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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
Version August 6, 1987
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: solide, insoluble in water
- Analytical purity: commercial grade
- Lot/batch No.: EN 81581.62
- Stability under test conditions: guaranteed
- Storage condition of test material: room temperature
Specific details on test material used for the study:
- Physical state: solide, insoluble in water
- Analytical purity: commercial grade
- Lot/batch No.: EN 81581.62
- Stability under test conditions: guaranteed
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: albino rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RAIf (SPF) hybrids (of RII/1 x RII/2) rats from Ciba-Geigy Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 204-236 g
- Fasting period before study: overnight prior to dosing
- Housing: caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin)
- Diet (e.g. ad libitum): Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland); ad libitum
- Water (e.g. ad libitum): drinking water; ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS (the animal room was air conditioned)
- Temperature (°C): 22±3°C
- Humidity (%): 55±15%
- Air changes (per hr): approx. 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 250 mg/mL

MAXIMUM DOSE VOLUME APPLIED:
20 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 and weighing: mortality twice on working days and once on weekend days; signs and symptoms daily; body weight at start and on days 7 and 14
- Necropsy of survivors performed: yes; at the end of the observation period
Statistics:
From the body weights, the group means and their standard deviations were calculated

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality was observed at this unique dose level
Mortality:
No mortality occurred
Clinical signs:
- Dyspnea, exophthalmos, ruffled fur, and curved body position were seen, being common symptoms in acute tests.
- Additionally, a red discoloration of the body was observed from day 1 to 4 after administration.
- The animals recovered within 11 days.
Body weight:
No adverse effects observed (see Table 1)
Gross pathology:
No deviations from normal morphology were found at necropsy

Any other information on results incl. tables

Table 1: Mean body weights (g) and standard deviation

Dose level (mg/kg bw)

Males

Females

Day 1

Day 7

Day 14

Day 1

Day 7

Day 14

5000

227±6.2

265±7.4

306±7.6

212±7.5

211±13.7

224±14.3

 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information