Registration Dossier
Registration Dossier
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EC number: 263-157-6 | CAS number: 61790-66-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 23, 1990 to February 14, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)
- EC Number:
- 271-653-9
- EC Name:
- Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)
- Cas Number:
- 68603-38-3
- Molecular formula:
- The alkyl chain length of the amide ranges between 16 and 18 carbon atoms
- IUPAC Name:
- Amides, C16-18 (even numbered) and C18-unsatd., N, N-bis(hydroxyethyl)
- Reference substance name:
- Glycerol
- EC Number:
- 200-289-5
- EC Name:
- Glycerol
- Cas Number:
- 56-81-5
- Molecular formula:
- C3H8O3
- IUPAC Name:
- glycerol
- Reference substance name:
- 2,2'-iminodiethanol
- EC Number:
- 203-868-0
- EC Name:
- 2,2'-iminodiethanol
- Cas Number:
- 111-42-2
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2,2’-iminodiethanol
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small White Russian Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.3 - 2.5 kg
- Housing: Single animals in steel cages
- Diet (e.g. ad libitum): K4 diet for rabbits, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): yes
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23-01-1990 To: 09-02-1990
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Right eye of each animal was untreated and served as control
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 17 d
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Not applicable
- Score:
- 34.9
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Moderately irritating
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 d
- Remarks on result:
- other: 2/3 animals showed corneal opacity, reversible within 10 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.56
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 d
- Remarks on result:
- other: 2/3 animals showed redness and circumcorneal injection, reversible within 10 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13d
- Remarks on result:
- other: 3/3 animals showed light swellingof the conjunctivae, reversible within 13 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.77
- Max. score:
- 3
- Reversibility:
- fully reversible within: 13 d
- Remarks on result:
- other: 3/3 animals showed strong erythema, reversible within 13 days
- Other effects:
- No details provided.
Any other information on results incl. tables
None.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the study conditions, the test substance was considered irritating to rabbit eyes.
- Executive summary:
A study was conducted to determine the irritation potential of the test substance, C16-18 and C18-unsatd. DEA, to rabbit eyes according to OECD Guideline 405. The substance was applied neat to the left eye of three rabbits; the right eye served as untreated control. Animals were then observed for 17 d. Two out of three animals showed opacity of the cornea as well as slight corneal reddening and circum-corneal injection. These effects were reversible within 10 d. In all animals, moderate to strong erythema and slight swelling of the conjunctivae were noted. This was reversible within 13 d. The overall irritation index was 34.9/110. Under the study conditions, the test substance was considered to be irritating to rabbit eyes (Mürmann, 1990).
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