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Toxicological information

Eye irritation

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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:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1982
Report Date:
1982
Reference Type:
other: legal text
Title:
Unnamed
Year:
1971

Materials and methods

Principles of method if other than guideline:
Official French methods for cosmetics, Annex II
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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"

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).