Altromin-GmbH, Lage/Lippe, Germany) and hay as well (about 15 g daily) ad libitum
- Water (e.g. ad libitum): deionized, chlorinated water from automatic drinking trough


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light):12 hrs dark/ 12 hrs light


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: isotonic NaCL solution
Controls:
not specified
Amount / concentration applied:
Concentration: 500 mg
Duration of treatment / exposure:
4 hour(s)
Observation period:
30-60 minutes, and 24, 48, and 72 hours after removal of the plaster
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: the dorsal areas of the trunk
- % coverage: 2.5 cm²
- Type of wrap if used: band-aid with 2.5 cm² cellulose overlay, covered with a semiocclusive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with lukewarm tap water
- Time after start of exposure: after the exposure time (4 hours)


SCORING SYSTEM: according to Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30-60 min; 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30-60 min; 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30-60 min; 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 30-60 min; 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 30-60 min; 24-72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 30-60 min; 24-72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
During the all duration of the test the rabbits did not show any irritation effect of the skin

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

Dr. Hofmann (1986)

The primary irritation potential of p-toluidine in skin was tested with a test according to OECD guideline 404.

3 rabbits were dosed with 500 mg of toluidine on the dorsal areas of the trunk . The area of treatment was covered with a band-aid with 2.5 cm² cellulose overlay, covered with a semiocclusive bandage.

The animals were exposed for 4 hours. After the expsoure the test substance was removed with lukewarm tap water. The evaluation was perfomed at 30 -60 minutes, and 24, 48 and 72 hours after the removal of of the bandage.

During the all duration of the test the rabbits did not show any irritation effect of the skin.