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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF Nousan 8147 2-1-4
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
EC Number:
700-222-4
Cas Number:
1065519-44-9
Molecular formula:
C22H28N6O7S
IUPAC Name:
N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
Constituent 2
Reference substance name:
No. 408 Yellow
IUPAC Name:
No. 408 Yellow
Details on test material:
- Name of test material (as cited in study report): No. 408 Yellow
- Physical state: yellow powder
- Analytical purity: 98.6%
- Purity test date: 07 November 2008
- Lot/batch No.: 081105-1
- Expiration date of the lot/batch: 04 November 2009
- Stability under test conditions:
- Storage condition of test material: room temperature, dark, sealed container
- Other: Source: TOYO INK MFG. CO. LTD.; pH of 33% w/v dispersion was 9.3

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd., Bicester
- Age at study initiation: 12 - 13 weeks
- Weight at study initiation: 2.19 - 2.43 kg
- Housing: individually
- Diet (e.g. ad libitum): Global Diet TRB 2930C (Harlan Teklad, Bicester, UK), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21
- Humidity (%): 40 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): only moistened with water


VEHICLE
- Amount(s) applied (volume or weight with unit): 1 ml for moistening
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 30 x 20 mm area on the dorsum
- Type of wrap if used: The dose was spread uniformly over the designated area and then covered by a dense gauze patch (30 x 20 mm) on Day 1. This in turn was covered by a larger gauze patch (40 x 40 mm) and an open weave, elasticated adhesive compression bandage which was wrapped firmly around the torso to secure the applied dose and patch in the correct position. The dressing was considered to be semi-occlusive.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, treated skin was lightly brushed clean of any solid residues and swabbed with cotton wool moistened with water.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: yellow staining of test site
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: yellow staining of test site
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
other: yellow staining of test site
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritant / corrosive response data:
Yellow staining of the test site was noted throughout the study (due to colouring of skin by test substance), but this did not preclude evaluation of the dermal reactions. No dermal response to treatment was observed in any animal throughout the observation period.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

Conclusion:

The test article did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC or to the criteria of GHS.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information