Registration Dossier
Registration Dossier
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EC number: 271-832-1 | CAS number: 68609-68-7 The complex combination of products produced by the distillation of products from a 2-ethyl-1-hexanol manufacturing process. It consists predominantly of organic compounds such as alcohols, aldehydes, esters, carboxylic acids and acetals having carbon numbers predominantly in the range of C4 through C16 and boiling in the range of 150°C to 308°C (302°F to 586°F).
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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:
- 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues
- EC Number:
- 271-832-1
- EC Name:
- 1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues
- Cas Number:
- 68609-68-7
- Molecular formula:
- UVCB, not applicable, see section 1.2 for information on constituents
- IUPAC Name:
- 2,4-diethyl-3-propylpentane-1,5-diol; 2,4-diethyloctan-1-ol; 2-ethylhexan-1-ol; 2-ethylhexane-1,3-diol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: approximately 12-16 weeks old
- Weight at study initiation: 2.51-2.80 kg
- Housing: individually, in suspended metal cages
- Diet: Rabbit Diet (AW Tindall Limited, Holbeach, Lincolnshire, U.K.), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-20 °C
- Humidity: 60-68 %
- Air changes: approximately 10 changes/hour
- Photoperiod: 12 hours dark / 12 hours light
IN-LIFE DATES: From: 08-Oct-1985 To: 11-Oct-1985
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- Single intraocular application
- Observation period (in vivo):
- 72 hours (terminated as no reactions were apparent)
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- SCORING SYSTEM: Draize (1959) scale for scoring ocular irritation. Using the numerical data obtained a modified version of the system described by Kay & Calandra (1962) was used to classify the ocular irritation potential of the test material.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 13
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 6
- Max. score:
- 110
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 11
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 10
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: group mean score
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: group mean score
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: group mean score
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: total score for conjunctivae, iris and cornea
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: group mean score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
Any other information on results incl. tables
No evidence of corneal damage was noted throughout the 72-hour study period. Iridial inflammation was apparent in 2/3 rabbits at the 1-hour reading only. Slight conjunctivitis identified by redness (grade 2) and swelling (grades 1-2) was noted in 3/3 rabbits at the 1-hour reading. The reactions had resolved completely by the 24-hour (1/3 rabbits) or the 48-hour observation (2/3 rabbits). In addition, 0/3 rabbits showed evidence of positive ocular irritation.
Applicant's summary and conclusion
- Executive summary:
In a primary eye irritation study (Jones & Collier, 1985), 0.1 mL of undiluted ZD 8 Gewaschen was instilled into the conjunctival sac of the right eye of young adult New Zealand White rabbits. Animals then were observed for 72 hours following treatment. Irritation was scored by the method of Draize (1959) and the test item was classified for its ocular irritation potential according to Kay & Calandra (1962, modified). The treatment resulted in a maximum mean score of 10 and the test item was classified as a minimal irritant (class 3 on a scale of 1 to 8).
In this study, ZD 8 Gewaschen was a minimal irritant to the rabbit eye.
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