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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
1986-04-08 to 1986-04-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD and GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

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:
1,3-dihydro-5-nitro-2H-benzimidazol-2-one
EC Number:
202-282-2
EC Name:
1,3-dihydro-5-nitro-2H-benzimidazol-2-one
Cas Number:
93-84-5
Molecular formula:
C7H5N3O3
IUPAC Name:
5-nitro-1,3-dihydro-2H-benzimidazol-2-one

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Polyethylene glycol (PEG 400)
Controls:
no
Amount / concentration applied:
- Amount of test substance applied: 500 mg Nitrolon in 0,33 ml Polyethylene glycol
Duration of treatment / exposure:
4 hrs
Observation period:
72 hrs
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0,5 to 1 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0,5 to 1 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritant / corrosive response data:
no signs were observed.
Other effects:
None, during entire study period

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on findings in this test Nitrolon TF is neither skin irritating nor skin corrosing.
Executive summary:

Nitrolon was tested for its potency as skin irritant according Guideline B.4 in the directive 84/449/EEC and its equivalent OECD Guideline 404 "acute dermal irritation/ corrosion", adopted 1981-05-12.

Following these protocols 500 mg substance, thickened with PEG 400 was applied to the shaved skin of New Zealand albino rabbit. After four hours exposure time the semiocclusive covering was removed and the application site carefully rinsed to remove adhesive substance. In the following 72 hours the animals were periodically examined for signs of skin irrittance and or corrosion.

Based on findings in this test Nitrolon TF is neither skin irritating nor skin corrosing.