Trisodium 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,5-trisulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-10-24 to 1990-04-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24 February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,5-trisulphonate

EC Number:

274-349-4

EC Name:

Trisodium 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,5-trisulphonate

Cas Number:

70161-14-7

Molecular formula:

C20H16ClN9O10S3.3Na

IUPAC Name:

trisodium 7-({4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-(carbamoylamino)phenyl}diazenyl)naphthalene-1,3,5-trisulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Orange 12

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 8 weeks (mean), females: 10 weeks (mean)
- Weight at study initiation: Males: 180 g (mean), females 172 g (mean)
- Fasting period before study: 16 hours before and 4 hours after treatment
- Housing: Animals were kept in Makrolon cages type III on dust-free wood granules
- Diet (e.g. ad libitum): Altromin R 1324 from Altromin GmbH, Lage, Germany; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

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: weighing: immediately before application, weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

n.a.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No deaths

Clinical signs:

No effects observed

Body weight:

No effects observed. For individual results please refer to Table 1 in box "Any other information on results incl. tables"

Gross pathology:

No effects, except one finding in one male animal (elastic knot in the glandular gastric mucosa).

Any other information on results incl. tables

Table 1: Individual body weights

Males				Females
Animal No.	Week			Animal No.	Week
	0	1	2		0	1	2
1	170	212	237	6	167	178	184
2	188	231	266	7	175	186	199
3	176	207	227	8	176	193	201
4	188	231	260	9	170	179	203
5	178	221	242	10	172	192	196
Mean	180	220	246		172	186	197

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study, the LD50 of the test item was determined to be greater than 2000 mg/kg bw in rats.

Executive summary:

In an acute oral toxicity study, young adult Wistar rats (5/sex) were given a single oral dose of the test item at a dose of 2000 mg/kg bw and were observed for 14 days. All animals survived until the end of the study. No effects on body weight and no adverse signs of toxicity were observed. Gross pathology performed on animals revealed no adverse signs, except one finding in one male animal, which showed a elastic knot in the glandular gastric mucosa. Based on the results, the oral LD50 in both male and female rats can be considered to be greater than 2000 mg/kg bw. Based on these results, no classification for acute oral toxicity is warranted according to CLP criteria.