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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is comparable to OECD Guideline 404 with acceptable restrictions (partly limited documentation, e.g. no scoring 48 h after exposure; ca. 1 mL test substance applied, exposure period 20 h and occlusive coverage conditions [worst case scenario]).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Skin irritation was tested using an internal method (BASF test) which is similar to OECD 404.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-dimethylacetamide
EC Number:
204-826-4
EC Name:
N,N-dimethylacetamide
Cas Number:
127-19-5
Molecular formula:
C4H9NO
IUPAC Name:
N,N-dimethylacetamide
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material: dimethylacetamide (DMAC)
- Purity: 99.9 %
No further details available.

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.35 kg (male), 2.63 kg (female)

No further details available.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: no data (presumably shaved)
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: approximately 1 mL

The application site (dorsal skin) was covered with a cotton patch of 2.5 x 2.5 cm; the patch was soaked with the test substance and applied to the skin; no further data.
Duration of treatment / exposure:
1, 5, or 15 minutes (washing with Lutrol or 50 % aqueous Lutrol) or 20 h (unwashed)
Observation period:
Results were recorded each working day for up to 7 days (exceptions: see Table 2). The first scoring was conducted 24 h after initiation.
Number of animals:
2 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: After the reported exposure time the skin was washed (not after 20 h exposure).

SCORING SYSTEM:
BASF grading for redness and edema (see Table 1 below).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Reversibility:
other: no data for a 3rd animal
Remarks on result:
other: no data for a 3rd animal
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Reversibility:
other: no data for a 3rd animal
Remarks on result:
other: no data for a 3rd animal
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
other: mean 24h/72h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no data after 48 h; fine scales at the end of observation period
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
other: mean 24h/72h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: no data after 48 h
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #1
Time point:
other: mean 24h/72h
Score:
0
Max. score:
4
Reversibility:
other: no abnormality detected
Remarks on result:
other: no data after 48 h
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
animal #2
Time point:
other: 24h/72h
Score:
0
Max. score:
4
Reversibility:
other: no abnormality detected
Remarks on result:
other: no data after 48 h
Irritant / corrosive response data:
In the female rabbit no effects were detected after 1-15 minutes exposure except a slight reddening on the day of exposure, and concerning 15 minutes exposure a slight reddening also at the day after exposure; in the male rabbit also no effects were detected except a questionable reddening 1-3 days after exposure for 1-15 minutes.

Data after 20 h exposure are presented in the Table 2 below.
No edema was seen in any test animal. At all time points for scoring not more than a questionable reddening was detected, which was reversible after 7 days. One rabbit showed a fine scaling 7 days after application.
Other effects:
Body weight was not altered in both animals.
No further effects were reported.

Any other information on results incl. tables

 


Table 2: Skin erythema in 2 rabbits after dermal exposure to the undiluted test substance for 20 h







































Time after initiation of exposure



20 hours exposure; erythema in



Rabbit 1 (f)



Rabbit 2 (m)



24 h



1



1



48 h



no data



no data



72 h



1



1



4 days



1



1


 7 days fine scales 0

- Evaluation transformed to OECD-Draize scoring; no edema reported (no abnormality detected).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
DMAC was no skin irritant in rabbit. A slight transient (questionable) reddening of the skin was noted.
Executive summary:

In a study according to a BASF internal standard method comparable to OECD 404, two rabbits were dermally exposed to undiluted liquid test substance (ca. 1 mL) for 1, 5, 15 minutes or for 20 h to the back skin. The coverage was occlusive; the skin was washed after exposure (not after the exposure period of 20 h). Skin reaction was scored 24, 72, 96 h and 7 days after initiation.

The test substance had only slight skin irritant properties after an exposure period of 20 h. Questionable to slight reddening was found after 1-15 minutes of exposure, effects were reversible 48-96 h after exposure. After the 20 h exposure period no edema was seen in any test animal. At all time points for scoring not more than a questionable reddening (OECD score 1) was detected, which was reversible after 7 days. One rabbit showed a fine scaling 7 days after application. Therefore, the test substance was considered to be no skin irritant.