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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2 June 2004 to 5 June 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study. As this study is being used for read-across, the reliability has been amended to reflect this.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Calcium carbonate (Precipitated calcium carbonate)
IUPAC Name:
Calcium carbonate (Precipitated calcium carbonate)
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

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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: Mean scores for all animals
Time point:
other: 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: Mean scores calculated according to the criteria described in Regulation (EC) No 1272/2008
Irritation parameter:
edema score
Basis:
other: Mean scores for all animals
Time point:
other: 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable
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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.