Registration Dossier

Toxicological information

Eye irritation

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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:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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.

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.