Registration Dossier
Registration Dossier
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EC number: 238-405-1 | CAS number: 14433-76-2
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-dimethyldecan-1-amide
- EC Number:
- 238-405-1
- EC Name:
- N,N-dimethyldecan-1-amide
- Cas Number:
- 14433-76-2
- Molecular formula:
- C12H25NO
- IUPAC Name:
- N,N-dimethyldecanamide
- Details on test material:
- - Name of test material (as cited in study report): SAT 970 419, Decansäuredimethylamid
- Chemical name: N,N-Dimethyldecan-1-amide
- Physical state: liquid
- Lot/batch No.: Ch. 1/96
- Expiration date of the lot/batch: June 1998
- Storage condition of test material: room temperature, darkness
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S
- Weight: 2.4-2.6kg
- Housing: animal room 2, filtered Air, ppo cages
- Diet (e.g. ad libitum): ad libitum / Altromin 2123 , Altromin , Lage , Germany
- Water (e.g. ad libitum): ad libitum (acified, HCl)
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 55±15%
- Air changes (per hr): 10times/h
- Photoperiod (hrs dark / hrs light):12h each
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml - Observation period (in vivo):
- 1h, 24h, 48h, 72h, 7d, 14d, 21d
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- corne opacity
- Basis:
- mean
- Remarks:
- three animals
- Time point:
- other: mean from 24h, 48h and 72h reading
- Score:
- <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days in 2 of 3 animals
- Remarks on result:
- other: When Fluorescein has been applied only the highest score for degree of corneal opacity from three readings are included
- Irritation parameter:
- iris score
- Remarks:
- iris lesion
- Basis:
- mean
- Remarks:
- three animals
- Time point:
- other: mean from 24h, 48h and 72h reading
- Score:
- <= 0
- Max. score:
- 2
- Remarks on result:
- other: normal reaction observed
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness of conjunctiva
- Basis:
- mean
- Remarks:
- three animals
- Time point:
- other: mean from 24h, 48h and 72h reading
- Score:
- <= 2.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days in 2 of 3 animals
- Irritation parameter:
- chemosis score
- Remarks:
- oedema of conjunctiva (chemosis)
- Basis:
- mean
- Remarks:
- three animals
- Time point:
- other: mean from 24h, 48h and 72h reading
- Score:
- <= 2.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days in 2 of 3 animals
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Eye irritant potential
- Executive summary:
The eye irritant effect of of the test substance (N,N-Dimethyldecan-1-amide) was investigated according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", 29.12.1992.
Three female albino rabbits were exposed to 0.1 ml of the test article in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 hours as well as 7, 14 and in two animals 21 days after dosing.
Moderate to severe signs of eye irritation were observed among the rabbits.
The following mean values, based on the results from the 24, 48 and 72 hour readings, were calculated:
Cornea opacity 1.0
Iris lesion 0.0
Redness of conjunctiva 2.6
Oedema of conjunctiva 2.8
After 14 days all animals showed hairless areas around the eye. Treatment related adverse eye reactions were fully reverse within 14 (1 animal) and 21 days.
Based on the result of this study the test substance is classified as eye irritant
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