1,2,4-triazole

Acute Toxicity: oral

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

Reference

Reference 1

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 2

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987 followed

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

1984 followed

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

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

Test material information

Constituent 1

Reference substance name:

1,2,4-triazole

EC Number:

206-022-9

EC Name:

1,2,4-triazole

Cas Number:

288-88-0

Molecular formula:

C2H3N3

IUPAC Name:

1H-1,2,4-triazole

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 or test system 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:

other: refer to attached file

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).