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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1989
Report date:
1989

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:
4-methoxy-3-nitro-N-phenylbenzamide
EC Number:
202-572-9
EC Name:
4-methoxy-3-nitro-N-phenylbenzamide
Cas Number:
97-32-5
Molecular formula:
C14H12N2O4
IUPAC Name:
4-methoxy-3-nitro-N-phenylbenzamide

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, company breeding colony
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.1 - 3.4 kg
- Housing: AC, single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen ad libitum, 15 g hay per day
- Water (e.g. ad libitum): deionised, chlorinated water from an automatic water dispenser ad libitum

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 500 mg of test material mixed with 0.25 ml physiol. saline

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 ml physiol. saline
- Concentration (if solution): 500 mg of test material mixed with 0.25 ml physiol. saline
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: adhesive plaster covered by a bandage

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

SCORING SYSTEM:
Erythema: 0-4
Edema: 0-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 12, 13, 14 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable owing to lack of effects
Irritation parameter:
edema score
Basis:
animal: # 12, 13, 14 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable owing to lack of effects
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritant, not corrosive to skin

Findings do not meet criteria for classification according to Regulation (EC) No 1272/2008.

Executive summary:

Skin irritation/corrosion was tested according to OECD guideline 404. Following this protocol the test item (0.5 g mixed with 0.25 ml physiol. saline) was applied to the intact skin of three New Zealand White rabbits under semi-occlusive conditions for four houres. The scoring of skin reactions was performed 1, 24, 48 and 72 h after removal of the test item. No skin reactions, neither erythema nor edema, were observed at any time point (all scores 0). No signs of sytemic toxicity were reported.