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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 November 2011 - 02 January 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study generated according to internationally accepted testing guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Graphite, acid-treated
EC Number:
291-367-8
EC Name:
Graphite, acid-treated
Cas Number:
90387-90-9
Molecular formula:
C(Carbon) + acid + oxidant Not available by EC, (CnX mHX)
IUPAC Name:
carbon
Details on test material:
Name: Graphite, acid treated
Common Name: Expandable Graphite
CAS No.: 90387-90-9
Batch no.: 1706

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals were bred for experimental purposes.
Source: Charles River Deutschland, 97633 Sulzfeld, Germany
Age at study initiation: approximately 18 - 19 weeks old
Weight at study initiation: > 2kg

Housing and Feeding Conditions
- Semi barrier in an air-conditioned room
- Temperature: 18 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 0900), rich in crude fibre
- Free access to tap water (drinking water, municipal residue control, microbiological controls at regular intervals)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Adequate acclimatisation period (at least 5 days) under laboratory conditions

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A dose of 0.1 g of the test item was applied to the test site.
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
The animals were observed for 72 hours after dosing.
Number of animals or in vitro replicates:
Number of animals: 3 (female)
Details on study design:
The in vivo test was performed initially using one animal. The untreated contralateral eye served as control. Individual reactions of each animal were recorded at each time of observation. Nature, severity and duration of all lesions observed were described.
For the calculation only the 24, 48 and 72-hour readings were used.

Clinical Observation:
The eyes were examined for signs of irritation throughout the observation period. The eye irritation was scored and recorded according to the grades in the table below.
For the calculation only the 24, 48 and 72-hour readings were used.
At the end of the observation period the treated eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo, Laboratories Alcon, lot no. H 002, expiry date: 08/2012). The eyes were rinsed with physiological saline 0.9% NaCl (B AlleMan Pharma, lot no. 110900, expiry date: 08/2014) after the examination.

Table 1: Grading of Ocular Lesion

Cornea: Degree of Density (Opacity, densest area taken for reading) Score
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4

Iris Score
Normal 0
Markedly deepened ruga, congestion, swelling, moderate circumcorneal hyperaemia, or injection; iris reactive
to light (a sluggish reaction is considered to be an effect) 1
Haemorrhage, gross destruction, or no reaction to light 2

Conjunctiva: Redness (refers to palpebral and bulbar conjunctiva: excluding cornea and iris) Score
Normal 0
Some blood vessels hyperaemic (injected) 1
Diffuse crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3

Conjunctiva: Chemosis, Swelling (refers to lids and/or nictitating membranes) Score
Normal 0
Some swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Conjunctival Redness
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
other: Conjunctival Redness
Basis:
animal #1
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Remarks on result:
other: Average Score: 0
Irritation parameter:
other: Conjunctival Redness
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
other: Conjunctival Redness
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Remarks on result:
other: Average Score: 0
Irritation parameter:
other: Conjunctival Redness
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
other: Conjunctival Redness
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: Average Score: 0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Average Score: 0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Average Score: 0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Average Score: 0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Average Score: 0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Average Score: 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: Average Score: 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Average Score: 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Average Score: 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Average Score: 0
Irritant / corrosive response data:
The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the eye.

Any other information on results incl. tables

Table 2: Clinical Signs of Toxicity

Animal No. 1, No. 2 and No. 3

Time after Test Item Application

Systemic Findings

Local Findings

1 hour

nsf

nsf

24 hours

nsf

nsf

48 hours

nsf

nsf

72 hours

nsf

nsf

 

Table 3: Absolute Body Weights in kg

 

Animal No. 1

Animal No. 2

Animal No. 3

Start of Study (weight in kg)

4.6

3.9

3.8

End of Study (weight in kg)

4.6

4.0

3.8

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study, a single ocular application of the test item Graphite, acid treated to rabbits at a dose of 0.1 g produced minor initial irritant, but no corrosive effects. Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC, the test item Graphite, acid treated has no obligatory labelling requirement for eye irritation.
According to Annex I of Regulation (EC) 1272/2008, the test item Graphite, acid treated has no obligatory labelling requirement for eye irritation.
According to GHS (Globally Harmonized Classification System) [8] the test item Graphite, acid treated has no obligatory labelling requirement for eye irritation.
Executive summary:

Three female New Zealand White Rabbits (Crl: KBL (NZW)) were treated with the test item by a single ocular application at a dosage of 0.1 g. After the application into the eyes of three female NZW rabbits the test item produced neither irritant nor corrosive ocular effects. Neither mortalities nor significant clinical signs of toxicity were observed. Upon fluorescein examinations at the end of the observation period of 72 hours no corneal lesions were found in any animal.

The calculated mean scores (Table 4) did not exceed the limit values according to Directive 2001/59/EC, to Regulation (EC) 1272/2008 and to GHS.

Table 4: Mean Values of Eye Irritation Scores – (24, 48, 72 Hour Reading)

Animal No.

 

Sex

Conjunctival Redness

Conjunctival Chemosis

Iris

Cornea Opacity

1

female

0.00

0.00

0.00

0.00

2

female

0.00

0.00

0.00

0.00

3

female

0.00

0.00

0.00

0.00

 

In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC, the test item Graphite, acid treated has no obligatory labelling requirement for eye irritation.

According to Annex I of Regulation (EC) 1272/2008, the test item Graphite, acid treated has no obligatory labelling requirement for eye irritation.

According to GHS (Globally Harmonized Classification System) the test item Graphite, acid treated has no obligatory labelling requirement for eye irritation.