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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22. 03. – 01. 04. 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.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ashes (residues) – Biomass Combustion
- Substance type: technical product
- Physical state: solid
- Impurities (identity and concentrations):
Metals: As, Be, Cd, Co, Cr, Cu, Hg, Mo, Ni, Pb, Sb, Se, Tl, V, Zn sum <
0.1%
- Composition of test material, percentage of components:
SiO2 37.81 % (w/w), Al2O3 4.05 % (w/w), Fe2O3 1.81 % (w/w), TiO2 0.34 %
(w/w), CaO total 11.92 % (w/w), MgO 2.25 % (w/w), Na2O 0.60 % (w/w),
K2O 17.01 % (w/w), P2O5 6.15 % (w/w), SO3 (sulphate) 3.47 % (w/w), CO2
1.29 % (w/w), CaO free 1.40 % (w/w)

- Lot/batch No.: BMA/F/2009

- Storage condition of test material: PE container, temperature bellow 40°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic
- Age at study initiation: 4-5 months
- Weight at study initiation: 3.1-3.7 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

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after application, then 1x daily
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was irrigated with water.
- Time after start of exposure: at 24 hours after application

SCORING SYSTEM: ...

TOOL USED TO ASSESS SCORE: fluorescein and the ophthalmoscopy

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 12
Time point:
other: 24, 48, 72 h
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritation parameter:
cornea opacity score
Basis:
animal: 15
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5
Irritation parameter:
cornea opacity score
Basis:
animal: 16
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 12
Time point:
other: 24, 48, 72 hrs
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
conjunctivae score
Basis:
animal: 15
Time point:
other: 24, 48, 72 h
Score:
1 - 2
Max. score:
3
Reversibility:
fully reversible within: 6
Irritation parameter:
conjunctivae score
Basis:
animal: 16
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3
Irritation parameter:
chemosis score
Basis:
animal: 12
Time point:
other: 24, 48, 72 h
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 1 day
Irritation parameter:
chemosis score
Basis:
animal: 15
Time point:
other: 24, 48, 72 h
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 1 day
Irritation parameter:
chemosis score
Basis:
animal: 16
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
see Table 1

Any other information on results incl. tables

Table 1 Results of acute eye reaction (grades)

Animal

Ocular lesions

Time interval of examination

No.

1 h

24 h

48 h

72 h

12

Cornea

0

1

0

0

Iris

0

0

0

0

Conjunctivae

2

3

1

1

Chemosis

1

1

0

0

15

Cornea

1

1

1

1

Iris

0

0

0

0

Conjunctivae

2

2

1

1

Chemosis

3

1

0

0

16

Cornea

0

0

0

0

Iris

0

0

0

0

Conjunctivae

2

1

1

1

Chemosis

1

0

0

0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The following changes were observed on eye at 1 hour after application: conjunctivae – diffuse, crimson colour, individual vessels not easily discernible; chemosis – some swelling above normal or sweling with lids about half closed in all rabbits.
In two different rabbits lacrimation or cornea – scattered or diffuse areas of opacity; details of iris clearly visible was observed at 1 hour after application. Chemosis – some swelling above normal; cornea - scattered or diffuse areas of opacity; details of iris clearly visible were observed in two animals and conjunctivae (various grade) were observed in all animals at the 24 hours after application.
Different changes in the eyes persisted through 48-hour and 72-hour observation interval in all animals.
In two rabbits no alteration appeared at the 4 day after application. In one rabbit the ocular reactions on the cornea and conjunctivae were observed also at this time interval. Changes on the cornea persisted to the 6th day after application. On the 7th day no alterations appeared.
No clinical signs of systemic intoxication were detected.
Examination of eye irritation after single application demonstrated, that the test substance, Ashes (residues) - Biomass Combustion, was slightly irritating for the eye of rabbit, but all signs of irritation disappeared till 7th day after exposure.
Executive summary:

The test substance, Ashes (residues) – Biomass Combustion, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).

The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test was performed initially using one animal (No. 12). Because a corrosive effect was not observed in initial test, the response was confirmed using two additional animals
(No. 15 and No. 16).

The following changes were observed on eye at 1 hour after application:conjunctivae –diffuse, crimson colour, individual vessels not easily discernible; chemosis – some swelling above normal or sweling with lids about half closed in all rabbits. In one rabbit (No. 12) lacrimation and rabbit (No. 15) cornea – scattered or diffuse areas of opacity; details of iris clearly visible was observedat 1 hour after application. Chemosis – some swelling above normal;cornea - scattered or diffuse areas of opacity; details of iris clearly visiblewere observed in two animals and conjunctivae (various grade) were observed in all animals at the 24 hours after application. Different changes in the eyes persisted through 48-hour and 72-hour observation interval in all animals. In two rabbits no alteration appeared at the 4 day after application. In one rabbit the ocular reactions on the cornea and conjunctivae were observed also at this time interval. Changes on the cornea persisted to the 6thday after application. On the 7thday no alterations appeared. 

No clinical signs of systemic intoxication were detected.

Examination of eye irritation after single application demonstrated, thatthe test substance,Ashes (residues) – Biomass Combustion,was slightly irritating for the eye of rabbit, but all signs of irritation disappeared till 7thday after exposure.