Registration Dossier
Registration Dossier
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EC number: 206-462-1 | CAS number: 345-78-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP, near guideline study, available as unpublished report. Minor restrictions in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- According to BASF-internal standard: Five Wistar rats per sex per dose were exposed by single application to the clipped epidermis for 24 hours followed by a 14 day observation period.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Pseudoephedrine hydrochloride
- EC Number:
- 206-462-1
- EC Name:
- Pseudoephedrine hydrochloride
- Cas Number:
- 345-78-8
- Molecular formula:
- C10H15NO.ClH
- IUPAC Name:
- 2-(methylamino)-1-phenylpropan-1-ol hydrochloride
- Details on test material:
- - Name of the test substance used in the study report: (+)-Pseudoephedrin-HCL
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, D-7950 Biberach, FRG
- Weight at study initiation: Males: 282 g; Females: 229 g
- Housing: single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxal, FRG)
- Diet: Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod: (12 hrs dark / 12 hrs light)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
Single application to the clipped epidermis (Dorsal and dorsolateral parts of the trunk)
- Area of exposure: about 50 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application site with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2000 mg/kg bw (4 mL)
- Concentration: 50% (w/v)
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- 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: Recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
- Scoring of skin findings: 30-60 minutes after removal of the semiocclusive dressing and then about one week later and before termination of the study.
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 abnormalities
- Gross pathology:
- No abnormalities
- Other findings:
- Local findings: distinct erythema and slight edema (day 1). Incrustation was observed from day 1 to day 7.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the performed acute toxicity test the LD50 for dermal exposure was determined to be >2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study (similar to OECD TG 402) 5 male and 5 female Wistar rats were treated with 2000 mg/kg bw test substance for 24 h under semiocclusive conditions. After the exposure period, skin was rinsed with warm water. No mortality occurred and no clinical or pathological abnormalities were observed. Distinct erythema and slight edema on day 1 and incrustation from day 1 to day 7 was observed. The LD50 was determined to be >2000 mg/kg bw.
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