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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Studies conducted pre-GLP standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Regulations for the Enforcement of the Federal Hazardous Substances Act. F.R. Sept. 17, 1964
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Stearic acid
EC Number:
200-313-4
EC Name:
Stearic acid
Cas Number:
57-11-4
Molecular formula:
C18H36O2
IUPAC Name:
stearic acid
Details on test material:
- Analytical purity: no data
- Physical state: white solid - melted and allowed to cool before application
- Batch no.: 1922-67
- Carbon chain length distribution: C18.

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino

Test system

Vehicle:
not specified
Controls:
other: the untreated left eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
Reading time points: 24, 48 and 72 hours
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No Lesions were observed after application of 0.1 mL test substance in rabbits eyes.

Any other information on results incl. tables

Scores for Ocular Lesions

Rabbit No.

24 hrs.

48 hrs.

72 hrs.

13

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

    Redness

    Chemosis

    Discharge

0    

0    

0

0

0

0

0  

0  

0

0

0

0

0

0

0

0

0

0

14

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

    Redness

    Chemosis

    Discharge

0    

0    

0

0

0

0

0  

0  

0

0

0

0

0

0

0

0

0

0

15

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

    Redness

    Chemosis

    Discharge

0    

0    

0

0

0

0

0  

0  

0

0

0

0

0

0

0

0

0

0

16

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

    Redness

    Chemosis

    Discharge

0    

0    

0

0

0

0

0  

0  

0

0

0

0

0

0

0

0

0

0

17

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

    Redness

    Chemosis

    Discharge

0    

0    

0

0

0

0

0  

0  

0

0

0

0

0

0

0

0

0

0

18

Cornea opacity, degree

Cornea opacity, area

Iris

Conjunctiva

    Redness

    Chemosis

    Discharge

0    

0    

0

0

0

0

0  

0  

0

0

0

0

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:
DSD: not classified
CLP: not classified