Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate

Endpoint summary

Description of key information

Pigment Red 57-Sr is not irritating to skin and eyes as determined in GLP and OECD testing guideline compliant studies in rabbits (BASF 1992).

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:

Erythema score not assessable due to red staining of the test substance

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

- Physical state: powwder, red
- Analytical purity: the test substance has not been fully characterized analytically.
- Lot/batch No.: CS-485
- Stability under test conditions: has not been determined analytically.
- Storage condition of test material: room temperature
- Name of test material (as cited in study report): LITHOL RUBIN D 4569-SR-LACK

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, D
- Age at study initiation: young adult
- Mean weight at study initiation: Males: 2.7 kg, females: 2.4 kg
- Clipping of the fur: at least 15h
- Housing: individually
- Diet: Kliba-Labordiaet 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the unchanged test substance has been moistened with aqua bidest; because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible.

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

2 males, 1 female

Details on study design:

TEST SITE
- Area of exposure: upper third ofthe back or flanks, test patch 2.5 CM X 2.5 CM
- Type of wrap if used: test patches were secured in positino with a porous dressing (four layers of absorbent gauze + porous bandage).

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the exposure with lutrol and lutrol/water (1:1)

READINGS: 30 - 60 minutes after removal of the test patches and 24h, 48 h, 72 h, 8d after the beginning of application

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Max. score:

4

Reversibility:

other: no effects observable

Remarks on result:

other: not determineable

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Erythema score could not be read because of staining due to the colour of the test substance up to the 72 h reading. Day 8 reading no erythema were seen (score 0).

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:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

eyes were not washed out

GLP compliance:

yes

Specific details on test material used for the study:

- Physical state: powder, red
- Analytical purity: the test substance has not been fully analytically characterized
- Lot/batch No.: CS-485
- Stability under test conditions: the stability has not been determined analytically
- Storage condition of test material: room temperature

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult
- Mean weight at study initiation: Males: 3.6 kg, females: 3.8 kg
- Clipping of the fur: at least 15h
- Housing: individually
- Diet: Kliba-Labordiaet 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Vehicle:

unchanged (no vehicle)

Controls:

other: other untreated eye

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume ( (about 58 mg of the comminuted test substance)

Duration of treatment / exposure:

single application

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

1 male, 2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was not washed out

READINGS: 1h, 24h, 48h, 72h after application

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 #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal: # 1 and # 3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

Discharge after one hour

Exposition: Single application to the conjunctival sac of the eyelid; the substance is not washed out
Animal	Reading	Cornea	Iris	Conjunctiva		Additional findings
		Opacity		Redness	Chemosis
1	1 h	0	0	1	0	-
2	1 h	0	0	1	0	-
3	1 h	0	0	1	0	-
1	24 h	0	0	0	0	-
2	24 h	0	0	2	0	-
3	24 h	0	0	0	0	-
1	48 h	0	0	0	0	-
2	48 h	0	0	1	0	-
3	48 h	0	0	0	0	-
1	72 h	0	0	0	0	-
2	72 h	0	0	0	0	-
3	72 h	0	0	0	0	-
mean animal 1	24 - 72 h	0.00	0.00	0.00	0.00
mean animal 2	24 - 72 h	0.00	0.00	1.00	0.00
mean animal 3	24 - 72 h	0.00	0.00	0.00	0.00
mean total	24 - 72 h	0.00	0.00	0.33	0.00

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

Pigment Red 57-Sr was investigated for skin and eye irritation in rabbits (BASF 1992). Both studies were performed following the principles of GLP and according to OECD testing guidelines (no. 404 and 405). A sample of commercial quality was tested. No indication of skin irritation was observed, with the limitation that the erythema score could not be read because of staining due to the colour of the test substance up to the 72 h reading. At the reading on day 8 no erythema were seen. Application to the eyes of three animals caused transient mild reddening of the conjunctivae of one animal.

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.