Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Sep 1984 to 15 Oct 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1992
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(4-chloro-phenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butan-2-ol
Cas Number:
94361-06-5
Molecular formula:
C15H18ClN3O
IUPAC Name:
2-(4-chloro-phenyl)-3-cyclopropyl-1-[1,2,4]triazol-1-yl-butan-2-ol

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 18 - 24 g
- Fasting period before study: 18-20 hours prior and 4 hours after dosing
- Diet: Ad libitum (analysed for contaminants)
- Water: Ad libitum except for 2 hours prior and 3 - 4 hours after dosing
- Acclimation period: 3 - 8 days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 25 Sep 1984 to 15 Oct 1984

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
VEHICLE
- Amount of vehicle: 10 mL/kg
Doses:
125, 160, 250, 320, 400, 500, 640 and 800 mg/kg
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: Animals were observed for 1 hour following treatment and at hourly intervals for the remaining of the first day and twice daily for the remaining 14 days.
- Frequency of weighing: Individual body weights on day 1, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic post-mortem examination. The macroscopic appearance of abnormal organs was recorded.
Statistics:
The acute oral LD50 was determined using the probit method of L.C. Miller and M.L. Tainter (Proc. Soc.exper. Biol. Med.~ (1944) p. 26).

Results and discussion

Preliminary study:
A preliminary study was carried out to establish a dosing regime. See table 1 in ''Any other information on results''
Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
200 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
218 mg/kg bw
Based on:
test mat.
Mortality:
See table 2 in ''Any other information on results incl. tables''.
Clinical signs:
other: The most common symptoms were weakness, dizziness, decreased movement, flaccidity, ataxia, laboured and decreased respiration. The first onset of symptoms occurred within 9- 10 minutes after dosing. The longest duration of symptoms lasted 72 hours in the
Gross pathology:
No particular findings were noted on any organ or tissue at necropsy, neither in animals that died nor in the mice which survived the 14 day observation period.

Any other information on results incl. tables

Table 1. Results of preliminary study

Dosage mg/kg

Mortality ratio (no. of deaths) (no. dosed)

Time of death after dosing (hours}

Males                      Females

Males

Females

125

-

0/2

-

-

250

-

0/2

-

-

500

1/2

2/2

74

29,29

1000

2/2

2/2

62,86

23,62

2000

2/2

2/2

14,38

14,38

4000

2/2

2/2

49,98

26,51

Table 2. Mortality in male and female NMR1 mice after oral administration of the test substance

Dose (mg/kg)

Males (dead/treated)

Time to death (days)

Females (dead/treated)

Time death (days)

125

1/5

1

0/5

-

160

1/5

1

1/5

2

250

4/5

1,2

4/5

2, 3

320

4/5

2,3

4/5

2, 3

400

5/5

1, 2, 3

5/5

1, 3

500

5/5

2, 3

5/5

2, 3, 4, 5

640

5/5

2, 3

5/5

2, 3

800

5/5

1, 2, 3

5/5

1, 2, 3, 4

 

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The acute oral LD50 was calculated to be 200 mg/kg for male and 218 mg/kg for female NMRI mice. The test substance is therefore considered toxic to mice after a single dose.
Executive summary:

In a study that was performed in accordance with OECD 401 and according to GLP, 5 male and 5 female NMRI mice were exposed to the test substance to determine the potential to produce toxicity from a single dose via the oral route (gavage). The mice were once exposed at doses of 125, 160, 250, 320, 400, 500, 640 and 800 mg/kg of the test substance dissolved in DMSO. Animals were observed for 1 hour following dosing and at hourly intervals for the remainder of day 1. For the following 14 days animals were observed for symptoms and mortality in the morning and once in the evening.

Results showed that the maximum non-lethal dose was less than 125 mg/kg in male mice and 125 mg/kg in female mice. The minimum lethal dose was 125 mg/kg in males and 160 mg/kg in females. Earliest onset of lethality occurred 14 hours after dosing in the 125 mg/kg male group and in the 800 mg/kg male and female groups. The most common symptoms were weakness, dizziness, decreased movement, flaccidity, ataxia, laboured and decreased respiration. The first onset of symptoms occurred within 9- 10 minutes after dosing. The longest duration of symptoms lasted 72 hours in the 250 mg/kg group. Recovery was complete in the survivors of all groups by 96 hours.

Based on these findings, the acute oral LD50 was calculated to be 200 mg/kg for male and 218 mg/kg for female NMR1 mice. The test substance is therefore considered toxic to mice after a single dose.