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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
13.04.2009 -24.04.2009
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:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2004
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: MAFF Japan Agricultural Chemicals Regulation Laws Notification 12 Nousan 8147
Version / remarks:
2000
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Amino-5-cyano-N,3-dimethylbenzamide
Cas Number:
890707-29-6
Molecular formula:
C10H11N3O
IUPAC Name:
2-Amino-5-cyano-N,3-dimethylbenzamide
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania
- Age at study initiation: Young adult, male
- Weight at study initiation: 2714–3002 g
- Housing: Animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards.
- Diet: Approx. 125 grams PMI® Nutrition International, LLC Certified Rabbit LabDiet® (#5322), daily
- Water: Tap water, ad libitum
- Acclimation period: At least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22
- Humidity (%): 30-70
- Air changes (per hr): Not recorded
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
The test substance was moistened with deionised water to form a thick paste
Amount / concentration applied:
TEST MATERIAL
- Amount applied: Single dose of 0.5 g
VEHICLE
- Amount applied: 0.4 mL deionised water to form a thick paste
Duration of treatment / exposure:
4 hours
Observation period:
72 hours after test substance removal
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: Semi-occusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
1, 24, 48, 72 hours (rabbit initially treated also examined immediately after test substance removal)

SCORING SYSTEM:
- Method of calculation: According to Draize Scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the mean degree of skin reaction observed at 24 to 72 hours, classification by the dermal route is not required.
Executive summary:

The acute dermal irritation potential of the test substance was investigated according to OECD Guideline 404.


The test substance was applied as a single 0.5 g dermal dose to the shaved intact skin of a single New Zealand White rabbit. Since no corrosion occurred, 2 additional rabbits were treated. The test substance, moistened with 0.4 mL of deionized water, was applied to a 6 cm² area of skin. The application area was covered with a 2-ply gauze square which was held in place with non-irritating tape and covered with porous tape for a semi-occlusive dressing. The rabbits were exposed to the test substance for 4 hours after which the test substance was removed. Test sites were evaluated and scored by the method of Draize for signs of dermal irritation approximately 60 minutes, and 24, 48, and 72 hours after test substance removal. The rabbit that was initially treated was also examined immediately after test substance removal.


The rabbits exhibited no dermal irritation during the study. No clinical signs of toxicity were observed, and no body weight loss occurred.


According to the Globally Harmonized System (GHS) of classification and labeling of chemicals and under the conditions of this study, classification is not required.