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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

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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
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. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
[(2-chlorophenyl)methylene]malononitrile
EC Number:
220-278-9
EC Name:
[(2-chlorophenyl)methylene]malononitrile
Cas Number:
2698-41-1
Molecular formula:
C10H5ClN2
IUPAC Name:
[(2-chlorophenyl)methylene]malononitrile
Constituent 2
Chemical structure
Reference substance name:
4-methylpentan-2-one
EC Number:
203-550-1
EC Name:
4-methylpentan-2-one
Cas Number:
108-10-1
Molecular formula:
C6H12O
IUPAC Name:
4-methylpentan-2-one
Constituent 3
Chemical structure
Reference substance name:
hexyl acetate
Cas Number:
88230-35-7
Molecular formula:
C8H16O2
IUPAC Name:
hexyl acetate
Constituent 4
Chemical structure
Reference substance name:
Dimethyl glutarate
EC Number:
214-277-2
EC Name:
Dimethyl glutarate
Cas Number:
1119-40-0
Molecular formula:
C7H12O4
IUPAC Name:
dimethyl glutarate
impurity 1
Reference substance name:
unknown impurities
Cas Number:
Not applicable
Molecular formula:
Not applicable
IUPAC Name:
unknown impurities
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).