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Toxicological information

Skin irritation / corrosion

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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:
1986
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

Constituent 1
Chemical structure
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

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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