Registration Dossier
Registration Dossier
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EC number: 261-491-7 | CAS number: 58909-56-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A study according to the OECD- and EU-methods, including GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (6R-trans)-7-amino-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- EC Number:
- 261-491-7
- EC Name:
- (6R-trans)-7-amino-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-1,2,4-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Cas Number:
- 58909-56-1
- Molecular formula:
- C12H13N5O5S2
- IUPAC Name:
- 7-amino-3-{[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: 7-ACT
Chemical name: (6R, 7R)-7-Amino-3-(2,5-dihydro-2-methyl-5-oxo-6-hydroxy-1,2,4-triazin-3-yl) thiomethyl-ceph-3-em-4-carbonic acid
CAS No.: 58909-56-1
Supplier: Biochemie Ges.m.b.H.
Batch No.: 3201530
Purity: 99.5 % (content related to waterfree substance)
Water content: 1.5 %
Impurities: Heavy metals: < 20 ppm, by-products: < 0.2 % each
Appearance: white powder
pH: 3.97 (1 % aqueous suspension, measured by pH-meter)
Stability of the test substance: stable under conditions of storage
Disintegration: from 180 *C on
Storage: in a refrigerator in the dark
Date of handing over: July 26, 1994
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga. D-97633 Sulzfeld. Germany.
- Weight at study initiation: 2.5 - 2.6 kg
- Housing: single caging.
- Diet: Altromin 2023, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: ca. 19.5 °C
- Humidity: ca. 50 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg test substance, soaked with 1 mL deionized water.
- Duration of treatment / exposure:
- 4 hours.
- Observation period:
- 1; 24; 48, and 72 h after patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Coverage: semi-occlusive with Fixomull Stretch
REMOVAL OF TEST SUBSTANCE: wiped off using wet cellulose tissue.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- There were no general toxic effect noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- 7-ACT is not a primary skin irritant.
- Executive summary:
The EU-method B.4 and the OECD 404 method were used to investigate the possible skin irritant action of 7 -ACT to 3 rabbits.
No skin reactions were seen in none of the rabbits at each of the observation times of 1, 24, 48 and 72 hours. 7 -ACT is therefore not a primary skin irritant.
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