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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2,5-dimethoxyphenyl)acetamide
EC Number:
222-423-1
EC Name:
N-(2,5-dimethoxyphenyl)acetamide
Cas Number:
3467-59-2
Molecular formula:
C10H13NO3
IUPAC Name:
N-(2,5-dimethoxyphenyl)acetamide
Details on test material:
- Name of test material (as cited in study report): Acetchinonbase TTRS

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG breeding colony
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: in air condioned rooms in single cages
- Diet: Altromin 2123 ad libitum and 15 gram hay
- Water: deionized and chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 50 +/-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
500 mg test item mixed with 0.4 ml 0.9% NaCl-solution in water.
Duration of treatment / exposure:
Exposure period: 4 hours.
After patch removal remnant test substance was removed with lukewarm tap water.
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: plaster and bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 hours
- Evaluation: 30 - 60 min, 24 hrs, 48 hrs and 72 hrs after patch removal

SCORING SYSTEM:
erythema: 0 - 4; edema: 0 - 4;

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
edema score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Irritant / corrosive response data:
no signs of irritation/corrosion at any time
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this study N-(2,5-dimethoxyphenyl)acetamide is not irritating to the rabbit skin
Executive summary:

3 New Zealand White rabbits were tested for skin irritation with N-(2,5-dimethoxyphenyl)acetamide according to OECD 404. 500 mg of the test substance mixed with 0.4 ml physiol. saline were tested under semiocclusive coverage. The exposure period was 4 hours. After removal of the patch the remnant test substance was removed with lukewarm tap water. The observation period was 72 h. None of the animals showed any signs of skin irritation or corrosion at any time.