7-({[3-({4-[(2-hydroxy-1-naphthyl)diazenyl]phenyl}diazenyl)phenyl]sulfonyl}amino)naphthalene-1,3-disulfonic acid, lithium sodium salts

Endpoint summary

Description of key information

Eye irritation       

CJ321was notirritantto the eye(OECD TG405).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2015

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliable review of similar substances. Further animal testing cannot be justified

Justification for type of information:

Assessment based on structural activity and grouping with similar substances.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Considered non-irritating based on review of animal testing on this group of substances.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions of similar structures, for the test substance the skin irritation is considered non-irritating.
No further animal testing canbe justified.

Executive summary:

As withall dyes, the intense colour can mask effects on the skin and good studies will have included local histology assessment of skin to see if microscopic damage at cellular level. This was not apparent in the data reviewed, but there is no indication of adverse effects from in-vivo skin irritation studies.

 

Most studies reviewed appeared to follow the principles of OECD 404, with some 3-rabbit EU studies and 6-rabbit US studies. Scoring methods reported were typically based on Draize, but some reported individual scores, some reported mean scores and some reported totals; this made interpretation difficult as methods were not always clear. However, conclusions are consistently negative.

 

No references have been found with regard to in-vitro assessments.

 

Historical use has not indicated any local irritation to skin to workers or users and there is a high level of confidence that there is no local skin irritation. However, in view of potential sensitising effects, care is needed to avoid repeated skin exposure to concentrated material. 

 

Data reviewed has been predominantly based on rabbit testing, but data on rat (acute dermal toxicity) and guinea pigs (non-maximised methods as well as challenge phases of maximised studies) shows a good level of local tolerance

 

No further animal testing can be justified.

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 December 23, 2016 to April 13, 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: the animal health research institute, council of agriculture, executive yuan
- Age: approximately 2-3 months
- Weight at study initiation: 2035-2278 g
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12-hrs dark / 12-hrs light

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 0.1 g

Observation period (in vivo):

1, 24, 48, 72 hours

Number of animals or in vitro replicates:

Three

Irritation parameter:

cornea opacity score

Basis:

animal: #10, #11 and #12

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal: #10, #11 and #12

Time point:

24/48/72 h

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal: #10, #11 and #12

Time point:

24/48/72 h

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal: #10, #11 and #12

Time point:

24/48/72 h

Max. score:

0.66

Reversibility:

fully reversible within: 48 hours

Remarks on result:

positive indication of irritation

Table 1. Individual Body Weights and Clinical Observations

Animal ID	Body weight (g)		Body weight change (g) (D4-D1)	Clinical observation between D1 and D4
	D1	D4
10	2035	2224	189	Normal
11	2278	2324	46	Normal
12	2168	2312	144	Normal

Table 2. Eye Irritation Scores at Observation Point on Treated Eye

Animal I.D.	Observation point	Cornea (D/A^3)^1	Iris	Conjunctivae (R/D)^2
10	1 h^4	1/3	0	3/2
	24 h	0/-	0	2/2
	48 h	0/-	0	0/0
	72 h	0/-	0	0/0
11	1 h^4	1/3	0	2/2
	24 h	0/-	0	2/2
	48 h	0/-	0	1/0
	72 h	0/-	0	0/0
12	1 h^4	1/3	0	2/2
	24 h	0/-	0	2/2
	48 h	0/-	0	1/0
	72 h	0/-	0	0/0

¹ (D/A) = (Degree of density/Area of opacity)                                                                

² (R/D) = (Redness/Chemosis)

³ Areaof corneal opacity involved : 1 = less than one-quarter; 2 = graeter than one-quarter but less than half; 3 = greater than half but less than three-quarter; 4 = greater than three-quarter, up to whole area

⁴ Eye rinsed with saline at this time point

-: Not available

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CJ321 showed that positive irritant to the eye. Therefore, CJ321 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316007-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012).CJ321 was given by a single ocular application at 0.1 g amount toNZW female rabbits and followed by ocular examination and clinical observation for 4 days. There were no test article effects on body weight. Reversible corneal opacity, conjunctivalredness, or chemosiswas observed within 72 hours after test article application.On the basis of the test results given above, the response of the test article was judged as a positive irritant to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

As withall dyes, the intense colour can mask effects on the skin and good studies will have included local histology assessment of skin to see if microscopic damage at cellular level. This was not apparent in the data reviewed, but there is no indication of adverse effects from in-vivo skin irritation studies.

 

Most studies reviewed appeared to follow the principles of OECD 404, with some 3-rabbit EU studies and 6-rabbit US studies. Scoring methods reported were typically based on Draize, but some reported individual scores, some reported mean scores and some reported totals; this made interpretation difficult as methods were not always clear. However, conclusions are consistently negative.

 

No references have been found with regard to in-vitro assessments.

 

Historical use has not indicated any local irritation to skin to workers or users and there is a high level of confidence that there is no local skin irritation. However, in view of potential sensitising effects, care is needed to avoid repeated skin exposure to concentrated material. 

 

Data reviewed has been predominantly based on rabbit testing, but data on rat (acute dermal toxicity) and guinea pigs (non-maximised methods as well as challenge phases of maximised studies) shows a good level of local tolerance

 

No further animal testing can be justified.

 

Eye irritation

CJ321 was given by a single ocular application at 0.1 g amount to NZW female rabbits and followed by ocular examination and clinical observation for 4 days. There were no test article effects on body weight. Reversible corneal opacity, conjunctivalredness, or chemosiswas observed within 72 hours after test article application.On the basis of the test results given above, the response of the test article was judged as a positive irritant to the eye.

Justification for selection of skin irritation / corrosion endpoint:

Reliable review of similar substances.

Further animal testing cannot be justified