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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline with acceptable restrictions - no GLP - reduced documentation

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: solid
- Analytical purity: a formulation containing approx. 87% of the dye (100% pure)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gassner
- Mean weight at study initiation: 150g (female) and 200 g (male)
- Fasting period before study: 15 h- 20 h before administration


ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
(0.5%)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw.
Doses:
5000 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: <15 min - 5h, 1 d, 4 d, 5 - 8 d, 11 - 14 d after administration
- Frequency of weighing: at the beginning, and then after 4 d, 7 d and 13 d after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Clinical signs:
Faeces coloured blue 24 hours after application of the test substance. This effect was no longer evident from 48 hours till end of the observation period. The animals were all in a good general condition.
Body weight:
After 7 days, slight reduction in body weights of male animals. By the next observation time point, bodyweight gain was normal.
Gross pathology:
No abnormalities detected.
Other findings:
A preliminary test was performed with 1000 and ca. 5000 mg/kg bw using 2 female rats/dose. None of the animals died. No clinical sign of toxicity was reported. No abnormality was seen at gross necropsy.

Any other information on results incl. tables

Table 1: Mean weight (g)

 

 

5000 mg/kg bw

Male animals

At beginning

200

After 4 days

196

After 7days

186.4

After 14 days

235

 

 

 

Female animals

At beginning

150

After 4 days

178

After 7days

186.8

After 14 days

192.6

 

Applicant's summary and conclusion