Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate

Endpoint summary

Description of key information

In an acute oral toxicity study equivalent or similar to OECD Guideline 401 (Acute oral toxicity) 5 male and 5 female rats were dosed with 2000 mg/kg Bayscript Yellow CA 51069 by gavage. Mortality, clinical signs and body weight were recorded for 14 days. No findings or symptoms appeared that could be attributed to the administration of BAYSCRIPT Yellow CA 51069. The discriminating dose for male and female rats was 2000 mg/kg body weight.

No acute inhalation or dermal toxicity studies are available.

According to Commission Regulation (EU) 2016/863 of May 2016, (point 8.5 of Annex VIII ) for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. Based on the physicochemical data (vapour pressure of the substance is  of 0 Pa at 25°C (calculated), water solubility of  71.33 g/L at 20 °C and pH 9.14 and the log Kow of  -2.87 at 20 °C and pH 6.80 testing by dermal route seems appropriate.

According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘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’.  The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.

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:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

5 male and 5 female rats were dosed with 2000 mg/kg Bayscript Yellow CA 51069 by gavage. Mortality, clinical signs and body weight were recorded for 14 days.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

At the start of the experiment, male rats were about 8 weeks of age and females about 9 weeks. The average initial weight of males was 184 g and of females 164 g. The mean deviation in animal weights was less than 20%. Females were nulliparous and non-pregnant.
Prior to study initiation the condition of the animals' health was checked. Only healthy animals without any clinical signs were included in the study. Animals were acclimated for at least 4 days before application. Five rats were used per dose and sex.

The rats were housed individually under conventional conditions in Makrolon® Type-III cages on low-dust wood granules, at a room temperature of 22 ± 2° C, with a 12-hour light/dark cycle (artificial lighting), relative humidity of about 50 ± 10% and approximately ten air changes per hour in groups of 5 animals.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The test substance was suspended under stirring on a magnetic stirrer in tap water at room temperature and intragastrically applied at a constant application volume of 10 ml/kg body weight. A rigid metal gavage was used for that purpose.

The test substance was formulated in the vehicle immediately before the start of the study. Because of the short time between preparation and application of the test substance analytical investigations on stability and homogeneity have not been performed.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female rats/dose

Control animals:

no

Details on study design:

The animals were inspected several times on the day of administration, and twice daily during the following 14-day observation period (once on weekends and bank holidays). During inspections, the type, onset, duration, and intensity of clinical signs were recorded and dead animals were removed if necessary. The date of death was recorded.

The animals were individually weighed directly before administration, after one week and at the end of the 14-day observation period. The application volume for each individual animal was based on its body weight just before application.

Gross pathological examinations were done on all animals sacrificed under deep diethyl ether anesthesia at the end of study. Necropsy records were prepared for all animals.

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the rats died.

Clinical signs:

other: No symptoms attributable to BAYSCRIPT Yellow CA 51069 occurred.

Gross pathology:

The animals sacrificed at the end of the study showed no gross pathological abnormalities.

No findings or symptoms appeared that could be attributed to the administration of BAYSCRIPT Yellow CA 51069. The LD50 values for male and female rats were greater than 2000 mg/kg body weight.

Interpretation of results:

GHS criteria not met

Conclusions:

A single oral dose of 2000 mg/kg bw caused no deaths. The LD50 is greater than 2000 mg/kg bw (discriminating dose).

Executive summary:

Acute toxicological investigations were conducted after oral administration of BAYSCRIPT Yellow CA 51069 to male and female Wistar rats.

The LD50 values for male and female rats were greater than 2000 mg/kg body weight.

No findings or symptoms appeared that could be attributed to the administration of BAYSCRIPT Yellow CA 51069.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP study equivalent or similar to OECD guidline 401.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In an acute oral toxicity study equivalent or similar to OECD Guideline 401 (Acute oral toxicity) the discriminating dose for male and female rats was 2000 mg/kg body weight.

According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘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’.  The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified for acute oral and dermal toxicity.