Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex

Endpoint summary

Description of key information

Pigment Red 48:4(Mn) caused no sign of skin and eye irritation.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

acceptable restrictions, mostly due to reduced reporting in times before GLP

Principles of method if other than guideline:

Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance. Exposure of 1, 5 and 15 minutes was not done in this experiment

GLP compliance:

no

Specific details on test material used for the study:

- Physical state: solid
- Name of test material (as cited in study report): Litholechtscharlach 4300, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100%

Species:

rabbit

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Breeder
- Weight at study initiation: female: 3.06 kg, male: 3.23 kg

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Concentration: 50 % aqueous solution, creamy

Duration of treatment / exposure:

20 hour(s)

Observation period:

8 days

Number of animals:

1 female, 1 male

Details on study design:

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h exposition will serve as approximation.

TEST SITE
- Area of exposure: dorsal
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: cotton lobe

SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

other: red compound residues

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not determinable

Other effects:

Red substance residues after 24 h. No abnormality and no red substance residues detected after 8 d.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

partly limited documentation, only 85 mg applied

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

application amount (50 µl, ca 85 mg)

Principles of method if other than guideline:

BASF test

GLP compliance:

no

Specific details on test material used for the study:

- Physical state: solid
- Name of test material (as cited in study report): Litholechtscharlach 4290, C.I.Pigmentred 48:4, Monoazofarbstoff.
- Analytical purity: 100 %

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler (Breeder)
- Weight at study initiation: 2.68 kg (female), 3.22 kg (male)

Vehicle:

unchanged (no vehicle)

Controls:

other: talcum (amorph) into the other eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
- Concentration: undiluted

Duration of treatment / exposure:

Treatment was once. The eye was left unwashed, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage, which would probably be less severe if it had been washed out after 1 day.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

1 female, 1 male

Details on study design:

SCORES
Descriptive scores of the raw data have been converted to Draize numerical scores

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

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 irritation was investigated in three rabbit studies (BASF 1973 and 1974, Ciba 1972) and in all of them, red staining of the skin by the red pigment interfered with erythema scoring in the first days after application. In the key study, two rabbits were treated with a commercial product for up to 20h using occlusive conditions. No abnormalities were detected at the 1 and 8 day readings (BASF 1973 and 1974). Very mild erythema were observed at the 24 and 72h reading in a study following the standard procedure of the The Food and Drug Administration of the U.S.A. in The Federal Register (17 September, 1964 § 191.11) (Ciba 1972). This involves 24h occlusive application and represents a worse case than the 4h semi-occlusive application required by the OECD testing guideline for skin irritation. Overall, Pigment Red 48:4 is considered to be non irritating to skin.

Assessment of eye irritation was performed in three rabbit studies performed according to a protocol similar to OECD testing guideline 405. The main differences are that applied amounts are slightly less and that there are limited details on non-irritation related parameters such as body weight. Findings were either completely absent (Ciba 1972) or mild and reversible within 72h (BASF 1973 and 1974). Therefore, the deviations from the OECD testing guidelines are acceptable. It is concluded that Pigment Red 48:4 is not irritating to eyes.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for irritation according to Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008.