[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2 June 2004 to 5 June 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Calcium carbonate

EC Number:

207-439-9

EC Name:

Calcium carbonate

Cas Number:

471-34-1

Molecular formula:

CH2O3.Ca

IUPAC Name:

calcium carbonate

Test material form:

solid: bulk

Details on test material:

Supplier: Solvay S.A
Trade name: PCC
Batch number: ANMM001172
Description: White powder

Mineral composition:
Calcium carbonate: > 98.5%
Impurities: Mg, Fe, Al, SO4, Cl

Other information:
Mean particle size: 0.2 - 2.0 µm
pH (10% suspension): 9.7 - 9.9
Specific gravimetry: 2.71

Specific details on test material used for the study:

Bulk calcium carbonate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Source: David Percival Ltd, Moston, Sandbach, Cheshire UK.
- Weight: 2.0 to 3.5 kg
- Age: 12 - 20 weeks old.
- Acclimation period: at least 5 days
- Housing: the animals were individually housed in suspended metal cages
Free access to mains drinking water and food (Certified Rabbit Diet code 5322) allowed throughout the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g of test material moistened with 0.5 mL of distilled water

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after removal of the patches

Number of animals:

3 male animals

Details on study design:

TEST SITE
- Area of exposure: Dorsal/ flank - 2.5 cm x 2.5 cm area
- % coverage: No data
- Type of wrap if used: The cotton gauze patch was secured in position with a strip of adhesive tape and the trunk of each rabbit was then wrapped in an elasticated corset.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Mean scores calculated according to the criteria described in Regulation (EC) No 1272/2008

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: Mean scores calculated according to the criteria described in Regulation (EC) No 1272/2008

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Other effects:

No data

Any other information on results incl. tables

Table 1: Individual Skin Reactions

Skin reaction	Observation Time	Individual scores – Rabbit Number and Sex			Total
		29 Male	30 Male	31 Male
Erytheme/Eschar Formation	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	0 0 0 0	( 0 ) 0 ( 0 ) 0
Oedema Formation	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	0 0 0 0	( 0 ) 0 ( 0 ) 0
Classification:                                          NON-IRRITANT

No evidence of skin irritation was noted during the study

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No evidence of skin irritation or corrosive effects were noted during the study. All the indivdual scores were 0; hence, the mean scores for 24, 48 and 72 hours for each animal were also 0. PCC is therefore non-irritating to rabbit skin and does not require classification according to the criteria described in Regulation (EC) No 1272/2008.