Registration Dossier
Registration Dossier
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EC number: 203-529-7 | CAS number: 107-88-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was performed according to a national guideline (Official French methods for cosmetics, Annex II), which is similar to the guidelines EU B5 and OECD 405, but lacks details in data presentation (e.g. insufficient information on purity of the test substance).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
- Reference Type:
- other: legal text
- Title:
- Unnamed
- Year:
- 1 971
Materials and methods
- Principles of method if other than guideline:
- Official French methods for cosmetics, Annex II
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Butane-1,3-diol
- EC Number:
- 203-529-7
- EC Name:
- Butane-1,3-diol
- Cas Number:
- 107-88-0
- Molecular formula:
- C4H10O2
- IUPAC Name:
- butane-1,3-diol
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): butylene glycol,
purity not stated, but "specifications of test material ... corresponding to those regularly employed in industry"
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- male albino rabbits with healthy eyes (without defects)
animal weight: 2 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 18 h
- Observation period (in vivo):
- Evaluation of effects was performed after 1 h, 24 h, 2, 4 and 7 days.
- Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- The test substance was instilled under the lower lid of one eye and the lids were held closed for several seconds to prevent loss of the test substance.
The animals were kept immobilised for 18 h, and then transferred to their cages.
For the improved detection of opacity, the eyes were stained with 2% aqueous fluorescein solution. Examination was performed by an opthalmoscope and a retinographe.
The untreated eye served as control.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: acute ocular irritation index
- Basis:
- mean
- Time point:
- other: 18 h
- Score:
- 12.33
- Max. score:
- 110
- Reversibility:
- not specified
- Irritant / corrosive response data:
- The acute ocular irritation index (AOII) of the undiluted test substance was 12.33 (slight irritation)
Applicant's summary and conclusion
- Interpretation of results:
- other: slightly irritating
- Conclusions:
- Under these study conditions, the test substance was slightly irritating.
- Executive summary:
The undiluted test substance produced a slight irritation of the rabbit's eye (Guillot et al., 1982).
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