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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-9-16 to 1997-9-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Creatine Monohydrate
- Substance type: organic
- Physical state: solid; white crystals
- Analytical purity: 101.8%
- Purity test date: 1997-7-29
- Lot/batch No.: CRT 197
- Expiration date of the lot/batch: 1998-6-19
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: > 6 weeks
- Weight at study initiation: < 3.5 kg
- Housing: individually
- Diet (e.g. ad libitum): standard laboratory rabbit diet
- Water (e.g. ad libitum): free access to tap-water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance; moistened with water
Duration of treatment / exposure:
4 h
Observation period:
skin reactions were assessed at approximately 1, 24, 48 and 72 hours after removal of the dressings and test substance
Number of animals:
3 of either sex
Details on study design:
TEST SITE
- Area of exposure: 2x3 cm²
- Type of wrap if used: micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of dressing and of remaining test substance using a tissue moistened with tap-water and subsequently a dry tissue
- Time after start of exposure: 4 hours

SCORING SYSTEM: numerical scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
1297
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
1298
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
1300
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
1297
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
1298
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
1300
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No skin irritation was caused by 4 hours exposure to creatine monohydrate. There was no evidence of a corrosive effect on the skin.
Other effects:
No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

No edema and erythema after 4 hours of exposure; scoring of erythema and edema: for all three animals after 1, 24, 48 and 72 hours score 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Creatine Monohydrate does not have to be classified and has no obligatory labelling requirement for skin irritation.
Creatine Monohydrate is not irritating.
Executive summary:

A primary dermal irritation study with creatine monohydrate in the rabbit (4-hour semi-occlusive application) was conducted based on the OECD guideline No. 404, "Acute Dermal Irritation/Corrosion".

Three male rabbits (at least 6 weeks old; weight: 1893-2069 g) were exposed to 0.5 grams of creatine monohydrate moistened with water (equivalent to 0.44 g creatine) to 2x3 cm clipped skin in the dorsal area for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. Irritation was graded according a numerical scoring system. No skin irritation was caused by 4 hours exposure to creatine monohydrate. In this study creatine monohydrate is not irritating to the skin and does not have to be classified.