2-{[4-chloro-6-({8-hydroxy-3,6-disulfo-7-[(1-sulfo-2-naphthyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfobenzoic acid, lithium sodium salts

Endpoint summary

Description of key information

Eye irritation       

CJ308 was not irritant to 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:

2016

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:

other: Assessment

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: Not considered to be irritating to skin

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

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

As with all 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: 2181-2207 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 and 7, 14, 21 Days

Number of animals or in vitro replicates:

Three

Irritation parameter:

cornea opacity score

Basis:

animal: #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal: #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal: #4, #5 and #6

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: Day7

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal: #4, #5 and #6

Time point:

24/48/72 h

Score:

1

Max. score:

3

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 D21
	D1	D4
04	2194	2272	78	Normal
05	2207	2245	38	Normal
06	2181	2260	79	Normal

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

Animal I.D.	Observation point	Cornea (D/A)^1	Iris	Conjunctivae (R/D)^2
04	1 h	0/-	0	2/1
	24 h	0/-	0^3	0/0
	48 h	0/-	0^3	1/0
	72 h	0/-	0^3	1/0
	D7	0/-	0^3	0/0
	D14	-	-^3	-
	D21	-	Normal	-
05	1 h	0/-	0	2/1
	24 h	0/-	0^3	0/0
	48 h	0/-	0^3	0/0
	72 h	0/-	0^3	0/0
	D7	-	-^3	-
	D14	-	-^3	-
	D21	-	Normal	-
06	1 h	0/-	0	2/1
	24 h	0/-	0^3	2/3
	48 h	0/-	0^3	1/0
	72 h	0/-	0^3	0/0
	D7	-	-^3	-
	D14	-	-^3	-
	D21	-	-^3	-

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

² (R/D) = (Redness/Chemosis)

³ Deep pink colored iris

-: Not available

Interpretation of results:

GHS criteria not met

Conclusions:

According to OECD 405 test method, CJ308 showed that positive irritant to the eye. Therefore, CJ308 was not met a category based on GHS criteria.

Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316005-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012). CJ308 was given by a single ocular application at 0.1 g amount to NZW female rabbits and followed by ocular examination and clinical observation no more than 21 days. There were no test article effects on body weight. Reversible conjunctivalredness and chemosiswas observed within 7 days after test article application. On the basis of the test results given above, the response of the test article was judged as a light irritant to the eye.

However, the result has not met a category based on GHS criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation / corrosion

As with all 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

Most studies reviewed appeared to follow the principles of OECD methods with recognised scoring methods. Most studies were 3-rabbit EU studies, but also included some 6-rabbit US studies. There was inconsistency in scoring and in the results found for the different dyes; in some cases, low scores were assigned despite discolouration and in other cases, high scores were assigned despite lack of evidence of adverse effects.

 

No further animal testing can be justified. 

Justification for selection of skin irritation / corrosion endpoint:

Reliable review of similar substances.

Further animal testing cannot be justified

Eye irritation

CJ308 was given by a single ocular application at 0.1 g amount toNZW female rabbits and followed by ocular examination and clinical observation no more than 21 days. There were no test article effects on body weight. Reversible conjunctivalredness and chemosiswas observed within 7 days after test article application.On the basis of the test results given above, the response of the test article was judged as a light irritant to the eye.

However, the result has not met a category based on GHS criteria.