Registration Dossier
Registration Dossier
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EC number: 942-100-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 21, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Pre GLP.
Test material
- Reference substance name:
- Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate
- EC Number:
- 942-100-5
- Molecular formula:
- Not applicable: UVCB substance
- IUPAC Name:
- Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK ltd.
- Weight at study initiation: 3.4 - 3.8 kg
- Housing: in individual cages (Drahtkäfige type III-Hoch)
- Diet (e.g. ad libitum): standard diet "Sniff K4" (Versuchstierdiäten GmbH) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 45 - 64 %
- Air changes : 10 canges per day
- 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
500 mg of test substance have been dissolved in water and applied on rabbits - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 male
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Beiersdorf No. 2342
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: L76
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: L76
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: L77
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: L77
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: K83
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: K83
- Time point:
- other: 7 d
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- fully reversible
Any other information on results incl. tables
4h exposition data:
| animal n. | Sex/weight (kg) | DRAIZE -Grade after: | final values | ||||||||||
| 1h | 24h | 48h | 72h | 7d | |||||||||
| E | O | E | O | E | O | E | O | E | O | E | O | ||
| L76 | M/3.8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
| L77 | M/3.4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
| K83 | M/3.4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
| E = Erythema | |||||||||||||
| O = Oedema | |||||||||||||
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not irritant
- Executive summary:
The substance to be registered has been tested according to OECD 404. The test substance was applied on the shaved skin of three rabbits.
No erythema and no edema were observed during the test.
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