Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex

Endpoint summary

Description of key information

Skin

In vivo

Rabbit (m/f) (OECD 404): not irritating (BASF AG, 1984)

in vitro

Actually there is no date available

Eye

In vivo

Rabbit (m/f) (OECD 405): not irritating (BASF AG, 1984)

Respiratory system

Actually, there is no information available.

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:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Remarks:

Department of Toxicology (BASF AG)

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG
- Weight at study initiation: mean 2.91 kg (males), 2.59 kg (females)
- Housing: individually in stainless steel cages with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm, Muskator-Werke, D-4000 Duesseldorf 1, FRG (about 130 g per animal per day)
- Water (e.g. ad libitum): tap water (about 250 ml per animal per day )
- Acclimation period: at least 8 days before the beginning of the study

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

Type of coverage:

semiocclusive

Preparation of test site:

other: Clipping of the fur at least 15 hours before the beginning of the study

Vehicle:

water

Controls:

other: untreated skin site of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mm layer suspension (thus about 0.5 g of the test substance)
- Concentration (if solution): 50%

Duration of treatment / exposure:

4 h

Observation period:

8 days

Number of animals:

3 (1 male/2 female )

Details on study design:

TEST SITE
- Area of exposure: third of the back or flank
- Type of wrap if used: test patch (2.5 x 2.5 cm) secured in position with a porous dressing (4 layers of absorbent gauze + porous bandage)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h


SCORING SYSTEM:
Evaluation of erythema and edema:
0 - None
1 - Very slight
2 - Well-defined
3 - Moderate to severe
4 - Severe

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 8 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Animal1: male, 2.91 kg

Animal 2: female, 2.69 kg

Animal 3: female, 2.49 kg

Readings:

Readings	Animal	Erythema	Edema	Additional findings
4 h	1	1	0
	2	1	0
	3	1	0
24 h	1	0	0
	2	0	0
	3	1	0
48 h	1	0	0
	2	0	0
	3	0	0
72 h	1	0	0
	2	0	0
	3	0	0
8 d	1	0	0
	2	0	0
	3	0	0
mean 24 - 72 h	1	0.0	0.0
	2	0.0	0.0
	3	0.3	0.0
mean 24 - 72 h		0.1	0.0

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tested for in vivo skin irritation following OECD 404. Under the experimental conditions the substance did not show any skin irritation properties.

Executive summary:

The substance was tested for in vivo skin irritation following OECD 404. Three NZW rabbits (1 male and 2 females) were tested in a semi-occlusive test for 4 h. Under the experimental conditions the substance did not show any skin irritation properties.

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:

no

GLP compliance:

yes

Remarks:

Department of Toxicology, BASF AG

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG
- Weight at study initiation: mean 2.76 kg (males), 2.87 kg (females)
- Housing: individually in cages made of stainless steel with wire mesh walk floors (floor area 40 cm x 51 cm)
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm (Muskator-Werke D-4000 Düsseldorf 1, FRG; about 130 g per animal per day)
- Water (e.g. ad libitum): tap water (about 250 ml per animal per day )
- Acclimation period: at least 8 days before the beginning of the study


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

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml bulk volume (about 90 mg) of the ground test substance

Duration of treatment / exposure:

single application

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3 (2 females, 1 male)

Details on study design:

SCORING SYSTEM:

Cornea
(A) Opacity-degree of density (area most dense taken for reading)
0 = No opacity
1 = Scattered or diffuse area, details of iris clearly visible
2 = Easily discernible translucent areas, details of iris slightly obscured
3 = Opalescent areas, no details of iris visible, size of pupil barely discernible
4 = Opaque, iris invisible

(B) Area of cornea involved
1 = One quarter (or less) but not zero
2 = Greater than one quarter, but less than half
3 = Greater than half, but less than three quarters
4 = Greater than three quarters, up to whole area

Iris
(A) Values
0 = Normal
1 = Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination af any thereof) iris still reacting to light (sluggish reactions is positive)
2 = No reaction to light, hemorrhage, gross destruction (any or all of these)

Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0 = Vessels normal
1 = Vessels definitely injected above normal
2 = More diffuse, deeper crimson red, individual vessels not easily discernible
3 = Diffuse beefy red

(B) Chemesis
0 = No swelling
1 = Any swelling above normal (includes nictitatinq membrane)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids about half closed to completely closed

(C) Discharge
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no readable effects

Irritation parameter:

conjunctivae score

Basis:

animal: 1, 2 and 3

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.3

Max. score:

2

Reversibility:

fully reversible within: 8 days

Irritation parameter:

cornea opacity score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Animal 1: female, 2.95 kg

Animal 2: female, 2.78 kg

Animal 3: male, 2.76 kg

Readings:

Readings	Animal	cornea		Iris	conjunctiva			Symptons
		opacity	area		redness	swelling	discharge
1 h	1	0	0	0	0**	2	2	s
	2	0	0	0*	0**	2	2	s
	3	0	0	0*	0**	2	2	s
24 h	1	0	0	0	2	2	1
	2	0	0	0*	2	2	1	s
	3	0	0	0*	2	2	1	s
48 h	4	0	0	0	1	1	0
	5	0	0	0	1	1	0
	6	0	0	0	1	1	0
72 h	1	0	0	0	1	0	0
	2	0	0	0	1	1	0
	3	0	0	0	1	1	1
8 d	1	0	0	0	0	0	0
	2	0	0	0	0	0	0
	3	0	0	0	0	0	0
mean 24 - 72 h	1	0		0	1.3	1.0
	2	0		0	1.3	1.3
	3	0		0	1.3	1.3
Mean		0		0	1.3	1.2

s: irritation index could not be read because of staining due to the color of the test substance

*: if in 1 or 2 animals assessments referring to the same characteristic cannot be made at a particular reading, the mean rounded to the nearest whole number of the values that can be read is inserted instead

**: if in all animals assessments referring to the same CO characteristic cannot be made at a particular reading, zero is inserted instead

Interpretation of results:

other: not classified under Regulation 1272/2008

Conclusions:

The substance was tested for in vivo eye irritation following OECD 405. Under the experimental conditions the substance did not show any eye irritation properties.

Executive summary:

The substance was tested for in vivo eye irritation following OECD 405. A single eye of three NZW rabbits (1 male and 2 females) was exposed in a single application to the substance (unchanged, powder form) and the irritation parameter recorder over a period of 8 days. The substance was tested for in vivo eye irritation following OECD 405.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

There are valid in vivo data available for the assessment of the skin and eye irritation potential of the test substance.

Skin

The potential of the test substance to cause acute dermal irritation or corrosion was assessed in vivo in rabbits according to OECD guideline 404. In this study the test article did not show any irritative/corrosive potential by a single topical application of 0.5 g of the test substance to the intact skin of 3 White Vienna rabbits for 4 hours under semiocclusive conditions. The average score (24 to 72 hours) for irritation for erythema and for edema were recorded, with the erythema being fully reversible within 48 hours.

 

Eye

The potential of the test substance to cause eye irritation or corrosion was assessed in 3 rabbits according to OECD guideline 405. The test substance produced moderate conjunctival reactions (reddening and swelling) were observable in all animals for 24 h after exposure, however, the eye was exposed to bulk volume (powder) of the test substance, thus, initial irritation can be explained by mechanical effects. Those effects were fully reversible within 8d. No other effects were reported.

 

Respiratory system

Actually, there is no information available.

 

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008) the following classifications apply:

 

Skin irritant cat2:

1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; o

3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

 

 

Eye irritant Cat 2:

at least in 2 of 3 tested animals, a positive response of:

1)     corneal opacity ≥ 1 and/or

2)     iritis ≥ 1, and/or

3)      conjunctival redness ≥ 2 and/or

4)      conjunctival oedema (chemosis) ≥ 2

5)     calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

Based on the result of the in vivo studies for skin and eye irriation no classification is applied under Regulation 1272/2008.