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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study (OECD 402)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
reliability scoring based on 1987 guideline
Deviations:
yes
Remarks:
Source, purity, chemical characteristics of test substance, temperature, light cycle, and humidity not provided; grading scale not provided
GLP compliance:
no
Remarks:
study pre-dates GLP
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-Triazole
- Analytical purity: reoprted as technically pure

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: from the breeder Winkelmann (Borchen)
- Age at study initiation: no data
- Weight at study initiation: 160-180g
- Fasting period before study: no data
- Housing: in tyupe-III Makrolon cages
- Diet (e.g. ad libitum): Altromin R standard diet, ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: Cremophor EL
Details on dermal exposure:
Test substance was applied to shaven dorsal skin. After 24 hours of application, the skin was washed with water and soap.
Duration of exposure:
24 hours
Doses:
1000, 2000 (females only), 2500, 3500, 4000 (females), 5000 mg/kg body weight
No. of animals per sex per dose:
1000 (5 males; 5 females), 2000 (10 females), 2500 (10 males; 10 females), 3500 (10 males; 10 females), 4000 (10 females), 5000 (10 males; 20 females)
Control animals:
not required
Details on study design:
14 day observation period
Statistics:
The calculation of the mean lethal dose (LD50) in carried out using probit analysis.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
4 200 mg/kg bw
95% CL:
> 3 081 - < 5 725
Sex:
female
Dose descriptor:
LD50
Effect level:
3 129 mg/kg bw
95% CL:
> 2 203 - < 3 648
Mortality:
Yes
Clinical signs:
The animals exhibited; reduction in general well-being, accompanied by sedation and breathing disorders. At higher doses, the animals were lying in the abdominal or side position. The symptoms appeared within an hour of administration and were observed for a maximum of up to 13 days after administration.
Body weight:
no data
Gross pathology:
Gross pathology examination of the animals revealed no major changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC1272/2008)
Executive summary:

A guideline study (OECD 402) was performed in rats to calculate LD50 in dermal route. Rats were exposed to 1,2,4 -triazole at 1000, 2000 (females only), 2500, 3500, 4000 (females), 5000 mg/kg body weight (a single exposure), and were observed during 14 days. The mortality of each animal was reported and the LD50 was calculated. The LD50 of 1,2,4-triazole is 4200 mg/kg bw in male rats, and 3129 mg/kg bw in female rats.

1,2,4 -triazole is not classified for acute dermal toxicity according to the regulation EC no.1272/2008 (CLP).