Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-Nitrobenzoylaminobenzamid TTR

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG breeding colony
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.4 - 3.9 kg
- Housing: fully air conditioned rooms, single cages (battery housing)
- Diet: Altromin 2123 rabbit diet, ad libitum plus 15 g hay per day
- Water: deionized and chlorinated water, ad libitum

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
500 mg mixed with 0.7 ml of 0.9% NaCl-solution
Duration of treatment / exposure:
4 hours
remnant test substance was removed with lukewarm tap water
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: plaster and bandage

REMOVAL OF TEST SUBSTANCE
- Washing : lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
erythema: 0 - 4
edema: 0 - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 175, 181, 182 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
edema score
Basis:
animal: # 175, 181, 182 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Irritant / corrosive response data:
all scores 0
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Not irritating to skin
Executive summary:

Skin irritation/corrosion of N-(4-carbamoylphenyl)-4-nitrobenzamide (500 mg mixed with 0.7 ml of physiol. saline) was tested in New Zealand Whiter rabbits according to OECD 404. During the observation period of 72 h no signs of irritation/corrosion were observed at any time.