Registration Dossier
Registration Dossier
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EC number: 220-135-0 | CAS number: 2638-94-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 September 2016 - 28 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4'-azobis[4-cyanovaleric] acid
- EC Number:
- 220-135-0
- EC Name:
- 4,4'-azobis[4-cyanovaleric] acid
- Cas Number:
- 2638-94-0
- Molecular formula:
- C12H16N4O4
- IUPAC Name:
- 4,4'-azobis[4-cyanovaleric] acid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 150726 (Test item No.: 16/0252-1)
- Expiration date of the lot/batch: 25 July 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: male animals: approx. 8 weeks, female animals: approx. 12 weeks
- Weight at study initiation: 199 - 247 g
- Housing: Single housing
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx.. 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: about 40 cm²
- % coverage: at least 10% of the body surface
- Type of wrap: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).
REMOVAL OF TEST SUBSTANCE
- Washing: rinsing of the application site with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2454 mg/kg bw
- Constant concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount applied: 6.14 mL/kg bw
- Concentration: 40 g / 100 mL - Duration of exposure:
- 24 h
- Doses:
- 2454 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: several times on the day of application and at least once during each workday thereafter; weighing: before application (day 0), weekly thereafter and on the last day of observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 454 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: main constituent (corrected for purity, 100 % purity)
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination. No local effects were observed.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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