Reaction mass of Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)] [N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]]-, lithium sodium and Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)][N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]acetamidato(2-)]-, lithium sodium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

non-GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500.41

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-, lithium sodium

EC Number:

288-603-7

EC Name:

Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-, lithium sodium

Cas Number:

85828-76-8

Molecular formula:

C36H19CrLiN6NaO11S

IUPAC Name:

lithium sodium [3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-)

Constituent 2

Reference substance name:

Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)][N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]acetamidato(2-)]-, lithium sodium

EC Number:

288-602-1

EC Name:

Chromate(2-), [3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)][N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]acetamidato(2-)]-, lithium sodium

Cas Number:

85828-75-7

Molecular formula:

C38H22CrLiN7NaO12S

IUPAC Name:

lithium sodium [3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)][N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthyl]acetamidato(2-)]chromate(2-)

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

NZW Albino Rabbits
Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal
Food: mümmel Z ad libitum
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water ad libitum
Single housing
Weight: mean 2.6 kg

ENVIRONMENTAL CONDITIONS
- Temperature: 16-18°C
- Humidity: approx. 40 %
- Lighting time: 12 hours daily

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

right flank additionally scarified

Vehicle:

other: pasted with water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24 hours

Observation period:

8 days

Number of animals:

6

Details on study design:

TEST SITE
- Preparation: about 24h before the start of the study the skin on the flanks of 6 rabbits was depilated on both sides of the body on an area of approximately 8 x 8 cm using electric
clippers. The skin on the right flank at the test patch application site was additionally scarified using a scarifier.
- Area of exposure: 2.5 x 2.5 cm, covered with medical gauze and indifferent, impermeable PVC foils (5 x 5 cm)
- Type of wrap if used: Eloflex as elastic bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours


SCORING SYSTEM: according to the score of Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 72 hours, 8 days

Score:

0

Max. score:

4

Remarks on result:

not determinable

Remarks:

discolouration of skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 hours

Score:

0.25

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Remarks:

clipped skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

no indication of irritation

Remarks:

scarified skin

Irritant / corrosive response data:

No signs of systemic toxicity were observed during the observation period

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the experimental conditions the test item is detemined to be not irritating to the skin.

Executive summary:

In the primary skin irritation test according to the Code of Federal Regulations, Title 16, Section 1500.41 the test item produced a primary irritation score of about 0.3. Due to substance-related coloration of the skin slight erythema could not be detected if apparent. Thus, the product is assassed to be non-irritant to the skin.