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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive 92/69, Annex V - Method B4 and OECD No. 404
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: closely clipped
Vehicle:
other: The test substance was applied undiluted.
Controls:
no
Amount / concentration applied:
500mg
Duration of treatment / exposure:
4 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 1, 24, 48, and 72 h
Score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
1
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
1
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 1, 24, 48 and 72 h
Score:
0
Reversibility:
no data
Irritant / corrosive response data:
A very slight erythema was noted in one animal from day 1 and was reversible by day 7. A very slight erythema was observed in the two other animals from day 1 or 2 and was reversible by day 4 or day 6, respectively.
Other effects:
Dryness of the skin was recorded over 24, 48 and 72 h for each aninal at day 5 and was absent by day 9.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under our experimental conditions, the test substance Pseudo Kharismal Step 1 is slightly irritating when applied topically to rabbits. However, according to the classifications criteria laid down in Commission Directive 93/21/EEC the test substance should not be classified as irritating to the skin.
Executive summary:

Under our experimental conditions, the test substance Pseudo Kharismal Step 1 is slightly irritating when applied topically to rabbits. However, according to the classifications criteria laid down in Commission Directive 93/21/EEC the test substance should not be classified as irritating to the skin.