Registration Dossier
Registration Dossier
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EC number: 473-370-8 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 October 2007 to 14 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF
- Version / remarks:
- 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 473-370-8
- EC Name:
- -
- Cas Number:
- 13304-62-6
- Molecular formula:
- C10 H11 N O
- IUPAC Name:
- N-benzylprop-2-enamide
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 Deutschland, Sulzbach, Germany
- Strain: Crl:WI (outbred, SPF quality)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: males 280-314 g; females 180-208 g
- Housing: individually (Macrolon MIII) saw dust bedding, paper as enrichment
- Diet: Pelleted Rodent Diet ad libitum (SM R/M-Z SSNIFF Soest Germany)
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4-23.1 ˚C
- Humidity (%): 42-68%
- Air changes (per hr): ca 15/h
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: males 25 cm2; females 18 cm2
- % coverage: 10%
- Type of wrap if used: surgical gauze patch wrapped with aluminium foil and Coban elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/kg - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males + 5 females
- Details on study design:
- - Duration of observation period following administration: 14 days
- Bodyweight: on day 1 (pre-dose), 8 and 15
- Necropsy of survivors performed: yes
- Mortalith: twice daily
- Clinical signs: several times on day 1, daily thereafter - Statistics:
- NA
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: lethargy, hunched posture, shallow respiration, piloerection, chromodacryorrhoea (snout), ptosis and hypothermia (recovery between day 3 and 6) In 3 females scales and/or scabs at the application site during the observation period
- Gross pathology:
- no abnormalities
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:
In an acute dermal toxicity study 5 rats/sex were exposed to the substance via the dermal route under occlusion during 24 hours at 2000 mg/kg bw (vehicle propylene glycol).
During the 14 day observation period none of the animals died. Clinical signs included lethargy, hunched posture, shallow respiration, piloerection, chromodacryorrhoea (snout), ptosis and hypothermia (recovery between day 3 and 6). In 3 females scales and/or scabs at the application site were seen during the observation period. There was no effect on body weight and the macroscopic examination did not show any abnormalities. The LD50 of the substance is >2000 mg/kg bw.
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