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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:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(no GLP)
Principles of method if other than guideline:
The study was conducted according to an internal BASF method which in principle was comparable to the OECD guideline 401. A test group consisting of 5 animals/dose was treated by single gavage with an aqueous solution of the test substance. Animals weight was taken prior to application, at regular intervals during the observation period and one day before termination. The animals were observed for mortality and for clinical signs of toxicity for a period of 14 days. Animals that died during the observations period were subjected to necropsy. At the end of the observation period, the surviving animals were sacrificed for the purpose of necropsy. The LD50 value was estimated on the basis of the observed mortalities
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name as cited in document: Lilial
- Analytical purity: 99%
- Batch No.: not reported
- Physical state: liquid

Test animals

Species:
rat
Strain:
other: Sprague Dawley- Hagemann
Sex:
male/female
Details on test animals and environmental conditions:
- Age at study initiation: not reported
- Body weight at study initiation: Range (male); 210-290 g, range (female); 170 - 220 g
- Fasting period before study: 15-20 h before application
- Diet: Herian MRH- Haltung; H. Eggermann KG

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 6.8%; 10%; 14.7%; 21.5%; 31.6% in 0.5% CMC
- Amount of vehicle: 10 ml/kg bw
- Concentration of vehicle: 0.5 %

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw


Doses:
681; 1000; 1470; 2150; 3160 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: prior to application (day 1), on day 4 or 5, day 8 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy
Statistics:
Test for homogeniety: chi squared test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 390 mg/kg bw
95% CL:
1 019 - 1 867
Remarks on result:
other: LD50 was determined by probit analysis (Slope factor 1.94). Finney, D. J., Probit analysis, Cambridge University Press, 3rd Edition., 1971.
Mortality:
see table 1 in " Remarks on results..."
Clinical signs:
see table 2 in " Remarks on results...".
Body weight:
see table 3 in " Remarks on results..."
Gross pathology:
No abnormality was seen in survivors at the end of the study period.
Animals found dead:
- Heart: acute dilation, acute hyperemia
- Liver: clay yellow, grey-whitish, colouring of the periphery of the lopes

Any other information on results incl. tables

Table 1: Progression of mortality within the observation period

Dose (mg/kg bw)

No. of animals

Mortality within

1h

1 d

2 d

7 d

14 d

681

5M

0/5

0/5

0/5

1/5

1/5

5F

0/5

0/5

0/5

0/5

0/5

1000

5M

0/5

1/5

1/5

1/5

1/5

5F

0/5

4/5

4/5

4/5

4/5

1470

5M

0/5

2/5

2/5

2/5

2/5

5F

0/5

2/5

2/5

2/5

2/5

2150

5M

0/5

2/5

2/5

2/5

3/5

5F

0/5

2/5

3/5

3/5

3/5

3160

5M

0/5

1/5

3/5

5/5

5/5

5F

0/5

2/5

3/5

5/5

5/5

Table 2: Summary of the clinical signs that were recorded

681 mg/kg

1000 mg/kg

1470 mg/kg

2150 mg/kg

3160 mg/kg

Dyspnea

xxx

xxx

xxx

xxx

xxx

Apathy

xxx

xxx

xxx

xxx

xxx

Abnormal position

xxx

xxx

xxx

xxx

xxx

Drunken gait

xxx

xxx

xxx

xxx

xxx

Atony

xxx

xxx

xxx

Loss of pain reflex

xxx

Loss of corneal reflex

xxx

Narcosis resembling state

xxx

Tremor

xxx

Spastic gait

xxx

xxx

xxx

xxx

xxx

Biting fit

xxx

Rough fur coat

xxx

xxx

xxx

xxx

xxx

Diarrhea

xxx

Skin erythema

xxx

xxx

xxx

Dehydration

xxx

xxx

xxx

Salivation

xxx

Poor general condition

xxx

xxx

xxx

xxx

xxx

xxx symptoms observed

Table 3: Mean body weights after 14 days

Male

Female

Dose (mg/kg bw/d)

Mean body weight after 13 days

Mean body weight after 13 days

681

270 (n=4)

241(n=5)

1000

278 (n=4)

232 (n=1)

1470

268 (n=3)

194 (n=3)

2150

260 (n=2)

203 (n=2)

3160

-

-

Applicant's summary and conclusion