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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-04-01 to 2000-02-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
updated guideline, adopted: July 17, 1992
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
443-010-4
EC Name:
-
Cas Number:
53641-10-4
Molecular formula:
C14H15ClN2O4
IUPAC Name:
N-[3-chloro-4-(3-oxobutanamido)phenyl]-3-oxobutanamide
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
-Species: New Zealand albino rabbit
-Sex: female
- Origin: Charles River Deutschland GmbH, 88353 Kißlegg
- Weight at study initiation: 2.9 – 3.4 kg
- Housing: in fully air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum; and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: at least seven days
- Animal identification: numbered ear tags

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Lighting time: 12 hours daily

Test system

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
Deionized water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
Examination of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Erythema, eschar and edema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.
Number of animals:
3
Details on study design:
About 24 hours before the start of the study the fur was mechanically removed from the dorsal skin of the animals over an area of approximately 25 cm2. Only animals with intact skin were used.
Each animal was treated with 0.5 g test item pasted with 0.5 ml deionized water. The substance was evenly distributed over the whole surface of a 2.5x2.5 cm cellulose patch on a piece of surgical plaster. The paster was fixed to the prepared skin area and then covered with semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No signs of irritation occurred during the whole observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Based on the results of this study the test item is not considered to be irritating to skin according to CLP regulation.
Conclusions:
No signs of irritation occurred during the whole observation period.
Executive summary:

No signs of irritation occurred during the whole observation period when applying the test substance on the skin of rabbits according to OECD TG 404.Therefore, based on the results of this study the test item is not irritating to skin.