Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP 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 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye 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 / tissue source

Species:
rabbit
Strain:
other: HSDIF: NZW
Details on test animals or tissues and environmental conditions:
Animal supplier: Harlan Winkelmann GmbH (Interfauna - United Kingdom)
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

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
0.1 ml bulk volume (about 41 mg of the comminuted test substance)
Duration of treatment / exposure:
Exposure: 24 hours
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (2 females, 1 male)
Details on study design:
Application: Single application to the conjunctival sac of the right eyelid; the substance was washed out with tap water about 24 hours after application (before 24 hour reading).
Readings: 1, 24, 48, 72 hours after application.
Mortality: A check for any dead or moribund animals was made twice each workday and once on saturdays, sundays and on public holidays.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h, 48h and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h, 48h and 72h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h, 48h and 72h
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24h, 48h and 72h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24h, 48h and 72h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24h, 48h and 72h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h, 48h and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Applicant's summary and conclusion

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