Registration Dossier
Registration Dossier
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EC number: 272-379-2 | CAS number: 68815-51-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay, Labor für biologische Analytik GmbH, 69120 Heidelberg
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
- EC Number:
- 272-379-2
- EC Name:
- 9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
- Cas Number:
- 68815-51-0
- Molecular formula:
- C18 H34 O2 . C4 H12 N2 O
- IUPAC Name:
- 2-(2-aminoethylamino)ethanol; (Z)-octadec-9-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): Kerocrom F 100
- Physical state: Solid (melt)/ brown
- Analytical purity: Approx. 100%
- Lot/batch No.: 09001529U0
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility
- Storage condition of test material: Room temperature; avoid >50°C
Constituent 1
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, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Mean weight at study initiation: male 252 g (244-262), female 216 g (202-228)
- Housing: single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): Tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26
- Humidity (%): 20-80
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 40 cm2
- % coverage: at least 10% of the body surface
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.18 ml/kg bw
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Individual body weights shortly before administration(day 0), weekly thereafter and on the last day of
observation.
- Necropsy of survivors performed: yes, necropsy with gross-pathology examination on the last day of the observation period after sacrifice with CO2 in a chamber with increasing concentrations over time.
- Other examinations performed: clinical signs, body weight,organ weights, evaluation of skin reactions according to Draize, J.H. (1959)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
- Other findings:
- Local effects in males: Skin effects at the application site in the group of the male animals comprised erythema (grade 1), scaling and encrustations and were observed on study day 1 through to study day 13.
Local effects in females: Skin effects at the application site in the group of the female animals comprised erythema (grade 1 or 2), edema (grade 1), scaling and encrustations and were observed on study day 1 through to study day 14.
Any other information on results incl. tables
Under the conditions of this study the median lethal dose (LD50) of Kerocrom F 100 after dermal application was found to be greater than 2000 mg/kg body weight in male and female rats.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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