Registration Dossier

Diss Factsheets

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: Comparable to guideline study (no GLP).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Pseudoephedrine hydrochloride
EC Number:
206-462-1
EC Name:
Pseudoephedrine hydrochloride
Cas Number:
345-78-8
IUPAC Name:
2-(methylamino)-1-phenylpropan-1-ol hydrochloride
Details on test material:
Name: (+)-Pseudoephedrine hydrochloride
Purity: 99-100.5%
Appearance: white chrystals
Batch No.: 23359

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, Germany
- Weight at study initiation: 200-300 g
- Housing: single housing in stainless steel wire mesh cages
- Diet: Kliba-Labordiaet 343, Fa. 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: 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 (application volume 4 mL/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 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: clinical signs, 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.
Pathology: Withdrawal of food about 16 hours before sacrifice with CO2, then necropsy with gross-pathological examination. Necropsy of all animals that die as early as possible.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality occurred
Clinical signs:
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