Registration Dossier
Registration Dossier
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EC number: 276-594-2 | CAS number: 72361-35-4
Toxicological information
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- from 2009-05-18 to 2009-06-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters
- EC Number:
- 290-754-9
- EC Name:
- 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters
- Cas Number:
- 90218-76-1
- Molecular formula:
- C33H51O6 to C39H66O6
- IUPAC Name:
- tris(mixed decyl and octyl)benzene-1,2,4-tricarboxylate
- Reference substance name:
- 1,2,4-Benzenetricarboxylic acid, decyl octyl ester
- EC Number:
- 268-007-3
- EC Name:
- 1,2,4-Benzenetricarboxylic acid, decyl octyl ester
- Cas Number:
- 67989-23-5
- Molecular formula:
- C10H22O.xC9H6O6.xC8H18O
- Details on test material:
- - Name of test material (as cited in study report): 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters
- Substance type: pure active substance
- Physical state: liquid
- Stability under test conditions: no data
- Storage condition of test material: ambient temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l., San Pietro al Natisone (UD), Italy
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: 275.0 ± 3.7 g (mean weight males), 215.6 ± 10.9 g (mean weight females)
- Housing: Polycarbonate cages measuring 42.5x26.6x18 cam with stainless steel mesh lid and floor
- Diet (e.g. ad libitum): 4 RF 18 ad libitum, supplied by Mucedola S.r.l., Settimo Milanese (MI), Italy
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 25
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2009-06-3 To: 2009-06-18
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal surfaces of the trunk
- % coverage: 10 %
- Type of wrap if used: A patch of surgical gauze covered by a strip of synthetic film was placed over the treated site and the whole assembly held in place by encyrcling the trunk of the animal with a lenght of elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, by gentle swabbing of the skin with cotton wool soaked with lukewarm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Aliquots were weighed accordingly to the body weight of each animal measured prior to dosing, no further details mentioned - Duration of exposure:
- 24 hours
- 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: Mortality and morbidity twice daily, clinical signs were recorded on dosing, approx. 1, 2 and 4 hours after dosing and daily thereafter, body weights were recorded on the day of allocation (day -1), days 1, 8 and 15 (day of necropsy)
- Necropsy of survivors performed: yes
- Other examinations performed: no - Statistics:
- not performed
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
- Clinical signs:
- other: no clinical signs were observed
- Gross pathology:
- At necropsy examination performed on all animals at termination of the study red areas (multiple, pinpoint) in the right lobe of the thymus were noted in a single female animal. No abnormalities were found in the ranimnif animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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