Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 21, 1995 - May 21, 1995.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: USA EPA test
Qualifier:
equivalent or similar to guideline
Guideline:
other: Principles and Method of Toxicology
Version / remarks:
1994 / Hayes, A.W.
GLP compliance:
no
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)
EC Number:
305-729-0
EC Name:
Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)
Cas Number:
95009-01-1
Molecular formula:
C18H9CuN6O10S.Na
IUPAC Name:
sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Everlan Brown EFR
- Substance type: Powder
- Composition of test material, percentage of components: -
- Sample is produced in 2004
- Storage condition of test material: Ambient
Specific details on test material used for the study:
- Name of test material: Everlan Brown EFR Dye Powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Source: Laboratory Animal Center, National Taiwan University.
- Age at study initiation: about 5 week old
- Housing: in cage
- Diet: ad libitum
- Water: ad libitum
- Temperature (°C): 25 ± 1 °C
- Humidity (%): 50-70 %
- Photoperiod: 12-hrs dark / 12-hrs light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
yes
Details on study design:
Intoxicant symptoms, symptom occurrence, and death are recorded 1/2, 1, 2, and 4 hours after dosing. From the second day to 14th day, all rats are inspected once daily.
Treated rats are necropsied and all gross pathological changes were recorded.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Table 1. Acute oral toxicity of Everlan Brown EFR Dye Powder in rats

Dose

(mg/kg)

Mortality for 14 days

Male

Female

Total

Control

5000

0/5

0/5

0/5

0/5

0/10

0/10

Table 2. The time course of death caused by the oral administration of Everlan Brown EFR Dye Powder

Sex

Days after administration

0

1

2

3

4

5

6

7

14

Male

Female

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Table 3. Body weight change of rats gavaged with Everlan Brown EFR Dye Powder

Sex

Dose mg/kg

Days after administration

0

7

14

Male

Control

5000

209.0±10.1

204.4±11.2*

232.4±12.8

224.6±11.5*

261.0±12.9

253.0±13.7*

Female

Control

5000

208.4±11.6

201.8±11.5*

230.0±10.7

222.8±11.3*

262.2±12.4

250.6±11.4*

* Significant difference between control and treated group

Table 4. Percentages of body weight change of rats gavaged with Everlan Brown EFR Dye Powder by F-test

Sex

Dose mg/kg

Days after administration

7

14

Male

Control

5000

11.2±1.3

9.9±0.8

24.9±1.1

23.8±2.4

Female

Control

5000

10.4±2.0

10.4±1.4

25.4±2.7

24.2±1.7

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to recommend USA EPA test and good laboratory practice (GLP) guidelines, the LD50 of Everlan Brown EFR Dye Powder was greater than 5000 mg/kg. Therefore, Everlan Brown EFR Dye Powder was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the TACTRI for TXD45ao which is based on the USA EPA test and "Principles and Method of Toxicology (1994)".Wistar rats were administered by gavage with Everlan Brown EFR Dye Powder at a fixed dose of 5,000 mg/kg. 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 Everlan Brown EFR Dye Powder was greater than 5,000 mg/kg.