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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:
8.3.2010 - 15.3.2010
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:
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: Ashes (residues) – Biomass Combustion
- Physical state: solid
- Substance type: technical product
- Appearance: black powder

- Composition of test material, percentage of components:
SiO2 37.81 % (w/w), K2O 17.01 % (w/w), CaO (total) 11.92 % (w/w), P2O5 6.15 % (w/w), Al2O3 4.05 % (w/w), SO3 (sulphate) 3.47 % (w/w), MgO 2.25 % (w/w), Fe2O3 1.81 % (w/w), CaO (free) 1.40 % (w/w), CO2 1.29 % (w/w), Na2O 0.60 % (w/w), TiO2 0.34 % (w/w).
- Impurities (identity and concentrations):
Metals: As, Be, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Se, Tl, V, Zn sum <
0.1%

- Lot/batch No.: BMA/F/2009
- Expiration date of the lot/batch: 15 years / 12/2024
- Storage condition of test material: PE container, temperature bellow 40°C

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
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 3.2-3.6 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 (producer: Ing.Mrkvička Miroslav - Výroba krmných směsí, Mlýn Kocanda, 252 42 Jesenice u Prahy))
- Water (e.g. ad libitum): 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 (°C): 17 - 23°C, permanently monitored
- Humidity (%): 30 – 70 %, permanently monitored
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

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 hours
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3 rabbits
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

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours

SCORING SYSTEM: see Table 1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 7
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 7
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: 8
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 8
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal: 9
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 9
Time point:
other: 24,48,72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no evidence of a corrosive effect on the skin.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
No histopathology was performed.

Any other information on results incl. tables

Table 2: Skin reactions in experimental animals – grades

Time after

 4-hours exposure

Observation

Rabbit No. 7

Rabbit No. 8

Rabbit No. 9

1 hour

Erythema      1

 Oedema       0

Erythema      1

 Oedema       0

Erythema      1

 Oedema       0

24 hours

Erythema      0

 Oedema       0

Erythema      0

 Oedema       0

Erythema      0

 Oedema       0

48 hours

 Erythema     0

 Oedema       0

Erythema      0

 Oedema       0

Erythema      0

 Oedema       0

72 hours

Erythema      0

 Oedema       0

Erythema      0

 Oedema       0

Erythema      0

 Oedema       0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance, Ashes (residues) – Biomass Combustion, 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. Very slight skin irritation was observed in all animals at the 1 hour after application. At 24, 48 and 72 hours after application no irritation of the skin was observed in all animals.
No symptoms of systemic toxicity were observed in the animals during the test period.
No skin irritation was caused by 4-hour exposure to Ashes (residues) – Biomass Combustion.
Executive summary:

The test substance, Ashes (residues) – Biomass Combustion, 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. 7). Rabbit No. 7 was investigated 3 minutes, 1 hour and 4 hours after application of the test substance. Very slight erythema was observed on the skin after 1hour and 4 hours.

In confirmatory test, two others rabbits (rabbit No. 8 and No. 9) were used with 4-hour exposition period. Very slight erythema was observed at the 1 hour after 4-hour exposure to the test substance in all animals. At the 24, 48 and 72 hours after exposure no irritation of the skin was observed in all animals.

No skin irritation was caused by 4-hour exposure to Ashes (residues) – Biomass Combustion. No other signs of intoxication were observed.