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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:
May - July, 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
GLP-like quality assurance
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole
EC Number:
401-280-0
EC Name:
1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole
Cas Number:
91273-04-0
Molecular formula:
C19 H38 N4
IUPAC Name:
1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole
Details on test material:
- Physical state: liquid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Tif:RAIf (SPF), F3-crosses of RII 1/Tif x RII 2/Tif
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 193 - 236 g
- Housing: caged individually in Macrolon cages type 2 with standardized soft wood bedding
- Diet: Rat food, NAFAG No. 890, NAFAG AG, ad libitum.
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES:
From: May 8, 1985 To: May 22, 1985

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: back of the rat
- % coverage: at least 10 %
- Type of wrap if used: covered with a gauze-lined semiocclusive dressing, which was fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg bw
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
Duration of exposure:
24h
Doses:
One single dose (2000 mg/kg bw).
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations:
Mortality: daily, a.m. and p.m. on working days, a.m. on weekends
Signs and Symptoms: 1, 2, 3 and 5 hours post dose, then daily
Body weight: on days 1, 7, and 14
- Necropsy of survivors performed: yes, at the end of observation period
Statistics:
From the body weights, the group means and their standard deviations were calculated.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived.
Clinical signs:
Dyspnea, exophthalmos, ruffled fur, and abnormal body positions were seen, being common symptoms in acute tests. Additionally, sedation was observed 5 hours after application. Slight erythema was observed on day 1. The animals recovered within 9 days.
Body weight:
Body weight development was not impaired.
Gross pathology:
No deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Upon an acute dermal administration and a 14 day post-treatment observation period, the LD50 (with 95% confidence limits calculated where possible) was determined to be greater than 2000 mg/kg body weight.
Executive summary:

In an acute dermal toxicity study following OECD guideline 402 and under quality controlled conditions, 5 male and 5 female rats were dermally exposed to the test item for 24 hours at a limit dose of 2000 mg/kg body weight. The test article was used undiluted and applied at a volume of 2 ml/kg body weight to the clipped back of the animals. It was covered with a gauze-lined semiocclusive dressing, which was fastened around the trunk with an adhesive elastic bandage. After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. All animals were observed 1, 2, 3 and 5 hours postdose and once daily for 14 days for signs and symptoms. The animals were observed twice daily for mortality. Body weights were recorded on days 1, 7 and 14. All animals were submitted to a gross necropsy at the end of the observation period. All animals survived the 2000 mg/kg dermal application. Dyspnea, exophthalmos, ruffled fur, and abnormal body positions were seen, being common symptoms in acute tests. Additionally, sedation was observed 5 hours after application. Slight erythema was observed on day 1. The animals recovered within 9 days. No deviations from normal morphology were found during necropsy. Based on these observations, the dermal LD50 value of the test item was greater than 2000 mg/kg body weight.