Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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 07 SEP 1976 to 23 SEP 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: FDA guideline (minor deviations from OECD guideline)
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 (Federal register 38, No. 187, 27.9.1973, p.27019)
Deviations:
no
GLP compliance:
no
Remarks:
study was performed previous to GLP implementation

Test material

Constituent 1
Reference substance name:
N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide
EC Number:
258-221-5
EC Name:
N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide
Cas Number:
52846-56-7
IUPAC Name:
2-[(4-nitrophenyl)diazenyl]-3-oxo-N-(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)butanamide

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: ERKA 8300 (Futtermittelwerke Robert Koch oHG, Hamm, Germany), ad libitum
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped intact and clipped scarified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
Duration of treatment / exposure:
24 h
Observation period:
48 h after removal of patch with observation time points immediately, 24 h and 48 h after removal of the patch.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: erythema and edema scores (0-4)

Skin was evaluated immediately, 24 h and 48 h after removal of the patch. Mean values of the readings 24 and 48 h after removal are reported in the results table.

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: clipped intact and clipped 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: clipped intact and clipped scarified
Irritant / corrosive response data:
Immediately after removal of patch no erythema score could be determined due to pigment overlay. Edema score at this time point was 0 for all animals. No edema or eryhthema were seen 24 and 48 h after removal of the patch (score 0).
Results on scarified skin showed identical results.

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. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.
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 0.5 g test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Immediately after removal of patch no erythema score could be determined due to pigment overlay. No erythema were seen at the later observation time points. No edema were seen at any time point (score 0). The test item is not irritating under these test conditions.