Trisodium bis[3-[[1-(anilinocarbonyl)-2-oxopropyl]azo]-5-chloro-2-hydroxybenzenesulphonato(3-)]cobaltate(3-)

Endpoint summary

Description of key information

Skin Irritation: not irritant

Eye irritation: not irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

From December 17 to January 9, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IVANOVAS
- Age at study initiation: 2-3 kg
- Weight at study initiation:
- Housing: metal cage
- Diet: standard rabbit food - NAFAG ad libitum
- Water: ad libitum
- Acclimation period: 4 days

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

Type of coverage:

occlusive

Preparation of test site:

other: shaved and scarified

Vehicle:

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

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g of the test material
- Concentration: 50 %

Duration of treatment / exposure:

24 hour

Observation period:

7 days

Number of animals:

3 male and 3 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- 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.

Irritation parameter:

erythema score

Basis:

animal: 164, 169

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal: 165, 166, 167, 168

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No signs of irritation

Irritation parameter:

edema score

Basis:

animal: 164, 169

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 165, 166, 167, 168

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: No signs of irritation

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).

Evaluation of the skin reactions

TIME		After 24 h						After 49 h						After 72 h
SEX		MALE			FEMALE			MALE			FEMALE			MALE			FEMALE
Animal N°		164	165	166	167	168	169	164	165	166	167	168	169	164	165	166	167	168	169
Erythema	a	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Edema	a	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Total	a	2	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Mean	a	0.6			0.6			0			0			0			0
	b	0			0			0			0			0			0
Group mean	a	0.6						0						0
	b	0						0						0
TIME		After 4 days						After 7 days
SEX		MALE			FEMALE			MALE			FEMALE
Animal N°		164	165	166	167	168	169	164	165	166	167	168	169
Erythema	a	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0
Edema	a	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0
Total	a	0	0	0	0	0	0	0	0	0	0	0	0
	b	0	0	0	0	0	0	0	0	0	0	0	0
Mean	a	0			0			0			0
	b	0			0			0			0
Group mean	a	0						0
	b	0						0

mean reaction score
time after exposure	erythema		edema
	intact skin	abraded skin	intact skin	abraded skin
24	0.3	0	0.3	0
72	0	0	0	0
total	0.3	0	0.3	0	0.6

Interpretation of results:

other: CLP criteria not met

Conclusions:

Non irritant

Executive summary:

The substance has been tested According to EPA OPP 81 -5 guideline. Under the conditions of the present experiment the test item was found to cause no irritation when applied to intact and abraded rabbit skin according to the Regulation EC n. 1272/2008.

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:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

October 3, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: IVANOVAS
- Weight at study initiation: 2-3 kg
- Housing:individually in metal cages
- Diet: rabbit food - NAFAG, No. 814, Gossau SG ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 50 ± 10 %
- Photoperiod (hrs dark / hrs light): 10 hour light cycle day.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g

After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 10 ml. of physiological saline

Duration of treatment / exposure:

After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with approximately 10 ml. of physiological saline

Observation period (in vivo):

The rabbits were examined 1, 24, 48, 72 hours and 7 days

Number of animals or in vitro replicates:

The test was performed on 3 male and 3 female adult rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: yes

TOOL USED TO ASSESS SCORE:
The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7

Irritation parameter:

cornea opacity score

Basis:

animal: 167, 168, 169

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

iris score

Basis:

animal: 167, 168, 169

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 167

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal: 168, 169

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs of irritation

Irritation parameter:

chemosis score

Basis:

animal: 167, 168, 169

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: no signs of irritation

Interpretation of results:

other: CLP criteria not met

Conclusions:

Non irritant

Executive summary:

The substance has been tested for eye irritation according to (EPA) § 163.81-4 "Primary eye irritation study". According to the Regulation EC n. 1272/2008 the test material was found to cause no irritation when applied to the rabbit eye mucosa.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

SKIN IRRITATION/CORROSION

A corrosive substance is a substance that produces destruction of skin tissue, namely, visible necrosis through the epidermis and into the dermis, in at least 1 tested animal after exposure up to 4 hour duration.

Three subcategories are provided within the corrosive category 1:

Subcategory 1A where responses are noted following up to 3 minutes exposure and up to 1 hour observation;

Subcategory 1B where responses are described following exposure between 3 minutes and 1 hour and observations up to 14 days;

Subcategory 1C where responses occur after exposures between 1 hour and 4 hours and observations up to 14 days

To classify a substance as irritant, the major criterion is that at least 2 of 3 tested animals have a mean score of ≥ 2,3 - ≤ 4,0.

Category 2:

- 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

- 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; or

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

 

EYE IRRITATION

Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.

Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.

Irreversible effects on the eye (Category 1):

If, when applied to the eye of an animal, a substance produces:

- at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or

- at least in 2 of 3 tested animals, a positive response of corneal opacity ≥ 3 and/or iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.

These observations include animals with grade 4 cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. Substances are also classified in Category 1 if they fulfil the criteria of corneal opacity ≥ 3 or iritis > 1,5 detected in a Draize eye test with rabbits, recognising that such severe lesions usually do not reverse within a 21-day observation period.

The substance does not meet the requirements to be classified in Category 1.

Irritating to eyes (Category 2)

when applied to the eye of an animal, a substance produces:

- at least in 2 of 3 tested animals, a positive response of: corneal opacity ≥ 1 and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival oedema (chemosis) ≥ 2

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 results obtained in the skin and eye irritation studies, the test substance does not need to be classified for skin and eye irritation according to the CLP Regulation (EC) No. 1272/2008.