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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
from March 21 to April 04, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Acid Green 073:2
IUPAC Name:
Acid Green 073:2
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: Tif:RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 175-210 g
- Fasting period before study: overnight
- Housing: caged in group of 5 in Macrolon cages type 4 (Société Parisienne des sciures, Pantin)
- Diet (e.g. ad libitum): ad libitum, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland)
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days or until symptoms have disappeared
- Frequency of observations and weighing: daily for mortality and sign or symptoms; on days 1, 7, 14 and at death for body weight
- Necropsy of survivors performed: yes
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No dead rats observed.
Clinical signs:
Dyspnoea, exophthalmus, ruffled fur and curved body position were seen. In addition, a transient diarrhoea was observed. The surviving animals recovered within 11 days.
Gross pathology:
No gross lesions were found at necropsy.

Any other information on results incl. tables

signs and symptoms

Observations

Exposure day:

hours           

Days of post-exposure period

1

2

3

5

1

2

3

4

5

6

7

8

9

10

11

12

13

>13

                        5000 mg/kg

dyspnoea

xx

xx

xx

xx

x

x

x

x

x

x

x

x

x

x

 

 

 

 

exophthalmus

x

x

x

x

x

x

x

x

x

x

x

x

x

 

 

 

 

 

ruffled hair

x

x

x

x

x

x

x

x

x

x

x

x

 

 

 

 

 

 

diarrhoea

 

x

x

x

 

 

 

 

 

 

 

 

 

 

 

 

 

 

body position curved

x

x

x

x

x

x

x

x

x

x

 

 

 

 

 

 

 

 

 x=slight              xx=moderate                   xxx=marked

body weights and standard deviations

 

males

females

dose mg/kg

day 1

day 7

day 14

day 1

day 7

day 14

5000

203 / 5.1

275 / 10.9

315 / 13.4

182 / 8.0

218 / 11.3

231 / 11.5

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 5000 mg/kg body weight.
Executive summary:

Method

The test substance was tested for acute toxicity for oral route on rats following the OECD guideline 401. The strain chosen for the test was: Rat, Tif:RAIf, F3-crosses of RII 1/Tif x RII 2/Tif. They were caged in groups of 5 in Macrolon cages type 4 with food and water freely available.

Prior to dosing, the animals were fasted overnight. The animals were allocated to the different dose groups by random selection.

The test substance was administered orally by gastric intubation (gavage) at a dose level of 5000 mg/kg bw on 5 males and 5 females. The observation period was 14 days or until all symptoms have disappeared.

Spontaneously dying animals were submitted to a gross necropsy; survivors at the end of the observation period.

No deaths were observed during the exposure and post exposure period and no gross lesions were found at necropsy.

Results

The LD50 observed was higher than 5000 mg/kg bw.

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