Registration Dossier
Registration Dossier
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EC number: 226-939-8 | CAS number: 5567-15-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 SEP 1996 to 10 SEP 1996.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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
- Reference substance name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]
- EC Number:
- 226-939-8
- EC Name:
- 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]
- Cas Number:
- 5567-15-7
- Molecular formula:
- C36H32Cl4N6O8
- IUPAC Name:
- 2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide]
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chemical pharmaceutical factory, Dr. K. Thomae, Biberach
- Weight at study initiation: 2.5-3.2 kg
- Housing: individually
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g pasted with 0.8 ml polyethylene glycol 400 (Riedel-de Haen) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of surgical plaster (Beiersdorf)
- Type of wrap: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with warm tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD TG 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 7 days after exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 72 h after exposure.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 7 days after exposure.
- Irritant / corrosive response data:
- From one hour up to 3 days after removal of the patches the treated skin of the animals showed very slight up to well defined erythema. 7 days after removal of the patches no signs of skin irritation were observed. Very slight edema was noted in 2/3 animals one hour after exposure. No edema were noted at any other time point.
- Other effects:
- The skin surface of the animals was dry, rough and light yellow discoloured.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test item is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
- Executive summary:
The test item material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. Very slight up to well defined erythema were observed in every animal, fully reversible within seven days. Very slight edema were observed in 2/3 animals only one hour after exposure, fully reversible within one day. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
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