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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:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
EC Number:
205-685-1
EC Name:
29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
Cas Number:
147-14-8
Molecular formula:
C32H16CuN8
IUPAC Name:
[29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Batch no SF20927
- blue powder
- storage conditions: room temperature in the dark
- no data on purity available

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2 - 3.5kg
- Housing: individulally
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30-70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: June 1 2004 To: June 8 2004

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
4h
Observation period:
24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Type of wrap if used: surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure:4h

OBSERVATION TIME POINTS
24, 48 and 72 hours

SCORING SYSTEM: Draize
- Method of calculation: according to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: reversibility is not applicable, as there were no findings.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48h

Any other information on results incl. tables

 

 

Skin Reaction

 

 

Observation Time

IndividualScores-Rabbit

Numberand sex

 

 

Total

 

 

104 Male

 

105 Male

 

106 Male

 

1 Hour

1 STA

1 STA

1 STA

( 3 )

Erythema/Eschar

24 Hours

1 STA

1 STA

1 STA

3

Formation

48 Hours

O STA

O STA

O STA

( 0 )

 

72 Hours

O STA

O STA

O STA

0

 

1 Hour

0

0

0

( 0 )

 

Oedema Formation

24 Hours

0

0

0

0

 

48 Hours

0

0

0

( 0 )

 

72 Hours

0

0

0

0

Sum of 24 and 72-hour Readings (S)

:

3

 

 

Primary Irritation Index (S/6)

:

3/6=0.5

 

 

STA = Blue colored staining of the skin

(  ) =Total values not used for calculation of primary irritation index

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Copper phthalocyanine is not irritating to rabbit skin.