Trisodium 5-[[4-chloro-6-[(o-tolyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Endpoint summary

Description of key information

Oral

The acute oral LD50 of the test material was determined to be > 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-Nov-18

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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:

no

Remarks:

Testing was performed outside the EU to meet non-EU regulatory requirements

Test type:

standard acute method

Limit test:

yes

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

Remarks:

Criteria used for interpretation of results: EU

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 the substance 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 the substance (Specimen no. 90077902). 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 the substance 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

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
Based on Column 2 of the table given in REACH Annex VIII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets.
Since the melting point of the substance is above 300 °C, the vapour pressure of the substance is considered to be very low. Furthermore, the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate. The inhalation route of exposure is therefore considered to be unlikely and hence it is considered justified to omit an acute inhalation toxicity study.

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
In accordance with column 2 of REACH Annex VIII, an acute dermal toxicity study does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).
Two available acute oral toxicity studies with the substance provide LD50 values of greater than 2000 mg/kg bw. Hence the substance is not classified as hazardous by the oral route. Additionally, no effects were noted in the key in vivo skin irritation or skin sensitisation studies.
It is therefore considered justified to omit the acute dermal toxicity study.

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral

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 the substance was more than 2,000 mg/kg bw under the condition designed for this study.

Inhalation

Based on Column 2 of the table given in REACH Annex VIII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets.

Since the melting point of the substance is above 300 °C, the vapour pressure of the substance is considered to be very low. Furthermore, the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate. The inhalation route of exposure is therefore considered to be unlikely and hence it is considered justified to omit an acute inhalation toxicity study.

Dermal

In accordance with column 2 of REACH Annex VIII, an acute dermal toxicity study does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).

Two available acute oral toxicity studies with the substance provide LD50 values of greater than 2000 mg/kg bw. Hence the substance is not classified as hazardous by the oral route. Additionally, no effects were noted in the key in vivo skin irritation or skin sensitisation studies.

It is therefore considered justified to omit the acute dermal toxicity study.

Justification for classification or non-classification

The acute oral toxicity of the substance shows LD50 of greater than 2000 mg/kg bw.

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity via the oral route.