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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:
21.11.-28.11.2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: 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): Centralit- Substance type: pure substance- Physical state: white crystalline powder- Analytical purity: 99.9% (w/w)- Expiration date of the lot/batch: 16.9.2016- Stability under test conditions: stable- Storage condition of test material: in the dark place at laboratory temperature- pH: approximately 7

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic- Weight at study initiation: 3.0 – 3.1 kg - Housing: individually in cages without bedding - Diet (e.g. ad libitum): pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs - Water (e.g. ad libitum): drinking tap water- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17-23°C- Humidity (%): 30-70%- Air changes (per hr): approximately 15 air changes per hour- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour darkSTUDY TIME SCHEDULEAnimal supply: 16. 11. 2011Experimental part of study: 21.11. – 28. 11. 2011

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 h
Number of animals:
2 males (confirmatory test)
Details on study design:
TEST SITE- Area of exposure: 6x6 cm- Type of wrap if used: gauze patch, foil and cellulose cotton and held in place with non-irritating tape - SpofaplastREMOVAL OF TEST SUBSTANCE- Washing (if done): noSCORING SYSTEM: according to the grading system given in Method B.4 Acute toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The test substance, Centralit, was tested for acute dermal irritation/corrosion.Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at the 1, 24, 48 and 72 hours after exposure. No symptoms of irritation were observed on the skin.No symptoms of systemic toxicity were observed in the animals during the test period. No skin irritation was caused by 4-hour exposure to Centralit.
Executive summary:

The test substance, Centralit, was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test.

Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure.

At first the test substance was applied on the skin of one rabbit (test animal No. 13). Rabbit No. 13 was investigated 3 minutes, 1 hour and 4 hours after application of the test substance.

No evidence of a corrosive effect or symptoms of irritation were observed on the skin after application.

In confirmatory test, two others rabbits (rabbit No. 14 and No. 15) were used with 4-hour exposition period.

No symptoms of irritation on the skin were observed. No other signs of intoxication were observed.

No skin irritation was caused by 4-hour exposure to Centralit.