Registration Dossier
Registration Dossier
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EC number: 700-316-5 | CAS number: 1155405-88-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1998-09-01 to 1998-09-16
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tri (hexyl, octyl, decyl) citrate
- IUPAC Name:
- Tri (hexyl, octyl, decyl) citrate
- Reference substance name:
- 2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester
- IUPAC Name:
- 2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester
- Reference substance name:
- -
- EC Number:
- 430-290-8
- EC Name:
- -
- IUPAC Name:
- 430-290-8
- Details on test material:
- - Name of test material (as cited in study report): Tri (hexyl, octyl, decyl) citrate
- Substance type: pure active substance
- Physical state: liquid
- Storage condition of test material: room temperature in a closed container
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 218 - 250 g
- Housing: individually kept in Macrolon cages on Altromin saw fiber bedding
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1998-09-01 To: 1998-09-16
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: gauze-dressing and non-irritating tape, fixed with an additional dressing to prevent ingestion
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): 2000 mg/kg bw - 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: clinical examination once a day, weighing prior to application and once a week thereafter
- 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
- Mortality:
- no compound related mortality observed
- Clinical signs:
- other: All animals showed reduced spontaneous activity throughout the contact period. Activity rose immediately after removal of dressing. No clinical signs of toxicity were observed throughout the observation period.
- Gross pathology:
- No test compound related macroscopic necropsy findings were recorded.
- Other findings:
- Necropsy revealed an acute injection of blood vessels in all animals in the abdominal region. This finding was subjected to be due to euthanasia with an overdose of pentobarbital injected intraperitoneally.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
The application of the test item in a dose of 2000 mg/kg bw caused no compound related mortalities.
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