Registration Dossier
Registration Dossier
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EC number: 244-479-6 | CAS number: 21615-47-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Mar - 17 Apr 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Ammonium undecafluorohexanoate
- EC Number:
- 244-479-6
- EC Name:
- Ammonium undecafluorohexanoate
- Cas Number:
- 21615-47-4
- Molecular formula:
- C6H4F11NO2
- IUPAC Name:
- 2,2,3,3,4,4,5,5,6,6,6-Undecafluorohexanoic acid, ammonium salt (1:1)
- Test material form:
- solid
- Remarks:
- White powder
Constituent 1
- Specific details on test material used for the study:
- - storage: at room temperature in a shaded and air-tight container in a desiccator
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD)
- Remarks:
- SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hino Breeding Centers (Charles River Laboratories), Hino, Japan
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 7 weeks (males) and 9 weeks (females)
- Weight at study initiation: 250.4 – 254.4 g (males) and 218.5 – 232.5 g (females)
- Housing: Individually in stainless steel cages (260 x 380 x 180 mm) with mesh-floor
- Diet: MF pelleted diet (Oriental Yeast), ad libitum
- Water: chlorinated tap water (chloric level maintained from 3 to 5 ppm by addition of sodium hypochloride (Purelox) to tap water), ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27 Mar 2018 To: 17 Apr 2018
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5 x 5 cm clipped skin of the dorsal area
- Type of wrap if used: The test material was applied on a non-woven gauze which was covered and fixed by elastic adhesive bandage (SILKYTEX5, ALCARE).
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed using purified water and absorbent cotton.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- Concentration: 20% (w/v)
- Dose volume: 10 mL/kg bw
VEHICLE
- Amount applied: 10 mL/kg bw
- Lot/batch No.: PC171219 - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs and mortality continuously for 10 min after the administration, 30 min and 3 h after the administration and once daily during Days 1 to 14 after the administration. Individual body weights were recorded prior to administration as well as 1, 7 and 14 days post-dose.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study period.
- Clinical signs:
- 2000 mg/kg bw: All animals showed slight decreased spontaneous locomotion after the application and 3 h after administration. All effects were reversible within Day 2 of the observation period.
- Body weight:
- Body weight gains were within the expected ranges in males and females of this species and strain during the study period.
- Gross pathology:
- 2000 mg/kg bw: Pelvic dilation of the right kidney was observed in 1/5 males.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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