Registration Dossier
Registration Dossier
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EC number: 500-303-2 | CAS number: 115340-85-7 1 - 4.5 moles ethoxylated
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-10-31 to 2018-01-26
- 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)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
- EC Number:
- 500-303-2
- EC Name:
- 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
- Cas Number:
- 115340-85-7
- IUPAC Name:
- 4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: R-127. Lot 170825
- Expiration date of the lot/batch: 2019-07-26
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: soluble
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: nVivos Pte Ltd
9 Perahu Road,
Um Chu Kang, Singapore 718793
- Age at study initiation: young adult
- Weight at study initiation: 200 - 300 g
- Fasting period before study: none
- Housing: OptiMICE Caging Systems for rats
- Diet (e.g. ad libitum): Altrom in Maintenance Diet #1324 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22 °C
- Humidity (%): 30 - 70 %
IN-LIFE DATES: From: 2017-10-26 To: 2017-11-21
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: < 10 % of entire body surface
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): 432 - 472 mg with femalles; 488 - 540 mg with males
- Concentration (if solution): 2000 mg/kg bw
- Constant volume or concentration used: yes (constant concnetration) - 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: observations: 30', 1, 2 an 4 h, then daily. Weighing: once per week
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: No abnormality was observed on all animals during the necropsy.
- Gross pathology:
- No abnormality was observed on all animals during the necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condition of this study and based on CLP for acute dermal toxicity hazard categories, the test item - 4, 4'lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825 is considered as Unclassified, the LD50 value of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, is more than 2000 mg/kg body weight.
- Executive summary:
The acute dermal toxicity of 4, 4'lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, was examined ina guideline study according to OECD 402.
Under the condition of this study and based on CLP for acute dermal toxicity hazard categories, the test item - 4, 4'lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825 is considered as Unclassified, the LD50 value of the test item - 4, 4'-lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, Lot No: 170825 is more than 2000 mg/kg body weight.
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