1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Deviations from OECD Guideline adopted 2002: occlusive treatment was used.

GLP compliance:

yes

Test material

Test material information

Constituent 1

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:

bis(2-ethylhexyl)[(1H-1,2,4-triazol-1-yl)methyl]amine

Details on test material:

- Physical state: liquid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2 to 3 kg
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%):30-70 %
- Photoperiod (hrs dark / hrs light): 12h

IN-LIFE DATES: From 02 May, 1985 To: 14 May, 1985

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated flank served as control

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h (The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches)

Observation period:

7 days

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: an area of at least 6 cm² was shaved on both flanks of the animals; a gauze patch bearing 0.5 g of the test substance was applied to one flank, a control gauze patch to the contralateral flank
- Type of wrap if used: patch was loosely covered with an aluminum foil and held in place for 4 hours by an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(all animals)

Time point:

24/48/72 h

Score:

2.66

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Remarks on result:

other: necrosis observed on day 7

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

(all animals)

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Remarks on result:

other: necrosis observed on day 7

Irritant / corrosive response data:

The test item induced severe irritant effects (including necrosis) which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 7 days after removing the bandage.

Other effects:

Loss of weight was observed in all animals on day 3.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Under the experimental conditions employed, the test substance induced maximal skin irritation when applied to the clipped albino rabbit skin. On account of the necrosis observed, full skin destruction is expected and, therefore, the test article must be classified as corrosive.

Executive summary:

In a primary dermal irritation study according to OECD guideline 404 and under GLP-like quality controlled conditions, three male New Zealand White rabbits were dermally exposed to the test item for four hours under occlusive dressing.

0.5 g of the test substance was placed on a clipped but intact area of the flank and held in place by a gauze patch loosely covered with an aluminum foil (36 cm²) and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. The test substance induced maximal irritant effects including corrosion in all animals which were expected not to be reversible within 14 days. The animals were killed for animal protective reasons 7 days after removing the bandage. Weight loss was observed in all animals on day 3. Based on this result, the test substance is considered to be corrosive to skin and eye.