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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1989
Report date:
1989

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:
4'-methoxyacetoacetanilide
EC Number:
226-615-6
EC Name:
4'-methoxyacetoacetanilide
Cas Number:
5437-98-9
Molecular formula:
C11H13NO3
IUPAC Name:
N-[4-(methoxyacetyl)phenyl]acetamide

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, conventional breeding colony
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: air conditioned, single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, and hay, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated, automatic dispenser, 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:
not specified
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 HOURS
Observation period:
3 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 86, 87, 88 each
Time point:
other: mean of 24, 48, 72 h readings
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no signs of irrtation were observed at any reading time
Irritation parameter:
edema score
Basis:
animal: # 86, 87, 88 each
Time point:
other: mean of 24, 48, 72 h readings
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no signs of irrtation were observed at any reading time

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating or corrosive to skin under these test conditions.

These findings do not meet criteria for a classification as corrosive or irritant to skin according to REGULATION (EC) No 1272/2008:

Skin corrosion/irritation: not classsified
Executive summary:

The test item was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. During the observation period of three days no signs of irritation or corrosion were observed (all scores 0) in any animal at any reading time. Thus the test item is not irritating or corrosive to skin under these test conditions.