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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:
From Sep. 6, 1989 to Dec. 4, 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 401/423)

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
1H-1,2,4-triazole CAS No.288-88-0
Author:
EPA
Year:
2009
Bibliographic source:
US EPA HPV Challenge Program, Test plan Submission, July 2009
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987 followed
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1984 followed
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
reliability scoring based on 2001
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,2,4-TRIAZOL
- Physical state: white solid
- Analytical purity: >98%
- Lot/batch No.: Z81429
- Expiration date of the lot/batch: Aug. 16, 1990

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4 CH-4414 Füllinsdorf
- Age at study initiation: males 8 to 9 weeks; females 9 to 11 weeks
- Weight at study initiation: males 179 to 235 g; females 159 to 199 g
- Fasting period before study: 12 to 18 hours
- Housing: Groups of 5 in Makrolon type-3 cages with standard bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
- Diet (e.g. ad libitum): pelleted standard Kliba 343, Batch 55/89 rat maintenance diet ("Kliba" Klingentalmuehle AG, CH-4303 Kaiseraugst) ad libitum
- Water (e.g. ad libitum): community tap water from Itingen ad libitum
- Acclimation period: one week under laboratory conditions after veterinary examination


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 to 70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: bi-distilled water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg
Doses:
1000, 1500, and 2000 mg/kg
No. of animals per sex per dose:
5 animals/sex/ dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Each animal was examined for changes in appearance and behavior 4 times during day 1 and daily during days 2 to 15. Weighing: Test day 1 (pre-administration), 8, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Statistics:
LD50 LOGIT-ESTIMATION

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 320.39 mg/kg bw
95% CL:
> 1 104.09 - < 1 490.9
Mortality:
refer to attached file
Clinical signs:
refer to attached file
Body weight:
The body weight gain of the surviving animals was not affected by the test article treatment throughout the entire study period.
Gross pathology:
refer to attached file

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Harmful if swallowed Criteria used for interpretation of results: other: CLP (EC1272/2008)
Conclusions:
According this study, 1,2,4-triazole is classified in category 4 according to the Regulation EC no.1272/2008 (CLP) with a LD50 of 1320 mg/kg bw.
Executive summary:

A guideline study (OECD 401) was performed in rats to calculate LD50. Rats were exposed to 1,2,4 -triazole at 1000, 1500, and 2000 mg/kg1000, 1500, and 2000 mg/kg bw (a single exposure), and were observed during 15 days. The mortality of each animal was reported and the LD50 was calculated. The LD50 of 1,2,4-triazole is 1320 mg/kg bw in rats.

1,2,4 -triazole is classified in Category 4 according to the regulation EC no.1272/2008 (CLP).