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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The method used permits the measurement of pH and acidic/alkaline reserve of all types of chemicals, under conditions which reproduce possible hydrolysis, in order to identify chemicals potentially corrosive to the eye.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Heptylamine
EC Number:
203-895-8
EC Name:
Heptylamine
Cas Number:
111-68-2
Molecular formula:
C7H17N
IUPAC Name:
heptan-1-amine
Details on test material:
- Name : n-heptylamine
- Purity: commertial grade

Test system

Details on study design:
No guideline is available to assess the acidic/alkaline reserve of substances. However, the updated versions of guidelines 404 and 405 include a Supplement that recommends the sequential testing strategy (including pH and acidic/alkaline reserve measurements) prior to undertaking the in vivo tests for corrosion/irritation of the substance.
The method used in the present study to assess the pH and the acidic/alkaline reserve was described in the following references:
- JF. Regnier and C. Imbert (1992). Contributions of physical-chemical properties to the evaluation of ocular irritation. Third SPTC Meeting, ATLA 20, 457-465.
- V. Froment (1993). Stage report, Elf Atochem SA. Evaluation du potentiel corrosif des produits chimiques par deux méthodes alternatives au test de Draize : Corrositex, Méthode physico-chimique.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: pH
Value:
11.7
Remarks on result:
other: Considered to be potentially corrosive, based on pH and alkaline reserve measurements
Irritation parameter:
other: alcaline reserve
Value:
1.25
Irritation parameter:
other: Index
Value:
12.9

Applicant's summary and conclusion

Interpretation of results:
other: Severely irritanting
Conclusions:
N-heptylamine is considered as potentially severely irritanting to the eye.
Executive summary:

To evaluate the potential corrosivity for the eye of n-heptylamine, the pH and acidic/alkaline reserve was measured according to the method described by Regnier and Imbert (ATLA, 1992, 20, 457-465) and Froment (Arkema unpublished data, 1993). Under the test conditions, the results are as follow:

Test item

pH

log R (acidic/alkaline reserve

Physical-chemical index (I)

I = pH + log R, for pH =7

I = (14 -pH) + log R, for pH < 7 

N-heptylamine

11.7

1.25

12.9

According to the method, a substance is considered as potentially corrosive to the eye if at least 2 of the 3 following criteria are fulfilled:

pH= 2.5 or pH =9.5; log R = 0 and /or I= 9.

N-heptylamine is considered as potentially severely irritanting to the eye.