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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:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Annex V to Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, published in the Seventeenth Adaption, commission Directive 92/69/EEC, OJEC L383A, 124-127, 1992. (B.4: Acute toxicity (skin irritation).

United States Environmental Protection Agency, Health Effects Test Guidelines, OPPTS 870.2500 (1998), Acute Dermal Irritation
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine
EC Number:
700-475-0
Cas Number:
145783-14-8
Molecular formula:
C7H7Cl2N3O2S
IUPAC Name:
4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0,5 ml
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
Time point:
other: 1 h, 1, 2, 3, 4, 7, 10 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 d
Remarks on result:
other: Very slight erythmea
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h, 1, 2, 3, 4, 7, 10 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 17 d
Remarks on result:
other: Very slight erythmea
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h, 1, 2, 3, 4, 7, 10 days
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 17 d
Remarks on result:
other: Very slight erythmea
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h, 24 h, 48 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Moderate edema
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 3, 4 days
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
other: Slight edema
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h, 24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
other: Moderate edema
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 2, 3, 4, 7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
other: Very slight edema
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
other: Severe edema
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 48 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
other: Moderate edema
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 3, 4 d
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 10 d
Remarks on result:
other: Slight edema
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10d
Remarks on result:
other: Very slight edema
Irritant / corrosive response data:
Additional signs of irritation were seen in all animals and consisted of cracking, desquamation, scabbing, thickening, wrinkling, hardening, wet sores and areas of new skin. All signs of irritation had resolved in two animals within 14 or 28 days but skin irritation was still apparent in the remaining animal after 35 days.
Other effects:
Macroscopic abnormalities consisted of redness and scabs in treated skin. Microscopic examination showed marked damage, with slight hyperkeratosis, moderate acanthosis, slight inflammatory cell infiltration, slight focal epithelial necrosis, marked hair follicle loss and sub-epithelial fibrosis.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classified as corrosive (Skin Corr 1B/C; R34)