Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 March 1994 to 25 March 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
(1984)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
Version / remarks:
(1989)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: JMAFF 59 NohSan No. 4200 (Guidance on toxicology study data for application of agriculture chemical registration) (1985)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
603-373-3
EC Number:
603-373-3
Cas Number:
129909-90-6
Molecular formula:
C10H19N5O2
IUPAC Name:
603-373-3
Constituent 2
Reference substance name:
Technical Grade MKH 3586
IUPAC Name:
Technical Grade MKH 3586
Details on test material:
- Name of test material (as cited in study report): Technical Grade MKH 3586
- Physical state: Beige powder
- Analytical purity: 97.8 - 98.2%
- Purity test date: 17 Jun 1994
- Lot/batch No.: 17004/93
- Expiration date of the lot/batch: 6 months from date of purity testing

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
30-60 minutes, 24, 48 and 72 hrs post removal of the patch
Number of animals:
6 males/dose group

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: All time points
Score:
ca. 0
Max. score:
0
Reversibility:
other: No erythema or oedema was present

Any other information on results incl. tables

OBSERVATIONS:

Clinical / skin:

No clinical signs of toxicity or other lesions were observed. No erythema or oedema were evident at the dose site of any animal following exposure, therefore the result of the PII of 0.0 was calculated.

 

Mortality:

All animals survived to the end of the experimental phase.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test material returned a PII of 0.0 and is therefore considered non-irritating.
Executive summary:

In a primary dermal irritation study, 6 young adult male New Zealand rabbits were exposedviathe dermal route to 0.5 mL of MKH 3586/animal. The test material was administered semi occluded as supplied (moistened with a small amount of water) for 4 hours to a clipped area of intact skin. Animals were then observed up to 72 hours post end of treatment. Irritation was scored using the primary irritation index grading scheme.

 

No clinical signs of toxicity or other lesions were observed. No erythema or oedema were evident at the dose site of any animal following exposure

 

Under the conditions of this study, the test material returned a PII of 0.0 and is therefore considered non-irritating.