Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31.5. - 9.6.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
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): Reaction product of Distillates (petroleum), acid-treated heavy naphthenic and calcium oxide - Molecular formula: not known - UVCB substance
- Molecular weight: not known - UVCB substance
- Smiles notation: not known - UVCB substance
- InChl: not known - UVCB substance
- Substance type: technical product
- Physical state: solid
- Lot/batch No.: 26.2.2010
- Expiration date of the lot/batch: 26.2.2012
- Stability under test conditions: stable
- Storage condition of test material: The substance was stored in PE bottle at room temperature.

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, RČH CZ 21760152
- Weight at study initiation: 3.3-3.9 kg
- Housing: individually in cages without bedding in conventional animal room
- Diet: pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum (producer: Ing.Mrkvička Miroslav - Výroba krmných směsí, Mlýn Kocanda, 252 42 Jesenice u Prahy, Czech Republic))
- Water: drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: room temperature 17 - 23ºC, permanently monitored
- Relative humidity: 30 - 70 %, permanently monitored
- Photoperiod: 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 applied: 0.5 g

Duration of treatment / exposure:
Duration of exposure:
one animal: 3 min, 1 hour, 4 hours (three patches were applied sequentially to one animal)
two animals: 4 hours



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: gauze patch, foil and cellulose cotton and held in place with non-irritating tape Spofaplast

REMOVAL OF TEST SUBSTANCE
- Washing: by water

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 bellow.

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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.

The test was performed according to the 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. The skin of this rabbit was investigated 3 minutes, 1 hour and 4 hours after application of the test substance. No symptoms of irritation were observed on the skin.

In confirmatory test, two others rabbits were used with 4-hour exposition period. No evidence of a corrosive effect or symptoms of irritation were observed on the skin.

No other signs of intoxication were observed.