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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study without detailed documentations

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 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
reliability scoring was based on 2002 guideline
Deviations:
yes
Remarks:
Chemical characteristics of test substance and temperature, light cycle, and humidity not provided; grading scale of irritation not included and an incorrect number of animals were used
GLP compliance:
no
Remarks:
study pre-dates GLP requirements

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: reported as technically pure

Test animals

Species:
rabbit
Strain:
New Zealand White
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: 3-4kg
- Fasting period before study: no data
- Housing: singly in standard rabbit cages
- Diet (e.g. ad libitum): Rabbit food 222 (Hoeing co.), ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: hairless skin on ears
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Small cellulose patches (1.5 cm X 1.5 cm) with 500 mg of the test substance applied was attached to skin of the ears of rabbits with an adhesive dressing for 24 hours.
Duration of treatment / exposure:
24 hours of exposure
Observation period:
7 days
Number of animals:
2

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
A score of 0 for all time points, factors and animals.
Other effects:
No changes for up to 7 days after application.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation EC no.1272/2008 (CLP)
Conclusions:
In this study, mean erythema score and mean edema score are equal to 0 : 1,2,4-triazole is not a skin irritant.
Executive summary:

A non GLP Acute Dermal Irritation / Corrosion test comparable to OECD 404 guideline was carried out with 1,2,4 -triazole. The test substance was applied undiluted on a occlusive patch on hairless skin on ears. The test material induced no erythema and no edema on two animals.

Under the experimental conditions, the test substance is not irritant and is not classified according to regulation EC no.1272/2008 (CLP).