Registration Dossier
Registration Dossier
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EC number: 807-422-1 | CAS number: 66918-01-2
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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
- EC Number:
- 807-422-1
- Cas Number:
- 66918-01-2
- Molecular formula:
- C40H78O5
- IUPAC Name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
- Details on test material:
- - Name of test material (as cited in study report): SALACOS 222
- Physical state: liquid
- Analytical purity: > 98%
- Lot/batch No.: 7-2-D
- Expiration date of the lot/batch: 04/10
- Storage condition of test material: room temperature ( 20 +/- 5 °C), light protected
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: males: 8 wks; females: 11 wks
- Weight at study initiation: males: 240-260 n; females: 190-208 g
- Fasting period before study:
- Housing: acclimation period: five per sex in Makrolon type-4 cages with standard softwood bedding; treatment/observation period: individually in Makrolon type-3 cages with standard softwood bedding ('Lignocel', Schill AG, Switzerland)
- Diet (e.g. ad libitum): Provimi Kliba 3433, ad libitum
- Water (e.g. ad libitum): community tap water, ad libitum
- Acclimation period: 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 +/- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: backs of animals, approx. 10 % of total body surface
- % coverage:
- Type of wrap if used: semiocclusive dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm tap water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.18 mL/kg
- Concentration (if solution): test item applied undiluted based on its density
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male / 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability:
acclimatisation: daily
test: 30 min, 1,2 ,3 , and 5 hours after administration on day 1 as well as twice a day during observation period
body weights: day 1, 8, and 15
clinical signs:
acclimatisation: daily
test: 30 min, 1,2 ,3 , and 5 hours after administration on day 1 as well as once a day during observation period
local signs: once a day during observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no statistical analysis was used
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no death occured during the study
- Clinical signs:
- other: no systemic or local signs of toxicity were observed
- Gross pathology:
- no macroscopic findings at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study the LD50 for acute dermal toxicity was determined to be > 2000 mg/kg bw. This value should be considered as reliable and adequate for the classification.
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