Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50µl or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline-treated adjacent eye served as a control. In studies with solids, talcum powder was used as a control. The animals were observed several times on the treatment day and up to 7 or 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 hours as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage, which would probably be less severe if it had been washed out after 1 day. The report usually describes findings after 1 and 24 hours, and at the end of the 8-day observation period.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyryl chloride
EC Number:
201-194-1
EC Name:
Isobutyryl chloride
Cas Number:
79-30-1
Molecular formula:
C4H7ClO
IUPAC Name:
isobutyryl chloride
Details on test material:
- Name of test material (as cited in study report): Isobuttersäurechlorid

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
50 µl
Duration of treatment / exposure:
single application, no washing was performed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: findings 1 hour after application
Time point:
other: 1 h
Reversibility:
not reversible
Remarks on result:
other: corrosive effects on the eyeball, edges of eyelids and eye mucosa
Irritation parameter:
other: findings 24 hours after application
Time point:
other: 24 h
Reversibility:
not reversible
Remarks on result:
other: erythema, edema, cloudy eyes, iritis, foul secretion from the eyes, corrosion and bleeding of eye mucosa, partial corrosion of eye lid edges
Irritation parameter:
other: findings after 8 days
Time point:
other: 8 d
Reversibility:
not reversible
Remarks on result:
other: erythema, cloudy eyes, crusts on the eyelids, staphyloma
Irritation parameter:
other: cauterization
Time point:
other: 1 and 24 h, 8 d
Reversibility:
not reversible
Remarks on result:
other: cauterization was observed at all time points

Applicant's summary and conclusion

Interpretation of results:
highly corrosive
Remarks:
Migrated information