Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Observation period lasted 7 days.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Sulfuric acid, mono-C12-13-alkyl esters, sodium salts
EC Number:
295-101-1
EC Name:
Sulfuric acid, mono-C12-13-alkyl esters, sodium salts
Cas Number:
91783-23-2
IUPAC Name:
91783-23-2
Details on test material:
- Name of test material (as cited in study report): trade name
- Physical state: No data
- Analytical purity: 27% a.s.
- Lot/batch No.: No data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
According to Guideline.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
0.3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
0.3
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information R41 Criteria used for interpretation of results: EU