Registration Dossier
Registration Dossier
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EC number: 288-927-9 | CAS number: 85940-40-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- EC Number:
- 288-927-9
- EC Name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- Cas Number:
- 85940-40-5
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with pentaethylenehexamine
- Test material form:
- liquid: viscous
- Details on test material:
- viscous liquid
UVCB
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 - 10 weeks, female animals approx. 12 - 14 weeks
- Weight at study initiation: 200-300g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
- Fasting: 16h before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: September 13, 2012 To: October 2nd, 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal and dorsolaterale parts of the trunk
- % coverage: 10
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing of the application site with luke warm water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.13 ml/kg bw
- Concentration (if solution): 100%
- Constant volume or concentration used: yes
For a better homogeneity the test item will be heated at 40°C for approx. 1 hour. The test item will be administrated hand warm. - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed individually for behaviour changes or signs of toxicity <0.5, 1, 2, 3, 4 and 5 hours after dosing at the day of administration and at least once daily thereafter. Clinical observations were performed at least once each working-day and recorded individually. Individual body weight was determined shortly before test item administration, at weekly intervals thereafter and before the sacrifice of the animals at the end of the observation period. A check for moribund and dead animals was made at least once each work-day.
- scoring: Individual recording of findings 30 - 60 minutes after removal of the semi- occlusive dressing; afterward, at approx. weekly intervals and on the last day of observation.
- Necropsy of survivors performed: yes
- Other examinations performed: On the last day of the observation period, the animals were sacrificed by CO2-inhalation in a chamber with increasing concentrations over time, followed by necropsy and gross-pathological examination. - Statistics:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality observed.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.
- Other findings:
- The following test item-related local effects were recorded during the course of the study:
oVery slight to severe erythema (grade 1 to 4)
o Very slight to severe edema (grade 1 to 4)
o Incrustations
o Scaling
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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