Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand, Albino
Details on test animals or tissues and environmental conditions:
6 males
Acclimatization: at least 1 week unter test conditions without treatment
Body weight: approx. 4 kg
Number of animals/cage: 1
Diet: ad libitum (Altromin-Haltungsdiät 2023)
Water: tap water ad libitum
Room temperature: approx. 20-21°C
Relative humidity: approx. 45-55%
Light/dark cycle: 12/12 hours

Test system

Vehicle:
other: the test substance was suspended in carboxymethylcellulose (2%) and cremophor (0.5%)
Amount / concentration applied:
Concentration: 5 %
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Details on study design:
the eye was not rinsed, permanent contact

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 6, 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 6, 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 6, 24, 48, 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 6, 24, 48, 72 hours
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The 5% dilution of 3-Amino-2-methylamino-6-methoxy-pyridin has to be classified as non irritant or corrosive on the eyes.
Executive summary:

3-Amino-2-methylamino-6-methoxy-pyridin (Ro 730) was tested for primary eye irritation on rabbits by single application of 100 µl of a 5 % preparation of the substance in 2 % carboxymethylcellu­lose and 0.5 % cremophor and permanent contact. The pH-value was adjusted with undiluted ammonium at approx. 9. On the cornea, iris and conjunctivae were no reactions observed.

The 5% dilution of 3-Amino-2-methylamino-6-methoxy-pyridin has to be classified as non irritant or corrosive on the eyes.