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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, with limited documentation, acceptable for assessment.

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:
no guideline available
Principles of method if other than guideline:
5 mice per sex per dose are administered a single dose of the test substance via intraperitoneal injection. Clinical signs and body weight are monitored and necropsy is carried out at termination (after 14 days) or after death if an animal died during the study.
GLP compliance:
no

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:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
- Strain: NMRI-Ivanovas mice
- Average weight at study initiation: 23 g (males); 24 g (females)
- Fasting period before study: 15 - 20 h before administration
- Diet: Herilan MRH-Haltung; Eggersmann KG

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
(0.5%)
Details on exposure:
Conc. in vehicle: 7 and 20%

MAXIMUM DOSE VOLUME: 10 mL/kg bw
Doses:
700 and 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: 1 h, 1 d, 2 d, 7 d and 14 d after administration
- Frequency of weighing: at the beginning, after 4 d, 7 d and 14 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:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality occurred.
Mortality:
- 700 mg/kg bw: no mortality occurred.
- 2000 mg/kg bw: no mortality occurred
Clinical signs:
- 700 mg/kg bw: Dyspnoea, apathy, spastic gait, piloerection, convulsions, poor general state.
- 2000 mg/kg bw: Dyspnoea, apathy, spastic gait, piloerection, convulsions, poor general state.
These symptoms were evident shortly after injection and persisted up to 24 hours after application. The effects were fully reversed 48 hours after application.
No data on time of onset and reversibility of the effects.
Body weight:
Body weights (g)

Male (700 mg/kg bw):

At beginning: 28 g
After 4 days: 32 g
After 7 days: 35.6 g
After 13 days: 28.2 g

Male (2000 mg/kg bw):

At beginning: 23 g
After 4 days: 23 g
After 7 days: 26 g
After 13 days: 28.2 g

Female (700 mg/kg bw):

At beginning: 24 g
After 4 days: 26 g
After 7 days: 26.8 g
After 13 days: 28.6 g

Female (2000 mg/kg bw):

At beginning: 24 g
After 4 days: 25 g
After 7 days: 26.4 g
After 13 days: 28.6 g
Gross pathology:
Sacrificed animals:
- Intraabdominal test substance incorporations in the liver; adipose tissue: slightly coloured

Applicant's summary and conclusion