Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
2009
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
impurity
Specific details on test material used for the study:
Not specified

Test animals / tissue source

Species:
cattle
Strain:
not specified

Test system

Vehicle:
other: Dimethyl glutarate, Hexyl acetate or MIBK
Controls:
yes, concurrent positive control
yes, concurrent negative control

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
5% in dimethyl glutarate
Value:
ca. 6.7
Vehicle controls validity:
not examined
Remarks:
"corrected values"
Negative controls validity:
valid
Remarks:
0,9% sodium chloride score 2.1 mild irritant
Positive controls validity:
valid
Remarks:
absolute ethanol score 53 moderate irritant
Remarks on result:
positive indication of irritation
Remarks:
mean score on 3 corneas per vehicule
Irritation parameter:
in vitro irritation score
Run / experiment:
5% in hexyl acetate
Value:
ca. 2.6
Vehicle controls validity:
not specified
Remarks:
idem
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Remarks:
idem
Irritation parameter:
in vitro irritation score
Run / experiment:
5% in methyl isobutyl ketone
Value:
ca. 11.5
Vehicle controls validity:
not specified
Negative controls validity:
valid
Remarks:
idem
Positive controls validity:
valid
Remarks:
idem
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
Quality criteria required for acceptance of results in the test were satisfied

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
5% solutions of CS in dimethyl glutarate, hexyl acetate and MIBK were mild-irritants for the eyes (in vitro irritation score of 2.6 to 11.5, whereas positive control ethanol is 53).
Executive summary:

According to a BCOP assay following OECD 437 methodology, the results showed that 5% solutions of CS in dimethyl glutarate, hexyl acetate and MIBK were mild-irritants for the eyes (in vitro irritation score of 2.6 to 11.5, whereas positive control ethanol is 53). This result is published in (Croft, 2003).