Registration Dossier
Registration Dossier
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EC number: 279-899-9 | CAS number: 82089-64-3
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14-03-2017 to 05-04-2017
- 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)
- Version / remarks:
- adopted 24 Februrary 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- (ethyl acetoacetato-O1',O3)(pentane-2,4-dionato-O,O')[propane-1,3-diolato(2-)-O,O']titanium
- EC Number:
- 279-899-9
- EC Name:
- (ethyl acetoacetato-O1',O3)(pentane-2,4-dionato-O,O')[propane-1,3-diolato(2-)-O,O']titanium
- Cas Number:
- 82089-64-3
- Molecular formula:
- C14H22O7Ti
- IUPAC Name:
- 13-ethoxy-8,10,15-trimethyl-1λ³,5λ³-dioxa-7λ³,11λ³,12,16-tetraoxa-6-titanaspiro[5.5⁶.5⁶]hexadeca-7,10-diene-6,6,6,6-tetrakis(ylium)-1,5,9,14-tetraide
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study: no
- Housing: individually in the initial test, and individually in the "main test" during the exposure time and in groups of four, by sex, for the remainder of the study; suspended solid floor polypropylene cages furnished with woodflakes
- Water and Diet: free access to mains drinking water and food (2014C Teklad Global Rodent diet)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approx. 10% of total body surface area
- Type of wrap if used: a piece of 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): the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with dimethyl sulphoxide to remove any residual test item.
- Time after start of exposure: 24h
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:
- 1 (initial test)
4 ("main test") - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 30 min, 1, 2 and 4 hours, subsequently once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal reactions
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy
- Other findings:
- Dermal reactions:
Yellow colored staining, not preventing evaluation of dermal responses, was noted at the test sites of five animals 1 day after dosing.
Very slight erythema was noted at the test sites of the initial two treated animals 1 and 2 days after dosing and persisted in the initial treated male 3 and 4 days after dosing.
There were no signs of dermal irritation noted at the test sites of the additional group of eight animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
The test item does not meet the criteria for classification according to CLP Regulation. - Executive summary:
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.
The test item does not meet the criteria for classification according to CLP Regulation.
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