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Registration Dossier
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EC number: 205-855-5 | CAS number: 156-43-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No provided data on GLP compliance.
Data source
Reference
- Reference Type:
- publication
- Title:
- EVALUATION OF THE OCULAR-IRRITATION POTENTIAL OF 56 COMPOUNDS
- Author:
- GUILLOT JP, GONNET JF,CLEMENT C, CAILLARD L, TRUHAUT R
- Year:
- 1 982
- Bibliographic source:
- Fd Chem. Toxic. Vol. 20. pp. 573 to 582, 1982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Journal Officiel 21 April 1971, p. 3862; ibid 5 June 1973, p. 3953) (official method approved by the French authorities for the testing of cosmetics and toiletries)
- Qualifier:
- according to guideline
- Guideline:
- other: AFNOR (Association Francaise de Normalisation, 1982)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD (Organisation for Economic Co-operation and Development, 1979)
- Deviations:
- no
- Principles of method if other than guideline:
- This paper describes the results obtained on 56 substances tested at IFT (Institut François de Toxicologie) in a manner designed to permit a comparison between three of the available methods.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-phenetidine
- EC Number:
- 205-855-5
- EC Name:
- p-phenetidine
- Cas Number:
- 156-43-4
- Molecular formula:
- C8H11NO
- IUPAC Name:
- 4-ethoxyaniline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Roucher SA, Couhe
- Weight at study initiation: 2-5 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- First and second tests: one application
Third test: only rinsing - Observation period (in vivo):
- First test: observations were recorded at 1 h and I, 2, 3, 4 and 7 days after instillation and, in cases where lesions persisted, also at later stages.
- Number of animals or in vitro replicates:
- groups of 6
- Details on study design:
- First test:
6 rabbits: 0.1 ml was instilled and observations were recorded at 1 h and I, 2, 3, 4 and 7 days after instillation and, in cases where lesions persisted, also at later stages.
Second and third tests:
Test materials showing any degree of irritancy more severe than that classified as slightly irritant (see below) in this first test were similarly instilled into another group of six rabbits, and the eyeball and related structures were rinsed 30 sec after the instillation. If the material was still found to be irritant, a third test was run with rinsing after 4 sec.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in the second and third tests
SCORING SYSTEM: since the Cosmetic and OECD protocols specify no numerical system for the scoring and interpretation of results, a scoring system based on the AFNOR recommendations was used throughout, with modifica¬tions where appropriate to enable direct comparisons between the protocols to be made.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: AOI: acute ocular irritation index
- Basis:
- mean
- Score:
- 41.67
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: without rinsing
- Irritation parameter:
- other: acute ocular irritation index
- Basis:
- mean
- Score:
- 34.33
- Remarks on result:
- other: rinsing in 30 seconds
- Irritation parameter:
- other: acute ocular irritation index
- Basis:
- mean
- Score:
- 13.33
- Remarks on result:
- other: rinsing in 4 seconds
- Irritation parameter:
- other: MOI: mean ocular irritation index
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0.33
- Remarks on result:
- other: without rinsing
- Irritation parameter:
- other: MOI: mean ocular irritation index
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 6.33
- Remarks on result:
- other: rinsing in 30 seconds
- Irritation parameter:
- other: MOI: mean ocular irritation index
- Basis:
- mean
- Time point:
- other: 2 days
- Score:
- 0
- Remarks on result:
- other: rinsing in 4 seconds
- Irritation parameter:
- other: IOI: individual ocular irritation index
- Basis:
- mean
- Time point:
- other: day 7
- Max. score:
- 15
- Remarks on result:
- other: without rinsing
- Irritation parameter:
- other: IOI: individual ocular irritation index
- Basis:
- mean
- Time point:
- other: day 7
- Max. score:
- 15
- Remarks on result:
- other: rinsing in 30 seconds
- Irritant / corrosive response data:
- Without rinsing: very irritant
Rinsing in 30 seconds: very irritant
Rinsing in 4 seconds: slightly irritant
Any other information on results incl. tables
No more available data on the results.
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is considered as very irritant based on the results of the study.
- Executive summary:
The ocular irritancy of 56 chemicals was tested in the rabbit eye, with and without rinsing, using a procedure that complied with the main requirements of three protocols, namely those proposed by the Association Francaise de Normalisation (AFNOR) in 1982 and by the Organisation for Economic Cooperation and Development in 1979 for the testing of chemicals and that published by the French authorities(Journal Officiel21 April 1971, p. 3862;ibid5 June 1973, p. 3953) for the testing of cosmetics and toiletries. The results obtained were used to establish the extent to which the assessment of a chemical's irritation potential was affected by the differences between the three protocols in respect of the observation times prescribed, the inclusion and timing of rinsing, the number of animals used and the interpretation procedure. Conclusions were also drawn about the influence of the physical state and pH of a material on its potential irritancy and about the level of irritancy that necessitates the use of eye protection.
The experience has shown that the various ocular irritation indices are not a particularly helpful guide in themselves; a graduated scale of irritancy taking into account both these indices and the reversibility of the lesions seems a preferable basis for the interpretation of results.
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