Registration Dossier
Registration Dossier
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EC number: 281-468-5 | CAS number: 83950-14-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 September 2017 to 26 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate
- EC Number:
- 281-468-5
- EC Name:
- 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate
- Cas Number:
- 83950-14-5
- Molecular formula:
- C24H27N2O.C2H3O2
- IUPAC Name:
- 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate
- Test material form:
- liquid
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, 97633 Sulzfeld, Germany
- Strain: WISTAR rats Crl: WI(Han)
- Females (if applicable) nulliparous and non-pregnant:yes
- Age at study initiation: males 9-10 weeks; females 12-13 weeks
- Weight at study initiation: Males: 235g - 244g; Females 205g - 227g
- Fasting period before study: NA
- Housing: individually in in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice ad libitum
- Water: tap water, sulphur acidified to a pH value of approximately 2.8 ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 10% of the body surface
- % coverage: 10% of the body surface
- Type of wrap if used: gauze-dressing and non-irritating tape and was fixed with an additional dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with aqua ad injectionem
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Clinical signs and irritation (Draize): once within 30 min after dosing, several times upto 4 hours after dosing, daily thereafter
- Body weight: on day 1, 8 and 15
- Necropsy of survivors performed: yes macroscopic examination
- Statistics:
- NA
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: irritation was observed
- Mortality:
- none
- Clinical signs:
- no systemic effects, red discoloration of the skin in all animals
- Body weight:
- within normal limits
- Gross pathology:
- no findings
- Other findings:
- A crust was observed in 3 of 5 male and 1 of 5 female animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the substance is > 2000 mg/kg bw
- Executive summary:
LD50: > 2000 mg/kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle (moistening): no vehicle used
Number of animals: 5 male and 5 female
Duration of exposure: 24 hours
Method: OECD 402, EC 440/2008, Method B.3
Table1: Results
Sex
Dose
(mg/kg bw)Number
of AnimalsNumber
of Intercurrent Deathsmale
2000
5
0
female
2000
5
0
bw = body weight
Signs of systemic toxicity related to dose level used, time of onset and duration:
No treatment-related effects were observed.
Effect on organs (related to dose level):
No treatment-related effects were observed.
Signs of irritation:
No erythema or oedema was observed. A crust was observed in 3 of 5 male and 1 of 5 female animals.
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