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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:
1986-04-22 to 1986-04-25
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:
2-hydroxybenzimidazole
EC Number:
210-412-4
EC Name:
2-hydroxybenzimidazole
Cas Number:
615-16-7
Molecular formula:
C7H6N2O
IUPAC Name:
2-hydroxybenzimidazole

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Polyethylenglycol 400
Controls:
no
Amount / concentration applied:
500 mg Benzimidazolon in 0.35 ml Polyethylenglycol
Duration of treatment / exposure:
4 hrs
Observation period:
total of 72 hrs
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30-60 min
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30 - 60 min
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30 - 60 min
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal: each #1, 2 and 3
Time point:
other: 24 hrs, 48 hrs, 72 hrs
Score:
0
Irritation parameter:
edema score
Basis:
animal: each #1, 2 and 3
Time point:
other: 30- 60 min, 24 hrs, 48 hrs, 72 hrs
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
With reference to the present study the test item is neither a skin irritant nor corrosive to skin.
Executive summary:

With reference to the present study the test item is neither a skin irritant nor corrosive to skin.

The judgement is based on the mean (of 24, 48 and 72 h) dermal irritation scores tabulated below:

Erythema (animal # 1/2/3): 0.0/0.0/0.0

Oedema (animal # 1/2/3): 0.0/0.0/0.0