Reaction mass of sodium(E)-6,7'-carbonylbis(azanediyl)bis(4-hydroxy-3-((E)-phenyldiazenyl) naphthalene-2-sulfonate) and disodium 3-[(4-acetamidophenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]amino]carbonyl]amino]naphthalene-2-sulphonate and disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]

Endpoint summary

Description of key information

Non skin irritating

Non irritating to eye

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

Study period:

From 6 to 9 march 2007

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:

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

Remarks:

This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

Single 4 hours application

Observation period:

1, 24, 48 and 72 hours after administration

Number of animals:

3

Details on study design:

SCORING SYSTEM:
Primary irritation index / classification
- 0: non-irritant
- >0-2: mild irritant
- >2-5: moderate irritant
- >5-8: severe irritant

Irritation parameter:

erythema score

Basis:

other: 65954 male

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

other: 65956 male

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

erythema score

Basis:

other: 65957 male

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

edema score

Basis:

other: 65954 male

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

edema score

Basis:

other: 65956 male

Time point:

24/48/72 h

Score:

ca. 0

Irritation parameter:

edema score

Basis:

other: 65957 male

Time point:

24/48/72 h

Score:

ca. 0

Irritant / corrosive response data:

Primary irritation index: 0.0
No evidence of skin irritation was noted. Red-coloured staining was noted at two treated skin sites one hour after patch removal.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.

Executive summary:

A study was performed to assess the initation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.10). The method followed OECD Guidelines for Testing of Chemicals (24 April2002) No. 404 "Acute Dermal Initation/Corrosion" and Method B4 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 671548/EEC). The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.

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

Study period:

From 12 to 26 march 2007

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:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Remarks:

This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Species:

rabbit

Strain:

New Zealand White

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: single application of 0.1 ml (76.6 mg)

Duration of treatment / exposure:

Single application

Observation period (in vivo):

1, 24, 48 amd 72 hours and 7 days after administration

Number of animals or in vitro replicates:

3

Irritation parameter:

maximum mean total score (MMTS)

Basis:

animal: All rabbits (65967, 66032 and 66033 males)

Time point:

24/48/72 h

Score:

ca. 10

Reversibility:

fully reversible

Irritation parameter:

maximum mean total score (MMTS)

Basis:

other: all animals

Time point:

7 d

Score:

10

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test material produced moderate conjunctival irritation.
Dark red-coloured staining of the lower conjunctival and nictitating membranes and red-coloured staining of the fur around the treated eye were also noted. One treated eye appeared normal at the 72-hour observation and the two remaining treated eyes appeared normal atthe 7-day observation

Interpretation of results:

GHS criteria not met

Conclusions:

Classification: MILD IRRITANT (CLASS 4 ON A 1-8 SCALE)
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.

Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.09), The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 405 "Acute Eye Initation/Corrosion" and Method B5 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 67/548/EEC).

Classification: MILD IRRITANT (CLASS 4 ON A 1-8 SCALE). The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation/corrosion

Three studies on four are according to identify Direct Red 23 (DR23) as skin not irritating; Clariant 2002 study has been performed with DR23 at 87.5% and Clariant 2007 with DR23 at 70%.

The studies on structural analogues Direct Red 239 and Direct Red 262 confirm the not irritability for skin of DR23 .

 

Eye irritation

It was noted that test material produced moderate conjunctival irritation, reported in Clariant 2007 report. It is possible that the DR23 could be irritating to eye in some conditions, expecially if in powder form; however the eventually disadvantages can be easy obviated by correctly using of the substance with the necessary preautions.

In any case none of those effects are enough to classify the substance as irritant, according to CLP regulation (EC1272/2008).

 

Respiratory irritation

Tests on this pourpose have not been conducted; nevertheless DR23 is not expected to be a respitatory irritant.

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 theCorrosive category 1:

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

Subcategory 1Bwhere 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.

The substance is not classified as skin irritant because in the performed studies, the tested similar substances don't meet the classification criteria of the CLP regulation n. 1272/2008.

 

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.

The substance is not classified as eye irritant because in the performed studies, the tested similar substances don't meet the classification criteria of the CLP regulation n. 1272/2008.

According to CLP regulation (EC1272/2008) Direct Red 23 is not classified as skin/eye/respiratory irritant.