Ashes (residues), cenospheres

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

07 Jan 2008 - 14 Jan 2008

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ashes (residues), coal

EC Number:

931-322-8

Molecular formula:

Not applicable (UVCB substance)

IUPAC Name:

Ashes (residues), coal

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding farm BioTest s.r.o., Konárovice, 281 25, Czech Republic
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.8-3.2 kg
- Housing: individually in cages without bedding in a conventional animal room
- Diet (e.g. ad libitum): pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum, made by Bergman, Kocanda Mill, 252 42 Jesenice u Prahy
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%):30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 07 Jan 2008 To: 14 Jan 2008

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:0.5 g

Duration of treatment / exposure:

Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h

Observation period:

Following initial and confirmatory tests: 1, 24 , 48, 72 h

Number of animals:

3 animals (1 female and 2 males)

Details on study design:

TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 10
- Type of wrap if used: The test substance was covered by gauze patch, foil and cellulose cotton and held in place with non-irritating tape (Spofaplast)


REMOVAL OF TEST SUBSTANCE
- Washing: At the end of each exposure period the patch was removed and remaining sample was washed off with water.
- Time after start of exposure: 3 min, 1 and 4 h


SCORING SYSTEM: Draize scores

INITIAL TEST:
- Test substance was applied to one animal (rabbit No. 1). Skin reaction was evaluated after 3 min, 1 and 4 h. At 4 h exposure, very slight erythema was observed. After 4-hour exposure, rabbit No. 1 was evaluated for skin reactions according to standard time schedule (24, 48 and 72 h).

CONFIRMATORY TEST:
- Because in the initial test no skin irritation was observed, two additional animals (rabbits No. 2 and 3) were used to confirm the negative response. One patch was applied to each of 2 animals for an exposure period of 4 hours. Skin reactions were evaluated after patch removal at 1, 24, 48 and 72 h post-application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 1 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 1 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

24 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

48 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

48 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 3 animals

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

In the initial test with one animal, very slight erythema and no edema were observed immediately after a 4 h exposure. No irritant reponses were observed in any animal at any other reading time point.

Other effects:

No symptoms of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

The test substance was tested for acute dermal irritation/corrosion. Three rabbits were exposed to 0.5 g of the test substance, applied onto the clipped skin for 4 h 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. No symptoms of systemic toxicity were observed in the animals during the test period. No skin irritation was caused by a 4-hour exposure to the test substance.
The test substance does not fufil the requirements to be classified according to DSD and CLP criteria.