Registration Dossier
Registration Dossier
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EC number: 939-498-8 | CAS number: -
Eye irritation
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: Guideline study (OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted april 24th, 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- Molecular formula:
- Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- IUPAC Name:
- Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- Details on test material:
- - Name of test material (as cited in study report): octadecoic acid,9,10,-dihydroxy-mono-ammonium salt due to characterisation renamed to Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia
- Physical state: yellowish, pasty
- Analytical purity: 50%
- Lot/batch No.: 59/0
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: breeder Thomae, Biberach/FRG
- Age at study initiation: 14 - 23 months
- Weight at study initiation: approx. 2610 g
- Housing: single holding, cage: Heinkel, 7343, Kuchen/FRG
- Diet (e.g. ad libitum): Altromin-Haltungsdiät 2023, Altromin GmbH, Lage/FRG, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: minimum of 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 20 - 25°C
- Humidity (%): approx. 45 - 70 %
- Photoperiod (hrs dark / hrs light): artificial day/night interval (12 hours)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
reading time points: 1, 24, 48, 72 hours, 7, 14, 21 days - Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): solid rinsing with warm water
- Time after start of exposure: 24 hours
SCORING SYSTEM: all observations were assessed according to the council directive 84/449/EEC [Off. Journal Europ. Commun. L 251/112, 1984]
TOOL USED TO ASSESS SCORE: fluorescein staining following rinsing
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1 and animal #2
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: only reversible for animal #1 in 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: bloody infiltrate after 14 days and 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: bloody infiltrate at 14 days up to 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: bloody infiltrate after 1 hour up to 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean over 24 - 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The symptoms of the conjunctiva were mild to strong at all three rabbits up to 7 days. One animal became healthy after 14 days. Two animals showed bloody infiltrations up to 21 days, one of them furthermore effects on the cornea, the iris and the conjunctiva.
- Other effects:
- Exsudation was observed for all 3 animals as early as 1 hour after application, which was reversible for animal #1 and #3 after 7 days and animal #2 after 21 days.
Any other information on results incl. tables
DSD: Xi, R41 - Risk of serious damage to eyes
CLP: Category 1
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:
- According to the test conditions employed, the results indicate that the test substance must be classified as "strongly irritating" to mucous membranes.
- Executive summary:
The test substance was tested for acute irritation effects on eyes of three rabbits (Kleinrussen, Chbb:HM) with a single dose of 0.1 g per conjunctival sac and a duration of exposure of 24 hours. [Method: Off. J. Europ. Commun. L251, 27, 109 -112 (1984) and OECD-Guidelines for Testing of Chemicals, No. 405]. Mild up to strong erythema and edema were observed.
Weak up to moderate opacity was observed on the cornea.
Additionally, mild symptoms on the iris were observed.
At two animals all relevant symptoms disappeared totally within 14 days, at one animal the symptoms did not disappear within 21 days.
According to the test conditions the test substance has classified to be "strongly irritating" to mucous membranes.
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