Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
September 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: Tif: RAIf
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy premises
- Weight at study initiation: from 160 to 180 grams
- Fasting period before study: animals fasted overnight
- Housing: housed in group of 5 in Macrolon cages (type3)
- Diet (e.g. ad libitum): ad libitum NAFAG, Gossau SG
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours dark / 10 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 2% CMC
Doses:
3170, 4640, 6000, 7750 and 10000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: physical condition
Statistics:
LD50 including 95 % confidence limits were calculated by the probit analysis method (Goulden A., Methods of Statistical Analysis, John Wiley and Sons, 1960, 3rd printing, pages 404-408).

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 3 170 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 7 993 mg/kg bw
Based on:
test mat.
95% CL:
ca. 6 335 - ca. 10 085
Mortality:
Mortality observed for concentrations above 3170 mg/kg body weight. See Table 1 for overall results.
Clinical signs:
Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmos, curved position, diarrhoea and ruffled fur.
Gross pathology:
No substance related gross organ changes were seen.

Any other information on results incl. tables

Rate of deaths

Dose

mg/kg

Concentration %

of formulation

N° of animals

(M, male

F, female)

Died within

1 hour

24 hours

48 hours

7 days

14 days

 

 

M

F

M

F

M

F

M

F

M

F

M

F

3170

30

5

5

0

0

0

0

0

0

0

0

0

0

4640

50

5

5

0

0

0

0

0

0

1

1

1

1

6000

50

5

5

0

0

0

0

0

2

0

2

0

2

7750

50

5

5

0

0

1

2

3

3

3

3

3

3

10000

50

5

5

0

0

0

4

1

5

1

5

1

5

 

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
The acute oral LD50 of substance in rats of both sexes observed over a period of 14 days is 7993 (6335-10085) mg/kg.
LD50 = 5834.9 mg/kg bw based on active ingredient.
Executive summary:

Method

The test substance was tested for acute toxicity for oral route following a procedure similar to OECD 401.

The rats were kept at a room temperature of 22 ± 1 °C, at a relative humidity of 55 ± 5 % and on a 10 hours light cycle day. They received ad libitum rat food and water. Prior to treatment the animals were adapted for a minimum of 4 days and the initial body weight ranged from 160 to 180 grams.

During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages (type 3).

Physical condition and rate of deaths were monitored throughout the whole observation period.

The substance was administered by oral intubation at the following concentrations: 3170, 4640, 6000, 7750 and 10000 mg/kg body weight. 5 rats per sex per dose were exposed at each concentration. Dyspnoea, exophtalmus, ruffled fur, curved body position and a transient diarrehea were seen.

Results

The LD50 observed in rats was 5834.9 mg/kg bw.

The animals were submitted to a necropsy whenever they died, survivors at the end of the observation period.