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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:
from August 21, 2007 to September 10, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
short term temperature deviation
Principles of method if other than guideline:
Increasing of temperature of animals room (up to 26.1°C). The limit (in EU Method B.4) for temperature is 20 ± 3°C. The deviation from the limit was short-term and did not influence the wellness of animals and the study results.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Humic acids, potassium salts
- Molecular formula: not known - UVCB substance
- Molecular weight: not known - UVCB substance
- Substance type: technical product
- Physical state: solid
- Lot/batch No.: 16. 5. 2007/R
- Expiration date of the lot/batch: 05/2022
- Stability under test conditions: stable
- Storage condition of test material: dry conditions

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: breeding farm BioTest s.r.o., Konárovice, 281 25, Czech Republic
- Weight at study initiation: 3.8-4.0 kg
- Housing: individually in cages without bedding in conventional animal room
- Diet (e.g. ad libitum): pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 17 - 23ºC, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: close clipping of the fur on the dorsal area
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (moistened with the smallest amount of water)
Duration of treatment / exposure:
3 min, 1 hour, 4 hours (one animal)
4 hours (2 animals)
Observation period:
1, 24, 48 and 72 hours after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: fur from area 6x6 cm was removed
- Type of wrap if used: gauze patch, foil and cellulose cotton and held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: by water
- Time after start of exposure:
1st patch - 3 minutes
2nd patch - 1 hour
3rd patch - 4 hours

SCORING SYSTEM: Exposed rabbit was examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
Scoring system - see Table 1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No evidence of a irritation/corrosion on the skin
Other effects:
No symptoms systemic toxicity.
No mortality.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No skin irritation was caused by 4-hour exposure.
No other signs of intoxication were observed.
Executive summary:

The test substance 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, Directive 2004/73/EC, published in O.J. L 152, 2004.

Three rabbits were exposed to 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 1, 24, 48 and 72 hours after exposure.

No skin irritation was caused by 4-hour exposure.

No other signs of intoxication were observed.