Reaction product of Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium, sulphuric acid and caustic soda

Endpoint summary

Description of key information

The substance is not a skin irritant, neither is it an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

other: Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978

GLP compliance:

no

Remarks:

Study pre-dates GLP regulations

Specific details on test material used for the study:

- Name as used in the study report: FAT 60149/A.
- Batch No.: Versuch 124 - 4 + 5

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgaü, Germany and MADOERIN AG, 4414 Füllinsdorf, Switzerland
- Age at study initiation: adult
- Weight at study initiation: 2 to 3 kg
- Housing: individual in metal cages
- Diet: ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10/14

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Propylene glycol + saline (70:30 parts)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g
- Concentration: 50%

Duration of treatment / exposure:

24 hours

Observation period:

7 days

Number of animals:

6 (3 male, 3 female)

Details on study design:

TEST SITE
- Area of exposure: Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "Schropfschnapper", Aesculap, Switzerland.
- Gauze patches of 2.5 x 2.5 cm with 0.5 g of the test material were applied to the prepared abraded and intact skin.
- Type of wrap if used: The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- The dressings were removed after a 24 hour application.

OBSERVATION TIME POINTS
- 24, 48 and 72 hours, 4 and 7 days

SCORING SYSTEM
- Due to intensive staining by the test compound erythema was not assessable. For the purpose of calculating the primary irritation index erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975).
- Edema formation was scored on a four point scale (Draize).

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: intact skin

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Remarks:

Study pre-dates GLP regulations

Specific details on test material used for the study:

- Name as used in study report: FAT 60149/A
- Batch No.; Versuch 124 - 4 + 5

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: IVANOVAS, 7964 Kisslegg/Allgau, Germany and MADOERIN AG, 4414 Fülllinsdorf, Switzerland
- Age at study initiation: adult
- Weight at study initiation: 2 to 3 kg
- Housing: individual in metal cages
- Diet: ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 10/14

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g

Duration of treatment / exposure:

- In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 animals (3 male, 3 female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: In 3 animals
- Time after start of exposure: In 3 animals 30 seconds after insertion of the test substance

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: slit lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: results from unrinsed eyes

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: results from unrinsed eyes

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: results from unrinsed eyes

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: results from unrinsed eyes

Irritation parameter:

chemosis score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: results from unrinsed eyes

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: results from unrinsed eyes

Irritant / corrosive response data:

Rinsing the eyes following instillation was of no effect.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

Two in vivo skin irritation studies were conducted according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 “Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.

In the first study, six rabbits were exposed to 0.5 g of the test substance for 24 hours under occlusion dissolved (50%) in propylene glycol + saline (70 : 30 parts) (CIBA-GEIGY, 1979). The substance was applied on a shaved area of 2.5 x 2.5 cm. The patches containing the substance were covered with an impermeable material. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days. In this study, erythema was not assessable due to intensive staining by the test compound. Erythema was assumed to be equal to edema based on the correlation existing (Marzulli and Maibach, Fol. Cosm. Tox. 13, 355, 1975). One animal showed very slight erythema (score 1) on the intact skin after 24 hours, which was reversed after 48 hours. The other animals showed no irritation on the intact skin.

In the second study, six rabbits were exposed to 0.5 g of the test substance on five consecutive days (CIBA-GEIGY, 1980). The substance was dissolved in propylene glycol + saline (70 : 30 parts) and applied on the shaved back, using gauze patch of 4 x 5 cm. The patches were covered with an impermeable material. The skin reaction was scored after 24 hours after the first four applications and after 8 hours after the fifth application. The skin reaction was recorded again on days 8, 9 and 10 (recovery period). Body weights were recorded at initiation and day 3 and 5 of the treatment period and at day 8 and 10 of the observation period. No erythema or edema was observed after day 1, three animals showed very slight erythema (score 1) and very slight edema (score 1) after day 2. After day 3, four animals showed very slight erythema and very slight edema and one animal showed slight erythema (score 2) and slight edema (score 2). After 5 days, one animal was given a score 2 for both erythema and edema and the other animals a score 1. The effect progressed into score 2 after 8 days in one animal. No reversal was observed up to day 10. The animals showed decreased body weight during the application period, but clear recovery of the body weight at the end of the observation period.

Eye

Two reliable in vivo eye irritation studies were conducted according to the Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.

In the first study, six rabbits received 0.1 g of the test substance in the conjunctival sac of the left eye and the right eye was not treated and served as control (CIBA-GEIGY, 1979). In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7. All three rabbits with unrinsed eyes showed scattered or diffuse opacity of the cornea (score 1) on day 1 and day 2, which was reversed on day 3. The iris was observed to be normal (score 0), while the redness of the conjunctivae was observed to be above normal (score 1) for two of the three animals with unrinsed eyes on day one only and some swelling (chemosis) with score 1 was also seen in these animals on day one.

In the second study, six rabbits received 0.1 g of the test substance in the conjunctival sac of the left eye during 5 consecutive days and the right eye was not treated and served as control (CIBA-GEIGY, 1979). No signs of irritation were observed; all scores for cornea, iris and conjunctivea were 0 throughout the observation period.

Justification for classification or non-classification

Based on the available data, the substance does not have to be classified for skin irritation, nor for eye irritation, according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.