Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)

Endpoint summary

Description of key information

In a primary skin and eye irritation study, no skin or eye irritating effects were observed in six English Silver rabbits. (BASF, 1972)

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

other: English Silver

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Diet: ad libitum, standard diet (NAFAG, Gossau SG)
- Water: ad libitum

Type of coverage:

occlusive

Preparation of test site:

other: shaved and scarified

Vehicle:

other: polyethylene glycol

Controls:

other: Untreated skin served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

see observation period; no washing was done

Observation period:

72 hours

Number of animals:

6 (3x shaved; 3x abraded)

Details on study design:

TEST SITE
- Area of exposure: whole back and flanks
- coverage: 2.5x2.5 cm gauze patch soaked with the test substance
- Type of wrap if used: plastic film fixed with adhesive tape

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite
raising 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: scarified skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: scarified skin

Irritant / corrosive response data:

No irritating effects were seen in any of the six animals.

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the U.S Association of Food and Drug Officials (AFDO)

Deviations:

not specified

GLP compliance:

no

Species:

rabbit

Strain:

other: English Silver

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Housing: individually
- Diet: ad libitum, standard diet (NAFAG, Gossau SG)
- Water: ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

other: Adjacent eye served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 g

Duration of treatment / exposure:

see observation period; washing out was conducted for 3/6 animals after 30 sec.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 10 mL lukewarm water
- Time after start of exposure: 30 sec

SCORING SYSTEM: According to Draize et al. (1959)

TOOL USED TO ASSESS SCORE: hand-slit lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: unrinsed

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: unrinsed

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

other: unrinsed

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: unrinsed

Irritant / corrosive response data:

A conjunctival effect was only observed in one animal when rinsing the eye. No other irritating parameters were detected. The irritation index was found to be 0 for the cornea, 0 for the iris and 0.2 for the conjunctivae.

Eyes not rinsed:

	Rabbit 4			Rabbit 5			Rabbit 6
Days after application	Cornea	Iris	Conjunctiva	Cornea	Iris	Conjunctiva	Cornea	Iris	Conjunctiva
1	0	0	0	0	0	0	0	0	0
2	0	0	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0	0	0
7	0	0	0	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin Irritation

In a primary skin irritation, 0.5 g of the test substance suspended in polyethylene glycol was applied to the intact and abraded skin of 6 English Silver rabbits (3/sex) (BASF, 1972). All animals were shaved and half of them were slightly scarified at the shaved skin site. The test substance was applied for 24 hours under an occlusive dressing. The animals were then observed for 72 hours. Irritation was scored by the method of Draize.

No irritations were observed either on the intact or the abraded skin sites. Therefore the substance is not regarded as irritating to the skin.

 

Eye Irritation

In a primary eye irritation study, 0.1 g of the undiluted test substance was instilled into the conjunctival sac of the right eye of 6 English Silver rabbits (3/sex) (BASF, 1972). The test substance was not washed out in 3 of the 6 and the left eye served as a control. Animals were observed for a period of 7 days. Irritation was scored by the method of Draize et al.(1959) after 24 hours, 72 hours and 3, 4 and 7 days.

No irritating effects in the form of corneal opacity, iritis, conjunctival redness and chemosis were observed in all six animals after 24 and 72 hours. Conclusively the test substance is not regarded as irritating to the eye.

Justification for selection of skin irritation / corrosion endpoint:
Non GLP study. Meets general scientific standards.

Justification for selection of eye irritation endpoint:
Non GLP study. Meets general scientific standards.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance does not need to be classified and labelled for eye and skin irritation under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled for eye and skin irritation under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.