Registration Dossier

Administrative data

Endpoint:
skin 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 404 (Acute Dermal 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®
- 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Grimaud Freres Selection - La Corbière - F-49450 Roussay
- Weight at study initiation: between 2.2 kg and 2.4 kg at the start of the experiment
- Housing: Animals were housed individually in cages of standard size
- Diet : SDS/DIETEX STANRAB (P) SQC feed ad libitum
- Water (e.g. ad libitum): 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

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent surfaces of non-treated skin of each animal served as a control for the trial
Amount / concentration applied:
0.5g of Milled Clinker of Ciment Fondu
Duration of treatment / exposure:
Exposure of one animal: Milled Clinker of Ciment Fondu® was applied three times sucessively for a duration of three minutes, one hour and four hours respectively.
Exposure of two additional animals: Milled Clinker of Ciment Fondu® was applied once only, for a duration of exposure of 4 hours.
Observation period:
Exposure of one animal: 3 min, One hour, 24 hours, 48 hours and 72 hours approximately after removal of the dressing
Exposure of two additional animals: One hour, 24 hours, 48 hours and 72 hours approximately after removal of the dressing
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: the treatment region of each rabbit was carefully clipped free of fur over an area of at least 14 cm x 5 cm. The test item was
placed on a gauze square of approximately 6 cm2.
- Type of wrap if used: gauze moistened with 0.5 ml of sterile water. This gauze square
was protected by a pad consisting of a semi-occlusive micro-porous and non-allergenic dressing and
held in place with a supple and aerated fastening system consisting of elastic, adhesive, hypoallergenic
tape.


REMOVAL OF TEST SUBSTANCE
- Washing: yes, with sterile water
- Time after start of exposure: 3 minutes, one hour, four hours : so at the end of the exposure period


SCORING SYSTEM: Grading of Skin Reactions displayed in the OECD 404 method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Irritation parameter:
edema score
Basis:
animal: all
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Irritant / corrosive response data:
No cutaneous lesion was observed in any animal
Other effects:
At the end of the exposure period, a black colour appear. Residual test item was removed with a rinsing procedure and did not affect the cotation

Any other information on results incl. tables

Results of mean index (MI) :

Treatment : Milled Clinker of Ciment Fondu®

Animal number : 20090983 - 20090984 - 20090985

Erythema : 0 - 0 - 0

Oedema : 0 - 0 - 0

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

Acute skin lesions - Individual scores - Milled Clinker of Ciment Fondu® :

Animal serial number 1 - 2 -3 - 4 - 5

Time : 1h - 24h - 48h - 72h

All scores equal to 0 for eryhtema ans eschar; and for oedema

1:20090983 - 3min exposure 2:20090983 - 1h exposure 3:20090983 - 4h exposure 4:20090984 5:20090985

Individual weight :

Treatment : Milled Clinker of Ciment Fondu®

Animal number : 20090983 - 20090984 - 20090985

Day 1 : 2.280 - 2.365 - 2.180 (expressed in kg)

72 hours : 2.320 - 2.400 - 2.215 (expressed in kg)

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, 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:

Skin irritation and corrosivity of Milled Clinker of Ciment Fondu® was evaluated in the rabbit following a single semi-occluded application to intact skin according to O.E.C.D Guideline No. 404.

0.5 g of Milled Clinker of Ciment Fondu® was applied on the skin of three animals.

The test item was moistened with 0.5 mL of sterile water in order to allow good contact between the test item and the skin. Semi-occlusive dressings held the test item in place for 3 minutes, 1 hour and 4 hours on the skin of the first animal and for 4 hours for the two other animals. The application of the test item induced black coloration of the application site. In order to allow satisfactory conditions for grading, the application site was rinsed using a waterlogged compress at the time of removal of the dressing.

The absence of local reactions to the rinsing procedure with sterile water was confirmed simultaneously: no oedema and no erythema was noted at the issue of this procedure.

Any cutaneous lesion was evaluated approximately one hour, 24, 48 and 72 hours after removal of the dressing. Mean indices were calculated from results obtained from each rabbit at times 24, 48 and 72 hours.

Results obtained as follow for the 3 animals (numbers 20090983, 20090984 & 20090985) :

Erythema : 0 - Oedema : 0

No cutaneous lesion was observed in any animal.

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