Reaction products of copper phthalocyanine, sulfuric acid, and sodium carbonate

Eye irritation

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

mean

Time point:

other: 72h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No eye reaction

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No eye reaction

Results 3

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.

Results 4

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.