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Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 3-17,2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP, test performed before withdrawal of the guideline in 2002
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: liquid
- Details on test material:
- - Identity: Alkylnaphthalene sulfonic acid
- Physical state: Dark brown viscous liquid
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA
- Age at study initiation: 11-12 weeks
- Weight at study initiation: Males: 236-290 g; Females: 201-233 g
- Fasting period before study: yes 24.5 h before and 3 h after dosing
- Housing: individually
- Diet: Purina Rodent Chow #5012 ad libitum
- Water: Filtered tap water ad libitum:
- Acclimation period: 27 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE: none
MAXIMUM DOSE VOLUME APPLIED: 0.62 mL (< 1 ml/100g) - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-BW on day 0, 7 and 14
-Clinical signs on day 1 (1 and 3 hours after dosing) and daily thereafter (included gross evaluation of skin and fur, eyes and mucous membranes,
respiratory, circulatory, autonomic and central nervous systems, motor activity and behavior pattern)
- Necropsy of survivors performed: yes, gross examination on day 14 - Statistics:
- NA
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- none observed
- Body weight:
- within normal ranges
- Gross pathology:
- no findings
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test substance in rats is > 2000 mg/kg bw
- Executive summary:
The test substance was administered by gavage to 5 rats/sex at 2000 mg/kg bw. No mortality, no clinical signs, no effects on body weight and no macroscopic findings were seen. The LD50 is > 2000 mg/kg bw.
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