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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (no GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Principles of method if other than guideline:
The study was conducted according to an internal BASF method which was in principle comparable to the OECD guideline 401. A test group consisting of 5 animals/sex/dose was treated by single gavage with an aqueous solution of the test substance. The animals were weighed prior treatment only. The animals were observed for mortality and for clinical signs of toxicity for a period of 14 days. Decedents were subjected to necropsy. At the end of the observation period, the surviving animals were sacrificed (CO2 aphyxiation) for the purpose of necropsy. The LD50 value was estimated on the basis of the observed mortalities using the Lichtfield and Wilcoxon method

GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Analytical purity: > 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma Gassner/Ottobrunn
- Age at study initiation: no data
- Mean weight at study initiation: ♀ = 150g; ♂ = 160g
- Diet: ad libitum (Altromin "R" from Altromin GmbH, Lage)
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 - 21.3 ml/kg bw

DOSAGE PREPARATION (if unusual):
The test substance was administered as a 20 and 30% aqueous solution
Doses:
2, 2.5, 3.2, 4, 5, 6.4 ml/kg bw
conversion with density 0.99g/ml) = 1980, 2475, 3168, 3960, 4950, 6336 mg/kg bw
No. of animals per sex per dose:
5/sex/dose for all doses except 3168 mg/kg bw where 10/sex/dose were employed
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of mortality check: after 1 hour, 24 hours, 48 hours, 7 days and 14 days
- 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:
3 455.1 mg/kg bw
95% CL:
2 978.9 - 4 007.5
Remarks on result:
other: At all doses symptoms included: apathy, dyspnoea, partly cyanosis, intermittent breathing, crouching position, agitation.
Mortality:
- 1980 mg/kg bw: 1/5♀, 0/5♂
- 2475 mg/kg bw: 1/5♀, 0/5♂
- 3168 mg/kg bw: 5♀, 3♂
- 3960 mg/kg bw: 5/5♀, 3/5♂
- 4950 mg/kg bw: 3/5♀, 4/5♂
- 6336 mg/kg bw: 5/5♀, 5/5♂
Clinical signs:
At all doses symptoms included: apathy, dyspnoea, partly cyanosis, intermittent breathing, crouching position, agitation.
Body weight:
no data
Gross pathology:
- Decedents: liquid accumulation in the abdomen (10 animals), smudgy snout (4 animals), liver necrosis (1 animal)
- Sacrificed animals: multiple cases (9 animals) of reduced retroperitoneal fat pads, distended gastrointestinal tract

Applicant's summary and conclusion