Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The method given in the "Hazardous Substance Regulations" unter the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex

EC Number:

252-525-1

EC Name:

Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex

Cas Number:

35355-77-2

Molecular formula:

C21H12MnN2O6S

IUPAC Name:

manganese(2+) hydrogen 3-oxido-4-[(E)-(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2-carboxylate

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: purple powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 11 - 16 weeks
- mean weight at study initiation: males 2.57 kg and females 2.60 kg
- Housing: animals were caged singly in an experimental room
- Diet: a commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: sterile filtered water was available at all time

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50-70
- Photoperiod: Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and shaved

Vehicle:

other: polyethylene glucol

Controls:

other: untreated skin of the same animals

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 10 g of the test item was mixed with 20 mL of 50% solution polyethylene glycol and water to make a solution of 20 mL

Duration of treatment / exposure:

24 hours

Observation period:

6 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Application side: back
- % coverage: at least 10% of the total body surface
- Type of wrap if used: aluminium foil secured with "sleek" adhersive tape. The test sides were than enclosed by a 6 wide Coban self adhesive bandage the edges of which were fixed to the skin by stripes.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h - 72h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h - 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24h - 72h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24h - 72h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Results 5

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24h - 72h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Results 6

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: 24h - 72h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Results 7

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: 24h - 72h

Score:

0

Max. score:

4

Remarks on result:

other: intact skin

Results 8

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: 24h - 72h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: intact skin

Irritant / corrosive response data:

The test substance ist not irritating to intact skin within 72 hours.

Any other information on results incl. tables

Table 1: Erythema formation

Erythema Formation
	Intact		Abraded		Total
No	24h	72h	24h	72h
11	0	0	1	0
13	0	0	1	0
15	0	0	1	0
12	0	0	1	0
14	0	0	1	0
16	0	0	1	0
Mean	0.00	0.00	1.00	0.00	1.00

 

Table 2: Oedema formation

Oedema Formation
	Intact		Abraded		Total
No	24h	72h	24h	72h
11	0	0	2	0
13	1	0	2	0
15	1	0	2	1
12	0	0	2	0
14	0	0	2	0
16	2	0	3	1
Mean	0.67	0.00	2.17	0.33	3.17

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Because of the findings regarding the intact skin, the test substance is not considered irritating to the skin.

Executive summary:

Groups of six New Zealand White rabbits (4 females, 2 males) were dermally exposed to the test item. Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used. Immediately before the application of the test compound, the right hand site was abraded, the left hand site remained intact. 10 g of the test item was mixed with 20 mL of a 50% solution of polyethylene glycol and water to make a solution of 20 mL. 1.5 mL was applied to each test site on a 2.5 cm gauze pad. The test sites were covered with an occlusive dressing for 24 hours. No erythema effect was observed on the intact skin sites after application of the test compound. On the abraded sites 6/6 animals showed a slight erythema effect, which was fully reversible within 72 hours. Slight to moderate edema was seen on 3/6 intact sites and 6/6 abraded sites, 24 hours after application of the compound. Verly slight edema was still present on 2/6 abraded sites at 72 hours, but had returned to normal by day 6. The observed edema effect to the intact skin was also fully reversible within 72 hours. The observed mean edema and erythema score for the intact skin were 0.33 and 0, repectively.