Reaction products of 2,4-diaminobenzensulfonic acid and 2,3-dibromopropanoyl chloride, diazotised, subsequently coupled with 4-amino-5-hydroxynaphthalene-2,7-disulfonic acid, reacted with reaction products of 2,4,6-trichloro-1,3,5-triazine and N-ethylaniline, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Test substance is equal to one component of the UVCB substance under registration and it only slightly differs from the other main identified components. Details on the read-across are available in section 13. Source study has reliability 1.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reactive Red 272 - ELINCS

IUPAC Name:

Reactive Red 272 - ELINCS

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy Ltd., Animal production, 4332 Stein / Switzerland
- Weight at study initiation: 184-243 g
- Fasting period before study: overnight
- Housing: 5 animals per cage, segregated by sex in Macrolon cages type 4, with standard soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Volume applied: 10 ml/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days.
Signs and symptoms: daily for 14 days.
Body weight: immediately before administration and on days 7 and 14.
- Necropsies:gross necropsy at the end of the observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. Additionally, respiratory sounds were recorded in one male. The animals recovered within 3 days.

Body weight:

Not specifically addressed.

Gross pathology:

No deviations from normal morphology were found in all animals.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50 was determined to be greater than 2000 mg/kg bw.

Executive summary:

Method

In a oral toxicity study, performed according to OECD guideline 401, Tif: RAI f (SPF) rats (5/sex) were administered the test substance (2000 mg/kg bw) by oral gavage followed by a 14-day observation period.

Results

Mortality did not occur. Piloerection, hunched posture and dyspnea were seen. In one animal respiratory sound were recorded. However, all animals recovered in 3 days. Furthermore, necropsy did not reveal any significant abnormality. Based on these observations, the acute oral toxicity of test substance in rats of both sexes observed for a period of 14 days was greater than 2000 mg/kg bw.