Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test substance: MGDN
Chemical name: Propanenitrile, 2- [Bis (Cyanomethyl) - Amino] -, (+-)
Substance number: 96/83
Batch number: GRE 3038/F 535
Degreee of purity/content: 97.9% (HPLC)
Date of manufacturing: September 09 - 11, 1994
Physical state/appearance: powder, beige.
Storage conitions: Room temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animal supplier: Dr. K. Thomae GmbH, Biberach, FRG
Age: Young adult animals.
Identification: Ear Tattoo.
Room Temperature/relative humidity: Animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20-24°C for temperature and of 30-70% for relative humidity. There were no deviations from these ranges which influenced the results of the study.
Day/Night rhythm: 12h / 12h (6.00 a.m. - 6.00 p.m./6.00 p.m. - 6.00 a.m.)
Type of cage: stainless steel wire mesh cages with grating.
Floor area: 3000 cm2.
No. of animals per cage: single housing.
Drinking water: about 250 ml tap water per animal per day.
Diet: Kliba-Labordiät 341, Klingentalmuehle AG Kaiseraugst, Switzerland. About 130 g per animal per day.
Acclimatization period: at least one week.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
other: test substance moistened with aqua bidest
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
Exposure: 4 hours.
Observation period:
72 hours
Number of animals:
3 female
Details on study design:
At least 24 hours before the test, the fur was removed by clipping the dorsal part of the trunk of the animal(s). Only animals with healthy intact skin have been used. The test substance was removed at the end of the exposure period with Lutrol and Lutrol/Water (1:1).
Application site: upper third of back or flanks.
Readings: 1h, 24h, 48h, and 72h.
Mortality: A check for any dead or moribund animal was made twice each workday and once on saturdays, sundays and on public holidays.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24h, 48h and 72h
Score:
0.2
Reversibility:
fully reversible within: at least 72 h
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h, 48h and 72h
Score:
0
Reversibility:
other: no effects
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h, 48h and 72h
Score:
0.7
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24h, 48h and 72h
Score:
0
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h, 48h and 72h
Score:
0
Reversibility:
other: no effects
Remarks on result:
other: Edema score of individual animals was 0 at 24, 48 and 72 h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS