2,7-Naphthalenedisulfonic acid, 4-amino-3,6-bis[2-[4-(ethenylsulfonyl)phenyl]diazenyl]-5-hydroxy-, sodium salt (1:2)

Endpoint summary

Description of key information

Taking data from skin and eye irritation/corrosion and the inhalative sensitisation studies into account, it can be concluded that the test substance is non-irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

10. Nov. to 13. Nov 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: single
- Diet (ad libitum): Altromin 2123
- Water (ad libitum): deionized chlorated water from automated supply
- Acclimation period: NA


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 10. Nov To: 13. Nov. 1987

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm²
- Type of wrap if used: semiocclusive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 hours

EVALUATION TIME
30-60 minutes, 24, 48, 72 hours after removal of bandage

SCORING SYSTEM: according to test guideline

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 30 to 60 min, 24, 48, 72 hours

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 30 to 60 min, 24, 48, 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

no signs of irritation observed

Other effects:

light blue staining of test site

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

not irritating
no labelling necessary

Executive summary:

Testing of Remazol Schwarz B 50 flüssig for skin irritation in rabbots according to OECD TG 404 did not lead to any signs of dermal irritation. The test item has not to be classified as skin irritant.

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:

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

Adequacy of study:

key study

Study period:

17 to 20 March 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without GLP; the tested substance is a precursor or Reactive Black 5 Bis-Vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form

Qualifier:

according to guideline

Guideline:

other: Federal Register 38, No 187

Principles of method if other than guideline:

Federal Register 38, No 187

GLP compliance:

no

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 1.6 to 2.1 kg
- Housing: single
- Diet (e.g. ad libitum): Standard food ERKA 8300
- Water (e.g. ad libitum): tap water
- Acclimation period: NA


IN-LIFE DATES: From: 17. March To: 20. March 1980

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg pasted with 1 drop physiological saline solution

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

The test item was applied to the left eye of each rabbit. The contra-lateral eye surved as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 7 hours

Score:

11

Max. score:

110

Reversibility:

not fully reversible within: 72 hours

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 1 hour

Score:

10

Max. score:

110

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 24 hours

Score:

5

Max. score:

110

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 48 hours

Score:

2

Max. score:

110

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 72 hours

Score:

1

Max. score:

110

Other effects:

no effects

 

Classification Index

0-10       non irritating

11-25     slightly irritating

26-56     moderately irritating

57-110   severely irritating

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification according to EC: not irritating
slightly irritating according to Federal Register 38, No 187

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation:

A GLP compliant acute dermal skin irritation/corrosion study in rabbits was performed with Reactive Black 5 in its bis-ester form according to OECD guideline 404. 3 rabbits were treated on shaved skin with the test substance for 4 h and observation up to 72 h. No signs of irritation observed other than light blue staining of test site. The mean oedema and erythema score noted was 0.

A study similar to OECD guideline 404 performed with 6 rabbits, over all mean irritation score noted was 3 wherein the reactions were not fully reversible within 72 h. Primary irritation index score was 2.96. According to the results of this study the test substance is slightly irritating according to Federal Register 38, No 187. No labelling required according to EU guideline. It can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment. Hence, can be concluded as not irritating to rabbit skin.

In a Barail-Test intracutaneous injection of 0.02 ml of an aqueous solution with 0.01 %, 0.1 %, 1 %, 10 % Reactive Black 5 concentration or physiological saline (control) were given to 3 rabbits. In addition, cutaneous administration of 0.5 ml of the 10 % preparation was applied to depilated flank skin of another 3 animals. The animals were observed up to 4 days. No irritation and other effects were observed. The overall mean irritation score was noted to be 0. Hence, test substance is determined as not irritating to rabbit skin.

Two other studies performed in the 1960ies and 1970ies reported the test substance as not irritating to rabbit skin.

Taking into consideration the results from the key study and other supporting studies, the test substance can be considered to be not irritating to rabbit skin.

Eye Irritation:

Two acute eye irritation/corrosion studies were performed following procedure mentioned in Federal Register 38, No.178. Six rabbits were treated with the test substance for 24 h and observation up to 72 h. Maximum mean total score (MMTS) after 72 h was observed to be 0 and 1 on a scale of 110 respectively. Based on the score, the test substance is determined to be not irritation to eye.

Taking the results from the above mentioned studies into consideration, the test substance can be determined to be not irritating to rabbit eye.

Respiratory irritation: No irritating effect was seen in the inhalative sensitization study in rats

Justification for classification or non-classification

Based on the finding in the skin and eye irritation studies, the test substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.