Registration Dossier
Registration Dossier
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EC number: 417-440-8 | CAS number: 2516-92-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- yes
- Remarks:
- The complete product name is : GU 10-415 (CXA-541S)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane
- EC Number:
- 417-440-8
- EC Name:
- 1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane
- Cas Number:
- 2516-92-9
- Molecular formula:
- C28 H50 N2 O6
- IUPAC Name:
- bis(1-hydroxy-2,2,6,6-tetramethylpiperidin-4-yl) decanedioate
- Details on test material:
- Identification code (lab) = TKA 40075
Constituent 1
- Specific details on test material used for the study:
- CXA-5415
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: bred at the laboratory
- Females (if applicable) nulliparous and non-pregnant: yes
- Age: Young adult
- Weight at study initiation: 206 to 269 g
- Fasting period before study: no
The rats were kept in an animal room under conventional laboratory conditions on a 12 hour/day light cycle. The air conditioning system (approximately 15 air changes per hour) maintained a temperature of 22 ± 2°C and a relative humidity of 55 ± 10%. The rats were individually housed in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France). They were acclimatized for at least 5 days before exposure.
Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) and water were provided ad libitum.
- Acclimation period: at least 5 days
IN-LIFE DATES: From: April 19, 1995 To: May 3, 1995
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10% of the body surface
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): 4 ml/kg body weight
- Concentration (if solution): 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80 - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg body weight
- 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:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms; daily for 14 days
Body weight: immediately before application and on days 7 and 14
Necropsies: The animals were submitted to a gross necropsy at the end of the observation period.
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 occurred in this study.
- Clinical signs:
- other: No signs of acute dermal toxicity were observed in this study.
- Gross pathology:
- At necropsy, no deviations from normal morphology were found.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the OECD 402 test, GU 10-415 does not have to be classified for acute dermal toxicity (LD 50 > 2000 mg/kg bw).
- Executive summary:
Upon an acute dermal administration of 2000 mg/kg to males and females (Limit test) and a 14 day post-treatment observation period, the following LD5O was determined for TKA 40075.
LDSO in male rats:
LDSO in female rats:greater than 2000 mg/kg body weight
LDSO in rats of both sexes:greater than 2000 mg/kg body weight
greater than 2000 mg/kg body weight
No signs of acute dermal toxicity were observed in this study. At autopsy, no deviations from normal morphology were found.
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