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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Oct. 7, 2003 to Dec. 17, 2003
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:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
other: limit test
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1H-1,2,4-triazole, sodium salt
EC Number:
255-280-9
EC Name:
1H-1,2,4-triazole, sodium salt
Cas Number:
41253-21-8
Molecular formula:
C2H3N3.Na
IUPAC Name:
sodium 1,2,4-triazol-1-ide
Details on test material:
- Name of test material (as cited in study report): 1, 2, 4-TRIAZOLE, SODIUM SALT
- Physical state: White powder
- Analytical purity:99%
- Lot/batch No.: 0421
- Expiration date of the lot/batch: August 2004
- Storage condition of test material: room temperature, protected from light and humidity

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: 8 weeks old
- Weight at study initiation: 293 ± 8 g for males and 240 ± 3 g for females
- Housing:During the acclimation period, one to seven animals of the same sex were housed in polycarbonate cages with stainless steel lid. During the treatment period, the animals were housed individually in polycarbonate cages with stainless steel lid. Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet (e.g. ad libitum): free access to A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: 5 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: October 7, 2003 To: October 21, 2003

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal area
- % coverage: 10%
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test item was removed using a moistened cotton pad.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
Duration of exposure:
24 hours
Doses:
Single dose of 2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: Observations were made at least once daily until day 15
- Frequency of observations and weighing:The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15. The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Mortality:
No deaths occured during the study (0% mortality).
Clinical signs:
No clinical signs were observed during the study.
Crusts were noted in 4/5 females and 1/5 males between day 2 and the end of the observation period (day 15). Dryness of the skin was also recorded in 2/5 females from day 11 up to day 14.
Body weight:
A slightly reduced weight gain or a slight body weight loss was seen in 3/5 females during the first week of the study. The overall body weight gain of the other animals was similar to that of CIT historical control animals.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (EC1272/2008)
Conclusions:
Under experimental conditions, the dermal LD0 of the test item 1, 2, 4-TRIAZOLE, SODIUM SALT is equal to or higher than 2000 mg/kg in rats.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item does not present a significant acute toxic risk in contact with skin.
Executive summary:

Groups of 5 male and female rats were exposed to 1, 2, 4-TRIAZOLE, SODIUM SALT at 2000 mg/kg bw by dermal route (semiocclusive) during 24 hours. Observations were made at least once daily until day 15. No deaths occured during the study (0% mortality), and no clinical signs were observed during the study.

Under experimental conditions, the dermal LD0 of the test item 1, 2, 4-TRIAZOLE, SODIUM SALT is equal to or higher than 2000 mg/kg in rats.According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item does not present a significant acute toxic risk in contact with skin.