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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Mar - 09 Mar 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
adopted in 1984
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
not specified
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ziram
EC Number:
205-288-3
EC Name:
Ziram
Cas Number:
137-30-4
Molecular formula:
C6H12N2S4Zn
IUPAC Name:
ziram

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: A. Smith, Surrey, UK
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: Animals were individually housed in metal cages with perforated floors.
- Diet: SDS standard rabbits diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: rabbits were acclimated to the laboratory environment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 19
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL destilled water

NEGATIVE CONTROL
No negative control was used.

POSITIVE CONTROL
No positive control was used.
Duration of treatment / exposure:
4 h
Observation period:
4 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm²
- Type of wrap if used: Each treatment site was occluded with elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: After exposure period, the treatment sides were washed using water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Throughout the study, the rabbits were observed for clinical signs once daily. Examination of the treated skin and observations for erythema, eschar and oedema formation were performed on Day1 (approximately 30 min after removal of the patches) and on Days 2, 3 and 4.

SCORING SYSTEM:
- Method of calculation: According to OECD guideline 404, equivalent to the Draize scoring system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No erythema, eschar, oedema or other skin irritations were observed.
Other effects:
Clinical signs:
There were no clinical signs in any of the animals.

Applicant's summary and conclusion

Interpretation of results:
other: According to the classification criteria of the CLP Regulation (EU) No. 1272/2008, no classification is required.
Conclusions:
The study is in accordance with EPA OPP 81-5 (Acute Dermal Irritation) and GLP. The skin irritation potential of the test substance was investigated following a 4 h exposure to New Zealand White rabbits. Under the conditions chosen, a single semi-occlusive application of the test substance to intact rabbit skin for 4 h elicited no dermal irritation. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for skin irritation is required.