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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
AATI
IUPAC Name:
AATI
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact skin
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
dose: 0,5g prepared as a paste with 0,23g of water per animal
Duration of treatment / exposure:
exposure: 4h
Observation period:
24, 48 and 72h
Number of animals:
6 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48h
Score:
ca. 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48H
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72H
Score:
ca. 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72H
Score:
ca. 0
Irritant / corrosive response data:
From the results obtained under the experimental conditions employed, application of this test article to the rabbit skin did not provoke any noticeable irritation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
From the results obtained under the experimental conditions employed, application of this test article to the rabbit skin did not provoke any noticeable irritation.
Executive summary:

PROTOCOL

The test article was applied at the dose level of 0.5g prepared as a paste with 0.23g of water for injection per animal, under a semi-occlusive bandage for 4 hours, to the intact skin of 6 New Zealand White male rabbits.

The cutaneous examinations were performed, for erythema and oedema, according to a numerical scale, 1, 24 (Day1), 48 and 72 hours after removal of the bandage.

Mean values were calculated from the evaluation of the cutaneous lesions performed in all the rabbits examined at 24, 48 and 72 hours.

RESULTS AND CONCLUSION

  Mean values for cutaneous irritation were as follows:
   erythema  oedema
 at 24 hours 0.00   0.00
 at 48 hours  0.00  0.00
 at 72 hours  0.00  0.00

 

i.e. a global average (24 hours + 48 hours + 72 hours) of 0.00 for erythema and of 0.00 for oedema.

From the results obtained under the experimental conditions employed, application of this test article to the rabbit skin did not provoke any noticeable irritation.

According to the guide of the labelling of dangerous substances published in the Official Journal of the European Communities (EEC Directive 93/21), this test article can be labelled as follows:

-Symbol: nothing

-Risk sentence: nothing.