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Diss Factsheets

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 04 OCT 1983 to 07 OCT 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study (OECD TG 404) GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

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:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
EC Number:
236-852-7
EC Name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
Cas Number:
13515-40-7
Molecular formula:
C17H15ClN4O5
IUPAC Name:
2-[(4-chloro-2-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide
Test material form:
solid: nanoform, no surface treatment

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- strain: Hoe: HIMK (SPFWiga)
- Source: Hoechst AG, in-house SPF-breeding
- Weight at study initiation: 2.6-2.9 kg
- Housing: individually
- Diet: Altromin 2123 for rabbit husbandry (Altromin, Lage/Lippe), ad libitum
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 1 mL polyethylene glycol 400
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of an adhesive tape in contact with skin site
- Type of wrap: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
None of the animals showed any skin reaction. Erythema and edema scores were 0 at all time points of observation.
Other effects:
Yellow discolouration of treated skin sites.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to skin under the test conditions.
Executive summary:

The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No erythema or edema were visible (score 0) in any of the 3 animals tested during the observation period (up to 72 hours after end of the 4 h exposure period). The treated skin sites showed a yellow discoloration.