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

Endpoint summary

Description of key information

Acute Toxicity/Oral LD50=6,16 g/kg

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:

November 1989-February 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards and acceptable for assessment

Qualifier:

no guideline available

Principles of method if other than guideline:

The test was carried out in 1990. The test meets National standards method with acceptable restrictions.

GLP compliance:

no

Test type:

other: unknown

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Test animals:
Age and weight at the study initiation: weight -137-160 g

Route of administration:

oral: unspecified

Vehicle:

other: 20% aqua solution

Doses:

3.981 g/kg, 5.020 g/kg, 6.310 g/kg, 7.943 g/kg

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy finding

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

6.16 other: g/kg

Based on:

not specified

95% CL:

> 5.637 - < 6.732

Mortality:

Death occurred till 3 hours after application.
Number of deaths of each level:
3.981 g/kg: 0
5.020 g/kg: 2
6.310 g/kg: 4
7.943 g/kg: 10

Clinical signs:

diarrhea in animals of all dose levels, in 2 hours till 2nd day- languor in all dose levels except the dose level 3.981 g/kg. From the 3rd day – without clinical signs of intoxication

Gross pathology:

Necropsy finding: colouration of organism in dead animals; in survivor animals – coloured liver and kidneys

Interpretation of results:

GHS criteria not met

Conclusions:

Based on determined value LD50 = 6.16 g/kg, the tested substance, Reactive Red 45:1, has not been classified as acute toxic by the oral route.

Executive summary:

Based on determined value LD50 = 6.16 g/kg, the tested substance, Reactive Red 45:1, has not been classified as acute toxic by the oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 160 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. Referring to the very low vapour pressure of the substance, the fact that the substance is imported into the EU as a dust-free powder or as a granulate, the inhalation route of exposure is considered to be unlikely,
thus the study on acute inhalation toxicity is being waived.

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 physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

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)

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the results of the Acute oral toxicity study, the tested substance, Reactive Red 45:1, has not been classified as acute toxic by the oral route.