5-({4-chloro-6-[(2-methylphenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfophenyl)diazenyl]naphthalene-2,7-disulfonic acid, lithium sodium salts

Endpoint summary

Description of key information

Acute toxicity: via oral route

The LD50 of CJ307 is higher than 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2009-Dec-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The structure of the read-across substance, EC:300-504-3, is the same as the test substance. Therefore, the human toxicity and environmental toxicity is the same. The only difference is the test substance containing lithium. However, the low level of lithium will not change the classification.

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Evercion SR61, Reactive red 3-1, EC: 300-504-3

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 male and 5 female Sprague-Dawley rats about 5 weeks old were obtained from the supplier. The rat quarantined for 2 weeks and acclimated to the condition of the animal room for at least 5 days prior to the test.

Environmental conditions:
Temperature: 22±4°C
Relative humidity: 40-70%
Light cycle: 12 hours light/dark

Route of administration:

oral: gavage

Vehicle:

water

Doses:

2000 mg/ kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

Limit test: The test article was administered to the rats by oral gavage with gastric tube at a dose of 2,000 mg/kg bw. Individual body weight of the treated rats was measured on day 1, day 8 and day 15.
After dosing of the test article, all treated rats were observed individually 2 a day by veterinarian for a total of 14 days.
During the observation period, the mortality of the rats, toxic reaction after dosing, time of onset and length of period were recorded. Any found dead or moribund rats in the interim would be examined by gross necropsy.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

All the treated rats survived till the end of the study.

All the survival rats were subjected to gross necropsy examination on day 15. Results indicated that there were no significant gross lesions founded.

Interpretation of results:

GHS criteria not met

Conclusions:

After application of the test article, all treated rats survived till the end of the study. The body weight of the rats was increased normally during the observation period and the result of the gross necropsy examination showed that there were no significant gross lesions founded.
According to the above findings, the median lethal dose (LD50) of “EVERCION RED P-4BN” was greater than 2,000 mg/kg under the condition designed for this study.

Executive summary:

This study was conducted to investigate the acute oral toxicity of “EVERCION RED P-4BN (Specimen no. 90077902, Reactive Red 3-1).” 5 males and 5 females Sprague-Dawley rats in the study were housed in Yang-Ming University Laboratory Animal Quarters. The test article was administered to the rats by oral gavage at a dose of 2,000 mg/kg bw. After application of the test article, the rats were observed for mortality and sign of toxicity for 14 days. Results showed all treated rats survived till the end of the study. The body weight of the rats was increased normally during the observation period. At the end of the study, all treated rats were subjected to gross necropsy, and the examination showed that there were no significant gross lesions founded.

According to the findings of the study, the median lethal dose (LD50) of “EVERCION RED P-4BN” was more than 2,000 mg/kg bw under the condition designed for this study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Methods not always explicit in reviews, but OECD testing principles appear to have been followed in most cases.

GLP compliance:

not specified

Test type:

other: Review of various studies

Limit test:

no

Species:

rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mostly rat data, but dermal effects on guinea pigs and rabbits also examined (non-maximised sensitisation studies and dermal irritation)

Type of coverage:

not specified

Vehicle:

not specified

Doses:

Up to 2000 mg/kg

Control animals:

not specified

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality reported

Clinical signs:

other: Other than discolouration, no clinical signs

Gross pathology:

No adverse systemic effects reported.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on reliable review of literature and assessment of similar sulphonated azo dyes.
No further animal testing is justified.

Executive summary:

From assessment of similar sulphonated azo dyes, none are noted as being acutely toxic and there is no evidence of dermal absorption. From various data sources, it is considered unlikely that the substance will be acutely toxic by the dermal route. Most azo dyes have acute toxicity discriminating dose > 2000 mg/kg and the similar substances reviewed fall into this category.

 

The impact of lithium is not likely to impact on the toxicity when comparing with sodium salts as dermal toxicity of lithium substances are reported to be low and in view of the minimal % w/w content of lithium, this is not significant in the classification of toxicity.

 

Studies on guinea pigs and rabbits for sensitising and irritancy assessment have not revealed any evidence of adverse systemic effects. Only the maximised sensitising studies (ie injected) appear to give positive results with some azo dyes, confirming low levels of dermal absorption. Discolouration of skin will occur and the colour is difficult to wash off.

 

It is not considered justifiable to perform dermal toxicity testing on CJ307 in view of the similarity with other dyes assessed. It should also be noted that some other registrations have indicated waivers for this endpoint.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

Acute toxicity: via oral route

LD 50 of CJ307 is read-across from Evercion Red P-4BN due to the similar structure. The result is higher than 2000 mg/kg bw.

5 males and 5 females Sprague-Dawley rats in the study were housed in Yang-Ming University Laboratory Animal Quarters. The test article was administered to the rats by oral gavage at a dose of 2,000 mg/kg bw. After application of the test article, the rats were observed for mortality and sign of toxicity for 14 days. Results showed all treated rats survived till the end of the study. The body weight of the rats was increased normally during the observation period. At the end of the study, all treated rats were subjected to gross necropsy, and the examination showed that there were no significant gross lesions founded.

According to the findings of the study, the median lethal dose (LD50) of “EVERCION RED P-4BN” was more than 2,000 mg/kg bw under the condition designed for this study.

Acute toxicity: via dermal route

Based on reliable review of literature and assessment of similar sulphonated azo dyes.

LD 50 of CJ307 is higer than 2000 mg/kg bw.