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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Single dose
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt
EC Number:
279-256-2
EC Name:
Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt
Cas Number:
79771-28-1
Molecular formula:
C52H38Cl2N16O24S6.6Na
IUPAC Name:
Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Everzol SB26
- Substance type: Powder
- Composition of test material, percentage of components: 78.12%
- Lot/batch No.: 3540
- Storage condition of test material: Ambient

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: BioLASCO Taiwan Co., Ltd.
- Age at study initiation: about 5 week old
- Fasting period before study: overnight
- Housing: in polycarbonate cage
- Water: ad libitum
- Temperature (°C): 20-25 °C
- Humidity (%): 40-70 %
- Photoperiod: 12-hrs dark / 12-hrs light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
For male: five
For female: five
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
other: No adverse effects

Any other information on results incl. tables

Table 1. Symptoms and time course of death of rats administered by gavage with Everzol Blue ED-G

Sex

Dose

(mg/kg)

Treated

No.

Symptom

No. Observed

Total No. of death

Hour

Day

1

2

4

1

2

3

4

5

6

7

14

Male

0

5

Normal

5

5

5

5

5

5

5

5

5

5

5

 

Death

0

0

0

0

0

0

0

0

0

0

0

0

5,000

5

Normal

5

5

5

5

5

5

5

5

5

5

5

 

Death

0

0

0

0

0

0

0

0

0

0

0

0

Female

0

5

Normal

5

5

5

5

5

5

5

5

5

5

5

 

Death

0

0

0

0

0

0

0

0

0

0

0

0

5,000

5

Normal

5

5

5

5

5

5

5

5

5

5

5

 

Death

0

0

0

0

0

0

0

0

0

0

0

0

Table 2. Mortality rate of rats administered by gavage with Everzol Blue ED-G

Dose

(mg/kg body weight)

Dead No./Treated No.

Mortality1)

(%)

Male

 Female

Total No.

Control

0/5

0/5

0/10

0

5,000

0/5

0/5

0/10

0

1) Mortality (%) = Dead No.÷Treated No. × 100%

Table 3. The body weight changes of rats administered by gavage with Everzol Blue ED-G on days 0, 7 and 14

Sex

Dose

(mg/kg body weight)

Body weight (g)1)

Day 0

Day 7

Day 14

Male

Control

181.5 ± 4.7

205.2 ± 11.5

229.9 ± 20.8

5,000

180.6 ± 4.2

219.1 ± 19.2

240.9 ± 31.3

Female

Control

159.3 ± 5.2

174.3 ± 4.5

198.4 ± 6.0

5,000

159.2 ± 3.2

187.3 ± 11.8

203.1 ± 18.5

1) Mean ± S.D., n=5. Means in each column followed by asterisk (*) indicate significant difference at ρ<0.05 level by Student’st-test.

 

Table 4. The body weight gains of rats administered by gavage with Everzol Blue ED-G on days 7 and 14

Sex

Dose

(mg/kg body weight)

Body weight gain (g)1)

Day 72)

Day 143)

Male

Control

23.6 ± 9.6

48.4 ± 18.7

5,000

38.5 ± 15.7

60.3 ± 28.2

Female

Control

15.1 ± 3.6

39.1 ± 7.0

5,000

28.1 ± 12.6

43.9 ± 20.0

1) Mean ± S.D., n=5. Means in each column followed by asterisk (*) indicate significant difference at ρ<0.05 level by Student’st-test.

2) Body weight (BW) gain on the 7thday = (7th-0th) BW (g).

3) Body weight (BW) gain on the 14thday = (14th-0th) BW (g).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to EPA OPPTS 870.1100 and OECD 401 test method, the LD50 of Everzol Blue ED-G was greater than 5000 mg/kg B.W.. Therefore, Everzol Blue ED-G is not classified according to CLP regulation.
Executive summary:

This test using the procedures outlined in the TACTRI for 0136Y07AORe which is based on the USEPA OPPTS 870.1100(US EPA 712-C-98-190) and OECD 401 (OECD, 2002). Wistar rats were administered by gavage with Everzol Blue ED-G at a fixed dose of 5,000 mg/kg body weight. At the end of experiment, all animals tolerated the test article well with increasing body weights and no mortality or gross lesions findings reported. The acute oral LD50 of Everzol Blue ED-G was greater than 5,000 mg/kg body weight in rats.