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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
20 Oct 1975 - 27 Oct 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given (no data on analytical purity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
limited reporting; no data on analytical purity
Principles of method if other than guideline:
Six rabbits were treated with 0.1 g substance/eye without washing of.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sorbitan stearate
EC Number:
215-664-9
EC Name:
Sorbitan stearate
Cas Number:
1338-41-6
Molecular formula:
Molecular formula cannot be given as substance is a mixture.
IUPAC Name:
1,4-anhydro-6-O-stearoyl-D-glucitol
Details on test material:
- Name of test material (as cited in study report): Only trade name given
- State of material: tan wax chunks
- Analytical purity: not reported
- Lot/batch No.: 7044C-RT

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eyes served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 d
Reading time points: 1, 24, 48, 72, 96 h and 7 d
Number of animals or in vitro replicates:
5 males and 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing performed

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: unwashed
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.06
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: unwashed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: unwashed
Irritant / corrosive response data:
Only slight and transient conjunctivae redness was seen. One eye showed slight redness at 24 h, but no effect was seen in any of the eyes thereafter.

Any other information on results incl. tables

Reading scores:

Rabbit # Time [h] conjunctivae iris cornea
redness swelling discharge Opacity area
1 1 1 0 0 0 0 0
24 1 0 0 0 0 0
48 0 0 0 0 0 0
72 0 0 0 0 0 0
96 0 0 0 0 0 0
7 days 0 0 0 0 0 0
average 0.3 0.0   0.0 0.0  
2 1 1 0 0 0 0 0
24 0 0 0 0 0 0
48 0 0 0 0 0 0
72 0 0 0 0 0 0
96 0 0 0 0 0 0
7 days 0 0 0 0 0 0
average 0.0 0.0   0.0 0.0  
3 1 1 0 0 0 0 0
24 0 0 0 0 0 0
48 0 0 0 0 0 0
72 0 0 0 0 0 0
96 0 0 0 0 0 0
7 days 0 0 0 0 0 0
average 0.0 0.0   0.0 0.0  
4 1 1 0 0 0 0 0
24 0 0 0 0 0 0
48 0 0 0 0 0 0
72 0 0 0 0 0 0
96 0 0 0 0 0 0
7 days 0 0 0 0 0 0
average 0.0 0.0   0.0 0.0  
5 1 1 0 0 0 0 0
24 0 0 0 0 0 0
48 0 0 0 0 0 0
72 0 0 0 0 0 0
96 0 0 0 0 0 0
7 days 0 0 0 0 0 0
average 0.0 0.0   0.0 0.0  
6 1 1 0 0 0 0 0
24 0 0 0 0 0 0
48 0 0 0 0 0 0
72 0 0 0 0 0 0
96 0 0 0 0 0 0
7 days 0 0 0 0 0 0
average 0.0 0.0   0.0 0.0  

Mean scores over 24, 48 and 72 h:

Time [h] conjunctivae iris cornea
redness swelling    
24 0.2 0.0 0.0 0.0
48 0.0 0.0 0.0 0.0
72 0.0 0.0 0.0 0.0
mean over 24, 48 and 72 0.1 0.0 0.0 0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classifed