Registration Dossier
Registration Dossier
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EC number: 203-838-7 | CAS number: 111-14-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Industrial Biotest Laboratory was found to use fraudulent practices in some of their studies and reports. Since these studies were performed before the implementation of Good Laboratory Practices, it is not possible to verify the scientific credibility of most of these studies.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- Heptanoic acid
- EC Number:
- 203-838-7
- EC Name:
- Heptanoic acid
- Cas Number:
- 111-14-8
- Molecular formula:
- C7H14O2
- IUPAC Name:
- heptanoic acid
- Details on test material:
- substance: heptanoic acid (SN-1767)
physical state : a clear, colorless liquid.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Form administered : instillation (0.1 ml)
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test material was instilled into the conjunctival sac of the right eye of each rabbit. The left eye of each animal served as a control. At each scoring interval the cornea, iris, and palpebral conjunctiva were examined and graded for irritation and injury according to a standard scoring system. The maximum possible score at any one examination and scoring period is 110 points, which indicates maximal irritation and damage to all three ocular tissues. Zero score indicates no irritation.
Results and discussion
In vivo
Results
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 24-48-72 hours (mean)
- Score:
- 72.1
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
Applicant's summary and conclusion
- Conclusions:
- Heptanoic acid is extremely irritating.
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