2-[4-[[2-(cyanoimino)hexahydro-4,6-dioxo-5-pyrimidyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)

Endpoint summary

Description of key information

Acute oral toxicity:

The LD50 of the test substance was found to be greater 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: summary of study results, limited documentation, sufficient for assessment with restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

only three animals of the same sex used

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Lot/batch No.: Op.604/89

Species:

rat

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adult animals

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Piloerection, hunched posture, and dyspnea were observed. All animals recovered within 5 days.

Gross pathology:

At autopsy, a spotted thymus was found in one female.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

sufficient for assessment with restrictions (limited documentation of the key study)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity:

Key stuy

The test material was administered by gavage to 3 male and 3 female rats in a single dose of 2000 mg/kg bw similar to OECD 401. No mortalities occurred. The animals showed piloerection, hunched posture and dyspnea within 5 days after administration but were free of symptoms afterwards. At autopsy, a spotted thymus was found in one female. Based on these findings, the LD50 was determined to be greater than 2000 mg/kg bw in both male and female rats.

Supporting study no. 1

In another acute oral toxicity study according to Guideline 401, the test material (as a composition containing 10 % active substance was administered by gavage to 10 rats (5 male and 5 female rats). A single dose of 5000 mg/kg bw was applied, using water as vehicle, in a dose volume of 10 mL/kg bw. The test animals were observed for a period of 14 days. From day 1 until day 10 the test animals exhibited dyspnea. Until day 11 ruffled fur was observed. Until day 5 the animals exhibited a curved body position. No mortality occurred. Based on this result, the LD50 value was determined to be greater than 5000 mg/kg bw.

The calculated LD50 for a test substance preparation of 80% was determined to be 625 mg/kg bw.

Supporting study no. 2

In a third acute oral toxicity study the test item (of unknown composition) was administered to 10 rats (5 male and 5 female) by gavage. After administration of the compound, the animals were observed for 14 days. No deaths occurred. Light brown staining of the urine and faeces was seen in all of the animals at 23 hours only. No abnormalities were seen at terminal autopsy on day 14. As a result, the LD50 was determined to be greater than 10 mL/kg. As the composition of the test substance was unknown, the study results were not used for the assessment of the LD50 value.

Acute inhalation toxicity

The study does not need to be conducted as the exposure route via inhalation is unlikely taking into account that no vapour pressure can be determined, as the melting point of the test substance is > 300°C.

Acute dermal toxicity

The substance does not meet the criteria for classification as acutely toxic or STOT SE by the oral route, and no systemic adverse effects have been observed in an in vivo skin sensitisation study with dermal exposure or in the in vivo skin irriation study. Therefore the acute dermal toxicity study is not required.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The oral LD50 of the test substance was found to be greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.