Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May. 1, 1984 to May. 29, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

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)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TK 13110 (CG 21-1201)
- Physical state: Solid
- Lot/batch No.: EP 1
- Purity: Pilot sample

Test animals

Species:
rat
Strain:
other: Tif:RAIt (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 to 8 weeks
- Weight at study initiation: 175 to 215 g
- Fasting period before study: Prior to dosing, animals were fasted overnight.
- Housing: Caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société 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): ad libitum
- Acclimation period: Not reported

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

IN-LIFE DATES: From: May 1, 1984 To: May 15, 1984

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Distilled water containing 0.5% carboxymethyl cellulose and 0.1% polysorbate 80
Details on oral exposure:
VEHICLE
- Justification for choice of vehicle: Not provided.

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight

Doses:
5000 mg/kg body weight
No. of animals per sex per dose:
5/sex/dose
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality was observed daily (twice per day on working days and once on weekend days).
Body weight - recorded on days 1, 7, 14, and at death
- Necropsy of survivors performed: yes
Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
- Other examinations performed:
Clinical signs - observed daily
Statistics:
From the body weights, the group means and their standard deviation were calculated. Where feasible, 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
Mortality:
No deaths were observed.
Clinical signs:
Dyspnoea, exophthalmus, ruffled fur, and curved body position were seen in all animals, being common symptoms in acute tests. All animals recovered within 10 days. In addition, a slight tremor was observed shortly after application.
Body weight:
Mean body weight measurements were normal (see table in Remarks on results including tables and figures).
Gross pathology:
No gross lesions were found at necropsy.

Any other information on results incl. tables

Body weights and standard deviations (g)

  Males Females
Dose (mg/kg) Day 1 Day 7 Day 14 Day 1 Day 7 Day 14
5000 205(sd: 8.2) 266 (sd: 9.6) 320 (sd: 12.9) 180 (sd: 6.3) 207 (sd: 7.8) 218 (sd: 3.8)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 after single oral administration to rats, observed over a period of 14 days is greater than 5000 mg/kg body weight.