Registration Dossier

Administrative data

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:
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:
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/-

03

0/0

48 h

0/-

03

1/0

72 h

0/-

03

1/0

D7

0/-

03

0/0

D14

-

-3

-

D21

-

Normal

-

05

1 h

0/-

0

2/1

24 h

0/-

03

0/0

48 h

0/-

03

0/0

72 h

0/-

03

0/0

D7

-

-3

-

D14

-

-3

-

D21

-

Normal

-

06

1 h

0/-

0

2/1

24 h

0/-

03

2/3

48 h

0/-

03

1/0

72 h

0/-

03

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.

Justification for classification or non-classification