Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10.11.98 - 12.01.99
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in GLP compliance and in accordance with an OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
AGEE 623 Amine
IUPAC Name:
AGEE 623 Amine
Constituent 2
Reference substance name:
108157-52-4
Cas Number:
108157-52-4
IUPAC Name:
108157-52-4
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): AGEE 623 Amine
- Physical state: dark liquid
- Analytical purity: 80.6 %
- Composition of test material, percentage of components: batch contains about 20% solvent
- Lot/batch No.: T29844
- Expiration date of the lot/batch: December 31, 1999
- Storage condition of test material: 4 °C, light protected, in the closed container
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg.
- Weight at study initiation: 3.2 kg, 4.8 kg, 3.7 kg
- Housing: Semi-barrier in air conditioned rooms
- Diet (e.g. ad libitum): Free access to Altromirr 2123 maintenance diet rabbit
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55± 10%
- Air changes (per hr): at least 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 : 12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
The test item was applied in a single dose in the conjunctival sac of one eye
of each animal after pulling the lower Iid away from the eyeball. The Iids
were then gently held together for about 1 second in order to prevent loss of
the material. The untreated eye served as control.
Observation period (in vivo):
24 h, 48 h and 72 hour
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: mean of 24h, 48h and 72h
Score:
2.11
Max. score:
2.67
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: mean of 24h, 48h and 72h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
A
Basis:
mean
Remarks:
3 animals
Time point:
other: mean of 24h, 48h and 72h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
B
Basis:
mean
Remarks:
3 animals
Time point:
other: mean of 24h, 48h and 72h
Score:
3.44
Max. score:
4
Reversibility:
not fully reversible within: 72h

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this irritation study it can be stated that the
test item caused marked irritation and corrosive effects to the eyes of albino
rabbits.
According to Directive 93/21 EEC the labelling of the test item (R 41 =risk
of serious darnage to eyes) is required.