Registration Dossier
Registration Dossier
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EC number: 233-279-4 | CAS number: 10102-90-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2014-07-07 - 2014-08-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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
- Reference substance name:
- Diphosphoric acid, copper salt
- EC Number:
- 233-279-4
- EC Name:
- Diphosphoric acid, copper salt
- Cas Number:
- 10102-90-6
- Molecular formula:
- Cu.xH4O7P2
- IUPAC Name:
- diphosphoric acid, copper salt
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): diphosphoric acid, copper salt
- Physical state: light blue, solid powder
- Analytical purity: > 80% (Cu content > 34%)
- Impurities (identity and concentrations): water < 18%, free orthophosphate < 2%
- Lot/batch No.: 9000025486
- Storage condition of test material: 15-25 °C
- Sterility: unsterile
Test animals
- Species:
- rabbit
- Strain:
- other: Zika
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kaninchenbetrieb Kock, Warnkenhagen, Germany
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 3.0 - 3.1 kg
- Housing: Test animals were hold single caged
- Diet: conventional laboratory diet (a half-and-half blend of "Holstenstolz Kaninchenverbrauchsfutter 2, Type038" [Wilhelm Stroeh jr. GmbH & Co. KG, Germany] and "Rabbit maintenance, MuesliMash", [ssniff Spezialdiäten GmbH, Germany], ad libitum
- Water: tap water (drinking quality) ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: moistened with 500 µL water
- Controls:
- other: untreated skin areals of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- Animal 1: 3 min, 1 and 4 h (on different patches, respectively)
Animals 2 and 3: 4 h - Observation period:
- Up to 8 days
Scoring time points:
Animal 1: 3 min, 1 and 4 h immediately after exposure
Animals 1-3: 1, 24, 48 and 72 h after patch removal - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed with water
- Time after start of exposure: 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicabe
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicabe
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicabe
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicabe
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicabe
- Irritant / corrosive response data:
- There were no erythema and edema observed at any given timepoint.
- Other effects:
- Pretest with one animal was performed to determine the corrosive properties of the test material. Therefore the exposure was terminated after 3 minutes, 1 and 4 hours and scored, respectively. Every scored timepoint for erythema and edema was 0.
No further local or systemic effects were observed during the study period.
No effects on body weight (gain) were noted.
Any other information on results incl. tables
Table 1: Scoring of skin lesions
Skin reaction |
Observation time (following patch removal after 4 h exposure, if not otherwise indicated) |
Individual scores – Rabbit number and sex |
||
2014-55 female |
2013-63 female |
2013-64 female |
||
Erythema/Eschar formation |
Immediately after 3 minutes exposure |
0 |
- |
- |
Immediately after 1 hour exposure |
0 |
- |
- |
|
Immedieately after 4 hours exposure |
0 |
- |
- |
|
1 hr |
0 |
0 |
0 |
|
24 hrs |
0 |
0 |
0 |
|
48 hrs |
0 |
0 |
0 |
|
72 hrs |
0 |
0 |
0 |
|
Mean score (24-72 hrs) |
0 |
0 |
0 |
|
Oedema formation |
Immediately after 3 minutes exposure |
0 |
- |
- |
Immediately after 1 hour exposure |
0 |
- |
- |
|
Immediately after 4 hours exposure |
0 |
- |
- |
|
1 hr |
0 |
0 |
0 |
|
24 hrs |
0 |
0 |
0 |
|
48 hrs |
0 |
0 |
0 |
|
72 hrs |
0 |
0 |
0 |
|
Mean score (24-72 hrs) |
0 |
0 |
0 |
|
Table 2: Bodyweight and weight gain in kilograms
Rabbit number and sex |
Individual bodyweight (kg) |
Bodyweight change (kg) |
|
Day 0 |
Day 3 and 8 |
||
2014-55 female |
3.02 |
3.19 |
+ 0.17 |
2014-63 female |
3.00 |
3.06 |
+ 0.06 |
2014-64 female |
3.10 |
3.17 |
+ 0.07 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material caused under the conditions of the test of "Acute dermal irritation/corrosion" (OECD 404) no symptoms of irritation/corrosion.
- Executive summary:
The test material caused under the conditions of the test of "Acute dermal irritation/corrosion" (OECD 404) no symptoms of irritation/corrosion.
The individual mean values of the erythema/eschar and edema from gradings at 24, 48 and 72 hours were 0 in all three animals. Therefore, the test material is "not classified" according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures.
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