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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 23 NOV 1976 to 26 NOV 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
Deviations:
not specified
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation

Test material

Constituent 1
Reference substance name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide
EC Number:
229-355-1
EC Name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide
Cas Number:
6486-23-3
IUPAC Name:
2-[(4-chloro-2-nitrophenyl)diazenyl]-N-(2-chlorophenyl)-3-oxobutanamide

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1,5-2,0 kg
- Housing: single
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm, Germany), ad libitum
- Water: tap water, ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped/intact or clipped/scarified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg
Duration of treatment / exposure:
24 h
Observation period:
48 h after end of exposure
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- Type of wrap if used: PVC foil, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p. 27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Remarks on result:
other: intact and scarified
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effect
Remarks on result:
other: intact and scarified
Irritant / corrosive response data:
Erythema and edema scores immediately after exposure were 0 as well as at later time points.
The same results were observed with scarified skin

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not irritating to skin under these test conditions. This conclusion is legitimate even though the applied testing regime differs from today's standard methods, as no skin responses were observed in 6/6 animals 24 and 48 h after exposure, which lasted 20 h longer than required by OECD TG 404.
Executive summary:

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 500 mg test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Neither erythema nor edema were noted 24 and 48 h after end of exposure. The test material is not irritating to skin under these test conditions.