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Registration Dossier
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EC number: 310-079-6 | CAS number: 102242-48-8 The complex residue resulting from the vacuum distillation of C6-24 and C6-24 unsatd. fatty alcohols which is derived from hydrogenation of C6-24 and C6-24 unsatd. fatty acids methyl esters. It consists predominantly of satd. and unsatd. fatty alcohols having carbon numbers greater than C18, dimerization products, and long chain esters having carbon numbers greater than C32 and boils at > 250°C (482°F) at 10 torr.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 27 - August 06, 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Alcohols, C6-24 and C6-24-unsatd., distn. residues
- EC Number:
- 310-079-6
- EC Name:
- Alcohols, C6-24 and C6-24-unsatd., distn. residues
- Cas Number:
- 102242-48-8
- Molecular formula:
- Not available due to the complexity of the substance
- IUPAC Name:
- Alcohols, C6-24 and C6-24-unsatd. even numbered, distn. residues
- Details on test material:
- - Name of test material (as cited in study report): Pernil RU, Espum EGA 213
- Chemical designation: 18:1 fatty alkohol, unsaturated, distillation residue
- Physical state: brown liquid
- Analytical purity: 100%
- Lot/batch No.: Charge of laboratory, no batch number given
- Expiration date: December 31, 1995
- Stability: yes
- Storage: at room temperature
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: Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 18 months
- Weight at study initiation: approx. 2.85 kg
- Housing: individually
- Diet: Ssniff rabbit diet K4 (Ssniff GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 8 and 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes: 8/h
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h
- Other: music was offered during light hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- An amount of 0.1 mL of unchanged test material was applied into the conjunctival sac of the right eye of each test animal.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
Reading time points: 1, 24, 48, 72 h - Number of animals or in vitro replicates:
- As recommended by the guideline, first one animal was treated, and depending on the severity of the results, two further animals were treated analogically one week later.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (tap water)
- Time after start of exposure: 24 h
SCORING SYSTEM
The assessment of the findings was based on the Draize Scoring System, as recommended by the current testing guideline (Draize JH, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In Dermal Toxicity, 46-59, 1959).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2 and 3, respectively
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: none of the 3 animals showed corneal opacity
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 2 and 3, respectively
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: none of the 3 animals showed effects in the iris
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1 and 2, respectively
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: in 2/3 animals, no conjunctival redness was observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: the third animal showed a transient redness of the conjunctiva graded 1 at reading time point 24 h only
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 2 and 3, respectively
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Remarks on result:
- other: none of the 3 animals showed chemosis
- Irritant / corrosive response data:
- Following treatment, the first test animal displayed erythema grade 1 accompanied by discharge grade 2 at reading time point 1 h only. The second animal showed no eye reaction at all, whereas the third one had discharge grade 2 at reading time point 1 h, and conjunctival redness at 24 h.
- Other effects:
- In two cases, transient discharge grade 2 was noticed at reading time point 1 h only.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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