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Registration Dossier
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EC number: 266-013-0 | CAS number: 65996-79-4 The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130°C to 210°C (266°F to 410°F) Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.
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:
- other: GLP compliant, guideline study, available as unpublished report. No restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- occlusive dressing used
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- CAS 68478-10-4
- IUPAC Name:
- CAS 68478-10-4
- Reference substance name:
- E000044146
- IUPAC Name:
- E000044146
- Details on test material:
- - Name of test material (as cited in study report): E000044146
- Colourless liquid; disagreeable odour
- Specific gravity: AP = 0.98 (H2O = 1 at 39.2°F)
- Flash point: AP = 75°F
- Density: 0.9723 g/ml (as determined by UBTL)
- Analytical purity: no data
- Test material data on file with the study sponsor
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Camm Research, Wayne, New Jersey, USA
- Sex: 5 males and 5 females
- Age at study initiation: young adult
- Weight at study initiation: Approximately 2.0 - 3.0 kg
- Housing: Individually, in stainless steel, wire mesh bottom cages
- Diet: Agway rabbit feed ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 61 - 70°F
- Humidity: 40 - 60%
- Air changes: At least 10/h
- Photoperiod: 12 hrs dark/12 hrs light
IN-LIFE DATES: From: 6 March 1990 To: 20 March 1990
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal surface
- Type of wrap if used: occlusive (no further details reported)
- Hair clipped approximately 24 hours before dose application
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg
- Individual volume adjusted based on density of test material and animal's bodyweight - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- 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 weighing: On arrival, the day of dosing, week 1 and at termination
- Clinical observations made hourly for the first 4 hours after dosing, and twice (a.m and p.m.) for the following 13 days
- Necropsy of survivors performed: yes - Statistics:
- Not required
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality and no significant signs of toxicity at only dose tested
- Mortality:
- None
- Clinical signs:
- other: All animals showed one or more of the following observations: oedema, erythema, eschar, dried skin at the test site, abnormal faeces.
- Gross pathology:
- Eight of the ten animals showed one or more of the following observations: oedema, erythema, eschar, dried skin at the test site. The remaining two animals had no gross abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 of E000044146 is greater than 2000 mg/Kg.
- Executive summary:
The acute dermal toxicity of E000044146 (CAS 68487-10-4) was investigated in groups of 5 male and 5 female rats. A single 24 hour application of 2000 mg/Kg in maize oil (20% w/v at 10 mL/Kg) was applied under an occlusive dressing.
There were no mortalities or significant signs of systemic toxicity and it can be concluded that the LD50 of E000044146 (CAS 68487-10-4) is > 2000 mg/Kg and no classification is warranted under GHS/CLP.
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