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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
No evidence of skin or eye irritation effects was noted during the studies.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- 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
- 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)
- Specific details on test material used for the study:
- Bulk calcium carbonate
- 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 - 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 - 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
- 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
- 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.
Referenceopen allclose all
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 June 2004 to 24 June 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eye served as control
- Amount / concentration applied:
- 0.1 mL of the test material (~61 mg)
- Duration of treatment / exposure:
- Animals were exposed to the test material for up to 72 hours.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3 male animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
Not specified
SCORING SYSTEM: Assessment of ocular damage/ irritation was made according to Draize. Ocular irritancy potential of the test material was determined using a modified version of the system described by Kay and Calandra.
TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope - Irritation parameter:
- cornea opacity 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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Mean scores calculated according to the criteria described in Regulation (EC) No 1272/2008
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Mean scores calculated according to the criteria described in Regulation (EC) No 1272/2008
- Irritation parameter:
- chemosis 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 corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes one hour after treatment.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48 hour observations.
All treated eyes appeared normal at the 72 hour observation. - Other effects:
- The initial pain reaction was grade 2 (rabbit blinks and tries to open eye but reflex closes it, slight initial pain).
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There were no corneal or iridial effects or chemosis noted during the study after 24 hours of exposure; hence, the mean scores for 24, 48 and 72 hours for each animal were 0. The mean scores for 24, 48 and 72 hours for each animal for conjunctivae redness, although above 0, were below the limits for classification as irritating to eyes (Category 2) and the effects were fully reversible within an observation period of 21 days. PCC is therefore non-irritating to eyes and does not require classification according to the criteria described in Regulation (EC) No 1272/2008.
Referenceopen allclose all
Table 1: Individual scores and individual total scores for ocular irritation
Rabbit number and sex |
83 Male (IPR = 2) |
26 Male (IPR = 2) |
27 Male (IPR = 2) |
|||||||||
Time after treatment |
1 h |
24 h |
48 h |
72 h |
1 h |
24 h |
48 h |
72 h |
1 h |
24 h |
48 h |
72 h |
CORNEA E= degree of opacity F=area of cornea involved |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
0
0 |
IRIS D |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
CONJUNCTIVAE A=Redness B=Chemosis C=Discharge |
1 1 1 |
1 0 1 |
1 0 0 |
0 0 0 |
1 1 1 |
1 0 1 |
1 0 0 |
0 0 0 |
1 1 1 |
1 0 1 |
1 0 0 |
0 0 0 |
IPR = Initial Pain Reaction
Table 2: Mean Scores for Ocular Irritation
Skin Reaction |
Mean scores for 24, 48 and 72 hours |
||
- |
83 Male |
26 Male |
27 Male |
Cornea |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
Conjunctivae - redness |
2/3 = 0.67 |
2/3 = 0.67 |
2/3 = 0.67 |
Conjunctivae – chemosis |
0 |
0 |
0 |
No corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes on hour after treatment.
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48 -hour observations.
All treated eyes appeared normal at the 72 hour observation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.
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