Registration Dossier
Registration Dossier
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EC number: 221-975-0 | CAS number: 3302-10-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-06-24 to 1986-07-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was performed according to OECD guideline 405
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,5,5-trimethylhexanoic acid
- EC Number:
- 221-975-0
- EC Name:
- 3,5,5-trimethylhexanoic acid
- Cas Number:
- 3302-10-1
- Molecular formula:
- C9H18O2
- IUPAC Name:
- 3,5,5-trimethylhexanoic acid
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): Isononansäure
Charge 1144 from 1985-11-19, not specified isomer mixture, purity 99,7% with 0.25-0.3% main impurities
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small White Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- - Source: Thomae, Biberach, Germany
- Weight at study initiation: 1.97-2.1 kg
- Housing: individual in cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Spezialfutter, Soest, Germany, ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15-fold
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 1, 24, 48 and 72 h as well as 6, 8, 10, 13, 17 and 21 days post application
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- 0.1 ml of the test substance was applied into the conjunctival sac of one eye of each animal, the other eye served as control. The exposed eye was treated with fluorescein solution to detect cornea damage and afterwards rinsed with warm physiological saline.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 h - 21 days
- Score:
- 41.84
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: individual scores (24-48-72 h): 2.0, 1.67, 1.67, calculated from the data in the attached document
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: individual scores (24-48-72 h): 1.0, 1.0, 1.0, calculated from the data in the attached document
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: individual scores (24-48-72 h): 3.0, 3.0, 3.0, calculated from the data in the attached document
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: individual scores (24-48-72 h): 1.0, 1.0, 1.0, calculated from the data in the attached document
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test substance was irritating to the eye. As lesions were still persisting at the end of the observation period, the results have to be considered as "severely irritating to the eye".
- Executive summary:
Effects on eyes have been assessed in a test according to OECD TG 405. The application of undiluted test substance to the eyes of rabbits produced an eye irritation to be considered as severe (effects still present at the end of the observation time; overall irritation score: 41.48/110, cornea score:1.78/4, iris score: 1/2, conjunctivae score: 3.0/3, chemosis score: 1.0/4) (Hüls AG, 1986).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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