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EC number: 292-697-5 | CAS number: 90989-41-6
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- other: GLP compliant, guideline study, available as unpublished report, minor restrictions in reporting but otherwise adequate for assessment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 (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Naphtha (petroleum), steam-cracked middle arom.
- EC Number:
- 271-138-9
- EC Name:
- Naphtha (petroleum), steam-cracked middle arom.
- Cas Number:
- 68516-20-1
- IUPAC Name:
- Naphtha (petroleum), steam-cracked middle arom.
- Reference substance name:
- E000144700
- IUPAC Name:
- E000144700
- Details on test material:
- - Name of test material (as cited in study report): E000144700
- Physical state: Clear, pale yellow to yellow liquid, gasoline-like naphtha odour
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Stability under test conditions: Stable
- Storage condition of test material: 50-80°F
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 food ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 61-70°F
- Humidity: 40-60%
- Air changes: At least 10/hour
- 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 (size of application area not reported)
- Type of wrap if used: Occlusive (no further details reported)
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes (Individual dose volumes were adjusted based on the density (0.9145 g/mL) and the 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 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
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no mortality or evidence of systemic toxicity at only dose tested
- Mortality:
- No mortalities.
- Clinical signs:
- All animals on study exhibited one or more of following: oedema, erythema, eschar and dried skin at test site, abnormal stools.
- Body weight:
- All animals gained weight during the study.
- Gross pathology:
- All animals exhibited one or more of following: oedema, erythema, eschar and dried skin at test site.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 for E000144700 is greater than 2000 mg/kg.
- Executive summary:
The acute dermal toxicity of E000144700 (CAS 68516-20-1) was assessed in a group of 5 male and 5 female albino rabbits. The test substance was applied at 2000 mg/kg under an occlusive dressing for 24 hours. None of the animals died and there were no significant signs of systemic toxicity.
The acute dermal LD50 for E000144700 (CAS 68516-20-1) is greater than 2000 mg/kg and no classification is warranted under GHS/CLP.
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