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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
Study period:
25 Sep - 21 Oct 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: M.A.F.F. in Japan 59 NohSan N° 4200 (1985)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
446-630-3
EC Name:
-
Cas Number:
181587-01-9
Molecular formula:
C13H9Cl2F3N4OS
IUPAC Name:
5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethanesulfinyl)-1H-pyrazole-3-carbonitrile
Details on test material:
- Name of test material (as cited in study report): RPA 107382
- Analytical purity: 93%
- Lot/batch No.: CDR 9706

Test animals

Species:
rat
Strain:
other: Wistar (AF) RJ: WI (IOPS AF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: R. Janvier, Le Genest St Isle, France
- Age at study initiation: 6 weeks (group 1) and 7 weeks (group 2)
- Weight at study initiation: 162–224 g (males) and 147–185 g (females)
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: rats were housed individually in suspended stainless steel, wire mesh cages.
- Diet: certified Rodent Pellet diet “M 20contrôlé” (Pietrement, Provins, France), ad libitum
- Water: filtered and softened tap water, ad libitum
- Acclimation period: 6 days for group 1 and 13 days for group 2

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20–24
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30 Sep 1997 To: 14 Oct 1997 for group 1 and From: 07 Sep 1997 To: 21 Oct 1997 for group 2

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% methylcellulose in distilled water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
Group 1: 5000 mg/kg bw
Group 2: 7080 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each animal was weighed on Day -1, 1, 8, 15 for group 1 and Day 1, 8, 15 for group 2 and when found dead. Clinical signs were recorded starting on Day 1 (at least twice) and every day through Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: necropsy included macroscopic examination of abdominal and thoracic cavities, major organs and tissues.
Statistics:
For body weights, mean values and standard deviations were calculated for each sex.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 080 mg/kg bw
Based on:
test mat.
Mortality:
5000 mg/kg bw: 1/5 males and 2/5 females died (Day 2)
7080 mg/kg bw: 0/5 males and 1/5 females died (Day 3)
Clinical signs:
5000 mg/kg bw: animals who died showed clinical signs of reduced motor activity, palpebral ptosis and hunched posture.
7080 mg/kg bw: no clinical signs were observed.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy revealed no substance-related findings. Individual findings are given in Table 1 under "Any other information on results incl. tables".

Any other information on results incl. tables

Table 1. Results of acute oral toxicity

Dose
[mg/kg bw]

Mortality

Clinical signs

Gross pathology

 

N*

%

Time of death

N*

Duration

N*

Observation

Males

5000

1/5

20

Day 2

1/5

Day 1

1/5

stomach dilatation (marked)

7080

0/5

0

---

0/5

---

0/5

no abnormality in all organs

Females

5000

2/5

40

Day 2

1/5

Day 1 - day 2

2/5

autolysis (moderate); stomach, black spots

7080

1/5

20

Day 3

0/5

---

2/5

liver, white area on left lobe; stomach, black spots                              

N* = number of animals/ number of animals used

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified