Coffee, bean, roasted, ext.

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

SIDS Initial Assessment Report for SIAM 14: Caffeine (CAS 58-08-2)

Author:

OECD

Year:

2002

Bibliographic source:

OECD SIDS

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

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

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: caffeine (anhydrous powder), purity of 98.5 - 100 % w/w
- Expiration date of the lot/batch: not available
- Purity test date: not available

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not available
- Stability under test conditions: not available
- Solubility and stability of the test substance in the solvent/vehicle: not available
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not available

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not available
- Preliminary purification step (if any): not available
- Final dilution of a dissolved solid, stock liquid or gel: not available
- Final preparation of a solid: not available

OTHER SPECIFICS: none

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

A 24-hour semiocclusive application of a 50% (w/v) aqueous suspension of the test substance. After 24 hours, the patches were removed, and the application sites were washed with water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observation period of 14 days post exposure.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths were recorded.

Clinical signs:

other: No signs of toxicity were observed within the 14-day observation period.

Gross pathology:

No local/pathological findings were observed within the 14-day observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value in this study has been determined at >2000 mg/kg body weight, indicating that the aqueous caffeine solution has low acute toxicity and it does not meet the classification criteria for skin irritation under the CLP Regulation (EC) No 1272/2008

Executive summary:

The acute dermal toxicity study in male and female Wistar rats was performed to assess the acute toxicity potential of caffeine solution.

A 24-hour semiocclusive application of a 50% (w/v) aqueous suspension of caffeine at 2000 mg/kg body weight was applied on five male and five female Wistar rats. After 24 hours, the patches were removed, and the application sites were washed with water. No deaths, signs of toxicity, or local/pathological findings were observed within the 14-day observation period.

The LD50 value in this study has been determined at >2000 mg/kg body weight, indicating that the aqueous caffeine solution has relatively low acute toxicity and does not meet GHS criteria for acute toxicity classification.