Registration Dossier
Registration Dossier
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EC number: 230-993-8 | CAS number: 7398-69-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented report of a guideline study conducted to 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)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diallyldimethylammonium chloride
- EC Number:
- 230-993-8
- EC Name:
- Diallyldimethylammonium chloride
- Cas Number:
- 7398-69-8
- Molecular formula:
- C8H16N.Cl
- IUPAC Name:
- diallyldimethylammonium chloride
- Details on test material:
- - Name of test material (as cited in study report): Diallyl Dimethyl Ammonium chloride
- Physical state: clear colourless liquid
- Impurities (identity and concentrations): NaCl 1.4%
- Composition of test material, percentage of components: DADMAC 61.6 % in water
- Purity test date: 2008-01-18
- Lot/batch No.: GV8A0445
- Storage condition of test material: approximately 4°C in the dark
- Specific gravity : 1.027
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: 8 to 12 weeks of age
- Weight at study initiation: at least 200g
- Fasting period before study: No
- Housing: suspended solid-floor polypropylene cages furnished with wood flakes.
- Diet : ad libitum; 2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK)
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): of 19 to 25°C
- Humidity (%): 30 to 70% respectively
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material
- Time after start of exposure: 24-hour
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.17 ml/kg
- Constant volume or concentration used: no - Duration of exposure:
- 24 hours
- Doses:
- 3247 mg/kg of DADMAC 61.6% in water equivalent to 2000 mg active ingredient/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
- Frequency of observations and weighing: Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- No (limit test)
Results and discussion
- Preliminary study:
- No
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 3 247 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: equivalent to 2000 mg active ingredient/kg bw
- Mortality:
- None
- Clinical signs:
- other: None
- Gross pathology:
- No abnormalities were noted at necropsy
- Other findings:
- Very slight erythema was noted at the treatment sites of all females one day after dosing, in three females two and three days after dosing and persisted in one female four days after dosing. There were no signs of dermal irritation noted in males during the study.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 3247mg/kg body weight (equivalent to 2000 mg active ingredient/kg bodyweight).
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