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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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

Vehicle:
not specified
Controls:
other: the not treated eye for each animal was used as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washing with physiological saline solution
- Time after start of exposure: 24h

SCORING SYSTEM: DRAIZE system

TOOL USED TO ASSESS SCORE: fluorescein and Optical devices

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Time point:
other: 72h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No eye reaction
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No eye reaction
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 72 h
Score:
ca. 1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: 24 hours after the application of the substance, the redness reaction was not evaluable due to the blue coloration of the eye. In order to give an evaluation the score at 24 h was selected as the higher one of the Draize scale.
Irritation parameter:
conjunctivae score
Remarks:
oedema
Basis:
mean
Time point:
other: 72h
Score:
ca. 0
Max. score:
0
Reversibility:
other: No eye reaction
Other effects:
24 hours after the application of the test substance, the redness of conjunctivae was not evaluable for the blue coloration of the eye.

Any other information on results incl. tables

animal n. Sex/weight (kg) organs symptoms DRAIZE -Grade after: final values
1h 24h 48h 72h 7d
M59 ♀/3.2 cornea Opacity 0 0 0 0 0 0.0
Surface 0 0 0 0 0
iris 0 0 0 0 0 0.0
conjunctivae Redness X X 0 0 0 X
Swelling 1 0 0 0 0 0.0
Lacrimation 1 0 0 0 0
M61 ♀/3.4 cornea Opacity 0 0 0 0 0 0.0
Surface 0 0 0 0 0
iris 0 0 0 0 0 0.0
conjunctivae Redness X X 0 0 0 X
Swelling 1 0 0 0 0 0.0
Lacrimation 2 0 0 0 0
K63 ♂/4.7 cornea Opacity 0 0 0 0 0 0.0
Surface 0 0 0 0 0
iris 0 0 0 0 0 0.0
conjunctivae Redness X X 0 0 0 X
Swelling 0 0 0 0 0 0.0
Lacrimation 1 0 0 0 0
X = evaluation not feasible for blue coloration

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
The test substance is not irritant for the eye.
Executive summary:

The substance to be registered wa tested according to OECD 405, during the test 3 rabbits were used (2 female and 1 male). 24 hours after the application of the test substance, the redness reaction was not evaluable due to the blue coloration of the eye. In order to give an evaluation the score at 24 h was selected as the higher one of the Draize scale. No other effects were observed during the test.

According to the CLP Regulation the substance is not irritant for eye.

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