Caffeine

Acute Toxicity: dermal

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

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

Test material information

Constituent 1

Reference substance name:

Caffeine

EC Number:

200-362-1

EC Name:

Caffeine

Cas Number:

58-08-2

Molecular formula:

C8H10N4O2

IUPAC Name:

1,3,7-trimethyl-3,7-dihydro-1H-purine-2,6-dione

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 or test system 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:

other: No clinical symptoms and no local findings were observed.

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.