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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
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:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: US Federal Register 38 No 187 § 1500.41
Version / remarks:
24h occlusive exposure, investigation of hypoderm and underlying muscles
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Brominated chlorinated copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, wherein the number of bromines is equal to or more than 10 and less than 16, and the number of chlorines is equal to or more than 0 and less than 7
EC Number:
701-428-7
Molecular formula:
C32HxBryClzCuN8
IUPAC Name:
Brominated chlorinated copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, wherein the number of bromines is equal to or more than 10 and less than 16, and the number of chlorines is equal to or more than 0 and less than 7
Test material form:
solid: particulate/powder
Details on test material:
green powder
Specific details on test material used for the study:
Heliogengrün 9140

Test animals

Species:
rabbit
Strain:
other: Albino
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 3-4kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least three days

ENVIRONMENTAL CON DITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 34 - 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
intact and scarified sites were tested on the same animal
Vehicle:
other: 50% Lutrol 400 (= PEG 400) in water
Remarks:
for moistioning
Controls:
other: yes, untreated skin sites
Amount / concentration applied:
0.5g per site (1g per animal)
Duration of treatment / exposure:
24h
Observation period:
7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6.25cm2
- Type of wrap if used: PVC foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm vehicle
- Time after start of exposure:24h

OBSERVATION TIME POINTS
24h and 72h for skin findings, 7 days for hypoderm and muscle

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, since no findings
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable, since there were no findings
Irritation parameter:
erythema score
Basis:
other: all animals
Time point:
24 h
Remarks on result:
not determinable
Remarks:
The green test material had stained the skin.
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: Not applicable, since no findings
Remarks on result:
other: For half of the animals, green staining of the skin interfered with scoring.
Irritant / corrosive response data:
At the end of treatment (24h reading), scoring for erythema was not possible as the green test item had stained the skin.
At the 72h reading, scoring was still not possible for 3 animals. For the other 3 animals, no erythema (score = 0) was observed. Findings were equal for intact and scarified skin.

Edema was not observed in any animal at any time point (Score = 0).
Other effects:
There were no adverse findings on the hypoderm and muscles underlying the treated skin sites.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met