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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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28 Jun 2006 to 17 Jul 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404), GLP compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

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:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydro-5-oxo-1-phenyl-1H-pyrazole-3-carboxylate]
EC Number:
228-788-3
EC Name:
Diethyl 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydro-5-oxo-1-phenyl-1H-pyrazole-3-carboxylate]
Cas Number:
6358-87-8
Molecular formula:
C36H28Cl2N8O6
IUPAC Name:
diethyl 4,4'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(5-oxo-1-phenyl-4,5-dihydro-1H-pyrazole-3-carboxylate)
Test material form:
solid: nanoform

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands, Horst, Netherlands
- Age at study initiation: 10-11 weeks (males), 9-10 weeks (females)
- Weight at study initiation: 1854 to 1972 g
- Housing: individually in stainless steel cages
- Diet (ad libitum): Provimi Kliba 3418 rabbit diet (Provimi Kliba, Kaiseraugst, Switzerland)
- Water (ad libitum): community tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: purified water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance moistened with 0.5 ml of purified water
Duration of treatment / exposure:
4 h
Observation period:
14 days after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 4 x 4 cm
- Type of wrap if used: surgical gauze patch, covered by semi-occlusive dressing

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

SCORING SYSTEM:
according to guidelines; observation time points: 1 h, 24 h, 48 h, 72 h, 7 d, 10d, 14d after removal of the dressing

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- No edema or erythema were observed at any time point after removal of the dressing; observation continued for 14 days due to red staining of the skin caused by the red colored test item.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item was not irritating.
Executive summary:

An OECD guideline 404 (Acute dermal irritation / corrosion) study was performed in three rabbits. The animals were dermally exposed to 0.5 g of the test item for 4 h under semiocclusive coverage. After removal of the test substance the exposed area was oberved for 14 days. There were no signs of skin irritation in any animals at any time point. The test substance was not irritating to skin under the conditions of the test.