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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[4-(aminocarbonyl)phenyl]-4-nitrobenzamide
EC Number:
298-791-2
EC Name:
N-[4-(aminocarbonyl)phenyl]-4-nitrobenzamide
Cas Number:
93839-21-5
Molecular formula:
C14H11N3O4
IUPAC Name:
N-(4-carbamoylphenyl)-4-nitrobenzamide
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 or test system 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.