Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The reliability is rated Klimish 1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Milled clinker of Ciment Fondu®
IUPAC Name:
Milled clinker of Ciment Fondu®
Details on test material:
- Name of test material (as cited in study report): Milled Clinker of Ciment Fondu®
- Molecular weight (if other than submission substance): not applicable
- Substance type: mineral
- Physical state: dark grey fine powder
- Composition of test material, percentage of components: Main mineralogical phase CA. Other mineralogical phase above 10% : ferrite, spinel
- Analytical purity: 100%
- Lot/batch No.: 70398
- Expiration date of the lot/batch: awaited
- Storage condition of test material: at room temperature in accordance with the Sponsor's instructions

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: Grimaud Freres Selection - La Corbière - F-49450 Roussay
- Weight at study initiation: between 1.9 kg and 2.3 kg at the start of the experiment
- Housing: Animals were housed individually in cages of standard size
- Diet : SDS/DIETEX STANRAB (P) SQC ad libitum
- Water : ad libitum
- Acclimation period: For at least 5 days before the treatment, in the area where the experiment took place.
-Sex: female

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-21
- Humidity (%): 45-65
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness with light on at 7.30 a.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of the rabbits served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1g of Milled clinker of ciment fondu



Duration of treatment / exposure:
Single dose.
Following treatment, animals were kept for approximately one hour in a restraint cage, or was fitted with a collar, in order to prevent rubbing of
the eye.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: n.a


SCORING SYSTEM: according to OECD 405


TOOL USED TO ASSESS SCORE: direct examination

About 72 hours before testing, the presence or absence of corneal damage was carried out by examination after instillation of a 0.5% aqueous
solution of sodium fluorescein and rinsing with sterile and pyrogen free isotonic saline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal: all
Time point:
other: 1 hour
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: all
Time point:
other: 24 hours
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
other: Lacrimation
Basis:
animal: all
Time point:
other: 1 hour
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal: all
Time point:
other: 1 hour
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal: all
Time point:
other: 24 hours
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal: all
Time point:
other: 48 hours
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal: all
Time point:
other: 0 - 72 hours
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: all
Time point:
other: 0 - 72 hours
Max. score:
0
Irritant / corrosive response data:
One hour after instillation, all animals presented a severe chemosis (score 4) with lacrimation (score 2) and a severe redness of the conjunctivae
(score 3).
24 hours after instillation, all animals had a slight chemosis (score 1) and a moderate redness of the conjunctivae (score 2).
48 hours after instillation, a slight redness of the conjunctivae (score 1) persisted in all animals.
No other ocular lesion was observed in any animal until the end of the exposure period (i.e. time 72 hours).
Mean indices were calculated from results obtained for each rabbit at times 24, 48 and 72 hours
Other effects:
The application of the test item did not induce colouring of the application site and did not interfere with grading of any eye lesion.

Any other information on results incl. tables

Results of mean Index (MI)

 Treatment  Animal Number  Chemosis  Redness  Iris  Cornea
 Milled Clinker of Ciment Fondu® 20091043/20091044/20091045  0.33/0.33/0.33  1/1/1  0/0/0  0/0/0 

For each parameter, mean of indices for each rabbit for the three times was noted (Mean index per parameter, per animal for the three times = Mi). The maximum theoretical score is 4 (chemosis), 3 (redness), 2 (iris lesions) and 4 (corneal lesions).

Individual Weight:

 Treatment  animal number  day 1  72 hours

Milled Clinker of Ciment Fondu®

20091043

20091044

20091045

 
1.992 /1.897 / 2.265 2.082/ 2.049/ 2.357 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions adopted, Milled Clinker of Ciment Fondu® (Batch No. 70398) was found to be non-irritant for the skin of the rabbit
Classification according to Directive No. 67/548/EEC and subsequent amendments and CLP Regulation No. 1272/2008:
Symbol: none is required.
Indication of danger: none is appropriate.
Risk phrase: none is applicable
Executive summary:

Irritation and corrosion of the test item Milled Clinker of Ciment Fondu® was evaluated following a single ocular instillation in the rabbit according to OECD Guideline No. 405.

Three animals were used for the study. 0.1 g of Milled Clinker of Ciment Fondu® was introduced into the conjunctival sac of the left eye of each of the animals. The untreated right eye served as a control.

The application of the test item did not induce colouring of the application site and did not interfere with grading of any eye lesion. Any conjunctival, iris and corneal lesion was evaluated approximately one hour, 24 hours, 48 hours and 72 hours after instillation of Milled Clinker of Ciment Fondu®.

Mean indices were calculated from results obtained for each rabbit at times 24, 48 and 72 hours

Results obtained were as follows for the 3 animals (numbers 20091043, 20091044 & 20091045) :

chemosis : 0.33

redness : 1

iris : 0

cornea : 0

One hour after instillation, all animals presented a severe chemosis (score 4) with lacrimation (score 2) and a severe redness of the conjunctivae (score 3).

24 hours after instillation, all animals had a slight chemosis (score 1) and a moderate redness of the conjunctivae (score 2).

48 hours after instillation, a slight redness of the conjunctivae (score 1) persisted in all animals.

No other ocular lesion was observed in any animal until the end of the exposure period (i.e. time 72 hours).

Milled Clinker of Ciment Fondu® (Batch No. 70398) was found to be non-irritant for the eye of the rabbit.

Categories Display