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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid
EC Number:
689-732-5
Cas Number:
956317-36-5
Molecular formula:
C10H9N3O2
IUPAC Name:
5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid
Details on test material:
Purity > 98 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products Inc., PA, USA.
- Age at study initiation: ca 4.5 months.
- Weight at study initiation: 2.9 - 3.3 kg.
- Housing: 1/sex/cage.
- Diet (e.g. ad libitum): PMI Rabbit Chow, ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled, but not specified.
- Humidity (%): Not specified.
- Air changes (per hr): Not specified.
- Photoperiod (hrs dark / hrs light): 12-hours light/dark.

IN-LIFE DATES: From: March 24, 2009 To: March 27, 2009

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g / site.
- Concentration (if solution): Moistened with 0.4 mL distilled water to form a paste.
Duration of treatment / exposure:
Single Application
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm (6.25 cm2)
- % coverage: ca 10%
- Type of wrap if used: Gauze patch, under porous (semi-occlusive) dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Ditilled water
- Time after start of exposure: 4 hours (end of exposure)

SCORING SYSTEM: Erythema and edema were scored according to the numerical Draize Scale. The skin was also evaluated for ulceration, necrosis and evidence of tissue destruction.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: All
Score:
ca. 0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Erythema or edema were not evident at 60 minutes, or at 24, 48 and 72 hours after patch removal.
Other effects:
There were no adverse clinical findings or effects on body weight.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Given that the mean scores for both erythema and edema were 0, the test article was considered to be non-irritant.
Executive summary:

The test article was applied to the un-abraded skin of 3 male New Zealand White rabbits under a semi-occlusive dressing. The test article was applied at 0.5 g / site and was moistened with 0.4 mL of distilled water to form a paste. The test article was kept in contact with the skin for 4 hours. Residual test article was removed with distilled water prior to scoring. Test sites were scored for dermal irritation at 60 minutes and at 24, 48 and 72 hours following patch removal (Draize scale).

Given that the mean scores for both erythema and edema were 0, the test article was considered to be non-irritant.