Registration Dossier
Registration Dossier
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EC number: 208-863-7 | CAS number: 544-17-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
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
Test material
- Reference substance name:
- Calcium diformate
- EC Number:
- 208-863-7
- EC Name:
- Calcium diformate
- Cas Number:
- 544-17-2
- Molecular formula:
- CH2O2.1/2Ca
- IUPAC Name:
- calcium diformate
- Details on test material:
- - Name of test material (as cited in study report): calcium formate technical
- Substance type: salt
- Physical state: solid
- Analytical purity: >98%
- Purity test date: 1999-July-06
- Lot/batch No.: H0509
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Löhndorf, Germany
- Age at study initiation: 3.5 to 4 months
- Weight at study initiation: 1.8 - 2.1 kg
- Housing: singly in cages with special restrainers to avoid possibility of skin irritation by excrements or urine
- Diet: standard diet ALTROMIN 2023 ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3
- Humidity (%): 50+/-20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg
VEHICLE
- Amount applied: not specified - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 3 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- coverage: gauze patch
- Type of wrap if used: semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 hours
SCORING SYSTEM: according to Draize, table contained in OECD 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- no skin reaction in any animal at any reading
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Calcium diformate was not irritating to intact rabbit skin
- Executive summary:
The potential of CaFo for skin irritation was examined in a GLP OECD guideline No. 404 study using three male Himalayan rabbits. A dose of 500 mg/animal as a paste with water was applied to the shaved and intact dorsal skin. The test area was then covered with a gauze patch which was held in contact by means of semi-occlusive dressing. The skin sites were evaluated according to the table contained in the test guideline (adopted in 1992) immediately before the application of the test substance and after the 4-hour exposure. The scores were taken 60 min, 24, 48 and 72 hours after patch removal.
There was no skin reaction in any animal at any reading, i.e. the mean erythema and edema scores were 0 at all readings, and there were no pathological changes noted. Therefore, CaFo was not irritating to the skin (LPT, 1999). The study is considered to be fully valid for assessment.
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