Sodium 4-[4-[[2-methyl-4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo]anilino]-3-nitrobenzenesulphonate

Endpoint summary

Description of key information

Not skin/eye irritating

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 November 28th to December 01st, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

The complete study report is not available, thus some details about test conditions are missing.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Controls:

yes, concurrent no treatment

Amount / concentration applied:

500 mg of the test material was administered to the intact skin.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

Three males

Details on study design:

SCORING SYSTEM
Skin reactions were recorded 1, 24, 48 and 72 hours after administration.
From Draize J H (1959) "Dermal toxicity" in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Assoc. of Food and Dug Officials of tne US, Austin, Texas p47

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Reversibility:

fully reversible within: 48 hrs

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Primary Irritation Index: 0.2, mild irritant

Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation.

Skin reaction	Observation time	Individual scores			Total
		Male	Male	Male
Erythema/Eschar	1	1	2	1	(4)
	24	0	1	0	1
	48	0	0	0	(0)
	72	0	0	0	0
	Mean 24, 48, 72 hrs	0.00	0.33	0.00	-
Oeadema	1	0	1	0	(1)
	24	0	0	0	1
	48	0	0	0	(0)
	72	0	0	0	0
	Mean 24, 48, 72 hrs	0.00	0.00	0.00	-

() Total values not used for calculation of primary initation index

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Not classified, according to the CLP Regulation (EC) No 1272/2008

Executive summary:

A study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit. The method followed OECD Guidelines 404 and Method B4 of Commission Directive 92/69/EEC. A single 4 -hour semi-occluded application (500 mg of the test material) was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48 and 72 hours after administration.

Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation.

Primary Irritation Index: 0.2, mild irritant

Conclusion

Mean values from grading at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.

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:

December from 04th to 13rd, 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

The complete study report is not available, thus some details about test conditions are missing.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Amount / concentration applied:

0.1 ml (93 mg) of the test material as administered to the non irrigated eye.

Duration of treatment / exposure:

4 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

Three rabbits

Details on study design:

SCORING SYSTEM
Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.

Irritation parameter:

cornea opacity score

Basis:

animal: 2/3

Time point:

24/48/72 h

Score:

< 1

Irritation parameter:

iris score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 1

Irritation parameter:

conjunctivae score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Irritation parameter:

chemosis score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2

Irritant / corrosive response data:

Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)

Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.

Individual and Mean Scores for Cornear lris and Conjunctivae for EU Labelling Regulations

	68 male			Mean 24/48/72 hrs	85 male			Mean 24/48/72 hrs	86 male			Mean 24/48/72 hrs
Time After Treatment	24 hrs	48 hrs	72 hrs		24 hrs	48 hrs	72 hrs		24 hrs	48 hrs	72 hrs
Degree of Comeal Opacity	0	0	0	0.00	2	2	1	1.67	0	0	0	0.00
Iridial Inflammation	0	0	0	0.00	1	1	0	0.67	0	0	0	0.00
Conjunctival Redness	1	0	0	0.33	2	2	1	1.67	1	1	0	0.67
Conjunctival Chemosis	0	0	0	0.00	2	2	0	1.33	0	0	0	0.00

Individual Scores for Ocular Irritation

	68 male				85 male					86 male
Time After Treatment	1hr	24 hrs	48 hrs	72 hrs	1hr	24 hrs	48 hrs	72 hrs	7 days	1hr	24 hrs	48 hrs	72 hrs
Degree of Comeal Opacity (E)	0	0	0	0	0S	2S	2	1	0	0S	0	0	0
Area of Corneal Opacity (F)	0	0	0	0	0	2	2	1	0	0	0	0	0
Score (ExF)x5	0	0	0	0	0	20	20	5	0	0	0	0	0
Iridial Inflammation (D)	0	0	0	0	0S	1S	1	0	0	0S	0	0	0
Score (Dx5)	0	0	0	0	5	5	5	0	0	0	0	0	0
Conjunctival Redness (A)	1S	1	0	0	1S	2S	2	1	0	1S	1	1	0
Conjunctival Chemosis (B)	0	0	0	0	1	2	2	1	0	0	0	0	0
Conjunctival Discharge (C)	1Sf	0Sf	0Sf	0Sf	2Sf	3Sf	2Sf	1Sf	0	1Sf	0Sf	0Sf	0Sf
Score (A+B+C)x2	4	2	0	0	8	14	12	6	0	4	2	2	0
Total Score	4	2	0	0	8	39	37	11	0	4	2	2	0

S = orange caloured staining

Sf = orange staining of the fur around the eye

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Not classified, according to the CLP Regulation (EC) 1272/2008

Executive summary:

A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405 and Method B5 of Commission Directive 92/69/EEC. A single application 0.1 ml (93 mg)of the test material was administered to the non irrigated eye of three rabbits. Ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration.

Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.

Maximum Group Mean Score: 14.3, mild irritant (class 4 on 1-8 scale)

Conclusion

The mean values from grading at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.

Therefore, the substance does not meet the criteria to be classified as eye irritating, according to the CLP Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SKIN IRRITATION

The key study was performed in New Zealand White rabbit, following the testing procedures outlined into the OECD Guidelines 404 and Method B4. Individual skin reactions included very slight to well-defined erythema and an isolated incident of very slight oedema. No evidence of skin irritation was noted at the 48-hour observation.

The results obtained are confirmed by the outcomes of the other three supporting studies available.

EYE IRRITATION

The key study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit. The method followed OECD Guidelines No. 405 and Method B5. A single application 0.1 ml (93 mg) of the test material was administered; ocular effects were recorded 1, 24, 48 and 72 hours and 7 days after administration. Individual reactions included orange coloured staining of the eye and fur surrounding the eye, translucent corneal opacity, iridial inflammation and minimal to moderate conjunctival irritation.

The mean values from grading at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.

The study outcomes and conclusion were confirmed by three additional supporting available studies.

Justification for classification or non-classification

According to the CLP Regulation (EC) No 1272/2008, 3.2 Skin corrosion/irritation section, skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.

In the key study, the mean values from grading at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.

According to the CLP Regulation (EC) No 1272/2008, serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance, which is not fully reversible within 21 days of application.

The mean values from grading at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in at least two of three tested animals.

In conclusion, the substance does not meet the criteria to be classified for the eye/skin irritation, according to the CLP Regulation (EC) No 1272/2008.