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Administrative data

Description of key information

Based on read-across following an analogue approach:
Skin: OECD 404; GLP; rabbit; unchanged test substance; not irritating to skin
Eye: OECD 405; GLP; rabbit; unchanged test substance; not irritating to eyes

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
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
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.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
72 h
Score:
0
Max. score:
4
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
14 Jan 2008 - 21 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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeding farm BioTest, s r.o., Konárovice, 281 25 Czech Republic, RČH CZ 21760152
- Age at study initiation: 4-5 months
- Weight at study initiation: 3.0-3.5 kg
- Housing: individually in metallic cages
- Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs (made by Bergman, Mill Kocanda, Jesenice u Prahy) ad libitum
- Water (e.g. ad libitum): drinking tap water ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 14 Jan 2008 To: 21 Jan 2008
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 24, 48 , 72 h
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with water.
- Time after start of exposure: 24 h


SCORING SYSTEM: Draize scores


TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Clinical examination of eye

Rabbit No. 1:
1 hour: Conjunctivae - some blood vessels hyperaemic (injected)
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations

Rabbit No. 2:
1 hour: Conjunctivae - some blood vessels hyperaemic (injected), Chemosis - some swelling above normal
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations

Rabbit No. 3
1 hour: Conjunctivae - some blood vessels hyperaemic (injected)
24 hours: No alterations
48 hours: No alterations
72 hours: No alterations
Other effects:
No signs of systemic intoxication were observed.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
The following changes were observed in the treated eyes at 1 h post-application: some blood vessels were hyperaemic (injected) in all animals, and in one animal, some swelling above normal was noted. At 24, 48 and 72 h after application no signs of eye irritation were observed. No clinical signs of systemic intoxication were detected. It was concluded that the test substance is not irritating to the eye of rabbits.
The test substance does not fufil the requirements to be classified according to DSD and CLP criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no substance specific data available on the skin and eye irritation potential of ashes (residues), cenospheres.

Ashes (residues), cenospheres and ashes (residues), coal share a common production process as substances derived from coal combustion. Ashes (residues), cenospheres represent a fraction of ashes (residues), coal separated by physical means. Both substances exhibit similarities in physicochemical properties and chemical composition. The main differences consist in a much lower content of water soluble matter and the particle size distribution of ashes (residues), cenospheres.

In terms of hazard assessment, studies available for ashes (residues), coal are therefore taken into account by read-across following an analogue approach, the results of these studies being considered a worst case for ashes (residues), cenospheres.

Skin irritation

Ashes (residues) were tested for acute dermal irritation/corrosion according to OECD guideline 404 and complying with GLP. Three albino rabbits were exposed to 0.5 g of test substance, applied onto the 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. The test substance was applied first on the skin of one rabbit, in which very slight erythema was observed upon removal of the patch after the 4-hour exposure. In a confirmatory test, two more rabbits were used. No evidence of irritation/corrosion effects was observed on the skin and no other signs of intoxication were seen. The mean erythema and edema scores over 24, 48 and 72 h were both 0 for all three animals (Rösslerová, 2008).

 

Eye irritation

Ashes (residues) were tested for eye irritation/corrosion in albino rabbits in a study performed according to the OECD guideline 405 and complying with GLP. The test material (0.1 g) was applied into the conjunctival sac of one eye and removed after 24 h by rinsing with water; the other eye served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Initially, one animal was tested only, in which no corrosive effects were observed. The negative response was confirmed using two additional animals. Conjunctivae and chemosis effects were observed in all animals at 1 h post-application: some blood vessels were hyperaemic (injected) and in one animal some swelling above normal was noted. No signs of eye irritation were observed at the subsequent readings. The average cornea, iris, conjunctivae and chemosis scores over 24, 48, and 72 h were all 0 for all animals (Rösslerová, 2008).

Justification for classification or non-classification

Based on read-across following an analogue approach, the available data on the skin and eye irritation potential of ashes (residues), cenospheres is conclusive but not sufficient for classification according to GHS (CLP, 1272/2008/EC) criteria for classification and labelling.