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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
Note that in-vivo eye irritation should not have been attempted in view of results of in-vivo skin irritation. These historical data are included for information only
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Study provided on similar substance to help build up a weight of evidence demonstrating potential for read-across between the xanthates
Note that in-vivo eye irritation should not have been attempted in view of results of in-vivo skin irritation. These historical data are included for information only

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium O-isobutyl dithiocarbonate
EC Number:
246-805-2
EC Name:
Sodium O-isobutyl dithiocarbonate
Cas Number:
25306-75-6
Molecular formula:
C5H10OS2.Na
IUPAC Name:
sodium [(2-methylpropoxy)methanethioyl]sulfanide
Constituent 2
Reference substance name:
Sodium isobutyl xanthate
IUPAC Name:
Sodium isobutyl xanthate
Test material form:
other: water solution

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
water
Amount / concentration applied:
0.1 ml/eye as water solution pH=10.1, containing 456,1g/dm3 of the substance
Duration of treatment / exposure:
introduced into the conjunctival sacs of the right eye
Observation period (in vivo):
Observation were made after 1h, 24, 48 hours and then after 7 days
Number of animals or in vitro replicates:
1 male
Details on study design:
introduced into the conjunctival sacs of the right eye

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
probability of severe irritation
Irritation parameter:
other: IIPO
Time point:
other: 7
Score:
110
Reversibility:
not fully reversible within:
Remarks on result:
probability of severe irritation
Irritation parameter:
other: IIPO
Time point:
other: 1-48 h
Score:
77.7
Reversibility:
not fully reversible within:
Remarks on result:
probability of severe irritation
Irritant / corrosive response data:
After 1h, ¾ of the cornea surface was clouded,in the iris was noted congestion. The conjunctiva was reddened, red beet color, oedema, and discharge on palpebra. After 24h and 48h the changes in eye became more intense, pupil was visible in lower part of the eye, details of iris was not visible, the pupil reacted slowly on light. After 7 days changes in the eye became more intense, ¾ of cornea was clouded, in lower part of the cornea details of iris was not visible. In the cojunctiva of the lower palpebra necrosis was noted.
NOTE : This study should have been terminated immediately

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Sodium isobutyl xanthate should be consider as seriously injured substance of the rabbit eyes.
Executive summary:

Study provided on similar substance to help build up a weight of evidence demonstrating potential for read-across between the xanthates


Note that in-vivo eye irritation should not have been attempted in view of results of in-vivo skin irritation.  These historical data are included for information only