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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-06-06 to 1989-06-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD guideline 405 and in compliance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Genamin 18R 100 D

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breed
- Weight at study initiation: 2.29 kg
- Age at study initiation: ca. 3 - 5 months
- Housing: fully air-conditioned rooms, cages on their own
- Diet (e.g. ad libitum): Altromin 2113 (supplied by Altromin GmbH Lage/Lippe)ad libitum and hey (ca. 15 g daily)
- Water (e.g. ad libitum): deionized, chlorinated water, ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3°C
- Humidity (%): 50 +-20 %
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL Genamin 18 R 100 D
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
1, 24, 48, 72 hrs, 7 days
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm (37°C) physiological saline solution
- Time after start of exposure: 24 hrs

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
0.01 % fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
corneal vascularisation after 7 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
1
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean
Time point:
other: 24h / 48h / 72h
Score:
3
Max. score:
3
Reversibility:
not reversible

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Irritating [Xi] - R41- Risk of serious damage to eyes
Executive summary:

In an OECD TG 405 study, 0.1 ml of the test material Genamin 18 R 100 D (octadecylamine), a whitish waxy solid (purity approximately 100%), was applied to the eye of one New Zealand White rabbit. 24 hours after treatment, the eye was washed with 0.9% tepid NaCl solution. From 1 hour on, the conjunctiva showed red beefy discoloration and pronounced chemosis. Iris and cornea showed lesions. Additionally, a clear colourless to whitish-slimy discharge was noted. Due to progressed vascularisation of the eye, the study was terminated after 7 days. Mean Draize scores for conjunctiva redness and chemosis at 24, 48 and 72 hours were 3.0, 3.0 and 3.0. Mean scores for iris were 1.0, 1.0 and 1.0 and for cornea opacity were 2.0, 2.0 and 2.0 (same time points)

According to the results of the study the test substance Genamin 18 R 100 D has to be regarded as irritating (Xi – R41- Risk of serious damage to eyes) in compliance with the criteria laid down in 83/467/EWG.