Registration Dossier
Registration Dossier
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EC number: 214-230-6 | CAS number: 1115-70-4
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Individual scores are not provided
- Justification for type of information:
- Comperative study using the AFNOR protocol in comparison to the OECD protocol.
References:
French authorities for the testing of cosmetics and toiletries (Journal Officiel de la Republique Francaise, 1971 & 1973
Association Francaise de Normalisation (1982). Evaluation de I’lrritation et/au de la Corrosion Oculaires, chez le Lapin. AFNOR (Project): TD3-B dot. 37.
Organisation for Economic Co-operation and Development (1979). OECD Short-term and Long-term Toxicology Groups, Final Report: Acute Eye Irritation/Corrosivity. 31 December, p. 40.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1979
- Qualifier:
- according to guideline
- Guideline:
- other: Association Francaise de Normalisation (1982). Evaluation de I’lrritation et/au de la Corrosion Oculaires, chez le Lapin. AFNOR (Project): TD3-B doc. 37.
- Version / remarks:
- 1982
- Qualifier:
- according to guideline
- Guideline:
- other: J. Officiel de la Republique Francaise (1971). Methodes officielles d’analyse des cosmetiques et produits de beaute. Annexe II: Methode officielle pour la determination de i’irritation oculaire. Arrete du 5 Avril 1971. Journal Officiel 21 April. p. 3862.
- Version / remarks:
- 1971
- Qualifier:
- according to guideline
- Guideline:
- other: J. Officiel de la Republique Francaise (1973). Methodes officielles d’analyse des cosmetiques et produits de beaute. Annexe II: Methode officielle pour la determination de i’irritation oculaire. Arrete du 16 Avril 1973. Journal Officiel 05 June. p. 3953.
- Version / remarks:
- 1973
- Principles of method if other than guideline:
- The scoring system of Kay and Calandra (1962, J. Soc. cosmet. Chem. 13, pp. 281) was used.
- GLP compliance:
- no
Test material
- Reference substance name:
- Metformin hydrochloride
- EC Number:
- 214-230-6
- EC Name:
- Metformin hydrochloride
- Cas Number:
- 1115-70-4
- Molecular formula:
- C4H11N5.ClH
- IUPAC Name:
- N,N-dimethylimidodicarbonimidic diamide hydrochloride
- Test material form:
- solid: bulk
- Remarks:
- migrated information: powder
Constituent 1
- Specific details on test material used for the study:
- Beige Powder
pH 6-7 (saturated aqueous solution)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Roucher SA, Couhe, France
- Age at study initiation:
- Weight at study initiation: 2 - 5 kg
- Housing: group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: comperative study including 56 compounds with also non irritant compounds to be used as control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- rinsing after:
a) 4s
b) 30 s
c) no rinsing performed - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 18 males:
first group of 6 males without rinsing, second group of 6 males with rinsing after 4s, and third group of 6 males with rinsing after 30s. - Details on study design:
- The test substance was ground, to produce a fine dust for instillation. This involved a deviation from the Cosmetic protocol,
which specifies 20% (w/v) aqueous dilution of powders. The pH of the test substance was determined with 7.6
Rinsing solution Rinsing, when required, was generally carried out with Dacryoserum (from Chibret Laboratories, Paris), a solution of boric acid (1.8 g), sodium borate (1.2 g), sodium chloride (0.3 g) and phenylmercury
borate (0.002 g) in 100 ml rose distilled water QSP.
Dosing and observation. Test substance (100 mg) was instilled into the lower conjunctival cul-de-sac of one eye of each rabbit; the other eye constituted the control.
Interpretation
At each observation time, lesions of the conjunctiva. iris and cornea were scored separately using a numerical system based on that of Kay & Calandra (1962), the sum of these scores being the individual
ocular irritation index (IOI) for each animal. Calculation of the mean (and standard deviation) of the IOI values obtained at any one time gave the mean ocular index (MOI). The greatest MOI obtained over the range of observation times was identified as the acute ocular irritation index (AOI), which was used for the preliminary classification of a substance in one of six categories between ‘non-irritant’ and ‘extremely
irritant’. In the AFNOR interpretation, which takes into account not only the maximum intensity of the lesion but also its reversibility, the preliminary classification is modified if recovery is not virtually complete within 4 days. by evaluating the fall in MOI with time and, after 7 days, the frequency of the persisting lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Acute Ocular Irritation Index (AOI)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 16.67
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: MOI = 4.17 (day 4)
- Remarks:
- no rinsing
- Irritation parameter:
- other: Acute Ocular Irritation Index (AOI)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 16.83
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 4 days
- Remarks on result:
- other: MOI = 0 (day 4)
- Remarks:
- rinsing after 30 s
- Irritation parameter:
- other: Acute Ocular Irritation Index (AOI)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 9.33
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: MOI = 0.83 (day 4)
- Remarks:
- rinsing after 4 s
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In conclusion, based on these results, Metformin hydrochloride is considered as irritating to eyes and classified into category 2, H319 according to the CLP Regulation (EC) N° 1272/2008 and according to the Directive 67/548/EEC.
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