Registration Dossier

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:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diallyl Dimethyl Ammonium chloride
- Molecular formula (if other than submission substance): C8H16N.Cl
- Molecular weight (if other than submission substance): 161.68
- Smiles notation (if other than submission substance): C(=C)CN{+}(c)(c)(.Cl{-})CC=C
- InChl (if other than submission substance): 1/C8H16N.ClH/c1-5-7-9(3,4)8-6-2;/h5-6H,1-2,7-8H2,3-4H3;1H/q+1;/p-1
- 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

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
None
Body weight:
Animals showed expected gains in bodyweight over the study period except for one female which showed no gain in bodyweight during the test and one female which showed bodyweight gain during the first week but bodyweight loss during the second week.
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).