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

Endpoint summary

Description of key information

The test substance induced maximal irritant effects including necrosis in a reliable dermal irritation study with rabbits. As a result, the test article was classified as corrosive to skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

The test article's potential to cause dermal irritation was assessed in a quality controlled irritation study in New Zealand White rabbits following OECD guideline 404 (CIBA-GEIGY, 850294, 1985). An amount of 0.5 g of the test substance was applied topically to the intact skin of six female New Zealand White rabbits for 4 hours under occlusive dressing. In all animals the test substance caused maximal irritant effects including necrosis which were expected not to be reversible within 14 days. Average scores for erythema and edema measured over 24, 48 and 72 hours after removal of the bandage were 2.66 and 3.33, respectively. The animals were killed for animal protective reasons 7 days after removing the bandage. On account of the necrosis observed, full skin destruction is expected and, therefore, the test substance must be classified as corrosive to skin and eyes.

Eye irritation:

An in vivo test for eye irritation was not performed since the test article was found corrosive to skin and is therefore also regarded as corrosive to eyes.

Justification for selection of skin irritation / corrosion endpoint:
guideline study

Effects on skin irritation/corrosion: corrosive

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, the test substance requires classification for dermal and ocular corrosion under Regulation (EC) No.1272/2008.