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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
151-21-3 (purity 25%)
IUPAC Name:
151-21-3 (purity 25%)
Details on test material:
- Name of test material (as cited in study report): Sulfuric acid, mono dodecyl ester sodium salt
- Physical state: aqueous solution
- Analytical purity: 25% a.i.
- Lot/batch No.: No data
- Storage condition of test material: No data

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrusse
Details on test animals or tissues and environmental conditions:
According to Guideline.

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
n.a.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
2.6
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24+48+72 h
Score:
1.1
Max. score:
4
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

Cornea

           time (hrs)                           time (days)
           1      6       24      48     72     7     10     14     17      21
mean A     0.75   0.75    1       1      1      1     0.75   0.75   0.75    0.75
mean B     1.5    1.25    4       3.25   3.25   2.75  2.25   2.25   2.25    1.75

A = cloudiness grade
B = cloudiness surface


Cornea (0.5 % aqueous fluorescein): mean 100 or 40 after 24 hrs or 21  days p.a.


Conjunctivae

           time (hrs)                           time (days)
           1      6       24      48     72     7     10     14     17      21
mean A     1      2       2.25    2.75   2.75   2.25  1.5    1.25   1.25    1.25
mean B     1.25   1       1.25    1      1      0.5   0.25   0      0       0
mean C     3      3       3       3      3      1     2.25   1.75   1.75    0.75

A = erythema
B = chemosis
C = exsudation

Reversibility: no

Applicant's summary and conclusion

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