Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-05-10 (day of application)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
BASF test. In principle the methods described in OECD guideline 402 are used.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Coffein wasserfrei Pulver 200 (Caffeine anhydrous, powder 200)
- Physical state: solid
- Lot/batch No.: 97757
No further data.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K.Thomae GmbH, D-7950 Biberach, Germany
- Weight at study initiation: mean weights: 249 g (males), 229 g (females)
- Housing: individually in stainless steel wire mesh cages
- Diet (ad libitum): Kliba Labordiät 343, Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
olive oil
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped epidermis (dorsal and dorsolateral parts of the trunk), application area: ca. 50 cm²
- Type of wrap if used: four layers adsorbent gauze and porous bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, rinsing with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg bw
- Concentration (if solution): 50% (w/v)

VEHICLE
olive oil (reason: the test substance is insoluble in water)
- Amount(s) applied (volume or weight with unit): 4 ml/kg bw
- Concentration (if solution): 50% suspension
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Signs and symptoms were recorded several times on the day of application, at least once each workday. Check for moribund and dead animals was made twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: (1% significance level)
Mortality:
No deaths occurred.
Clinical signs:
No clinical symptoms and no local findings were observed.
Body weight:
Body weight gain was in the expected range, see freetext below.
Gross pathology:
No pathologic findings were noted.

Any other information on results incl. tables

Table: Body weights in gram

Time of weighing

males

females

Beginning of the test

249

229

After 7 days

279

238

After 14 days

291

248

Applicant's summary and conclusion

Executive summary:

LD50 > 2000 mg/kg bw.

Five male and five female Wistar rats were applied the test substance at a dose level of 2000 mg/kg bw. No deaths, no clinical signs of toxicity, no effect on body weight gain and not pathological findings were observed.