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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2021
Report date:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
Constituent 2
Reference substance name:
Jojoba Esters
Cas Number:
61789-91-1
IUPAC Name:
Jojoba Esters
Constituent 3
Reference substance name:
Alcohols, C14-22 and C16-22-unsatd.
EC Number:
268-107-7
EC Name:
Alcohols, C14-22 and C16-22-unsatd.
Cas Number:
68002-95-9
IUPAC Name:
Alcohols, C14-22 and C16-22 unsaturated
Constituent 4
Reference substance name:
Fatty acids, C14-22 and C16-22-unsatd., potassium salts
EC Number:
286-079-4
EC Name:
Fatty acids, C14-22 and C16-22-unsatd., potassium salts
Cas Number:
85186-93-2
IUPAC Name:
Fatty acids, C14-22 and C16-22 unsaturated, potassium salts
Test material form:
semi-solid (amorphous): gel
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: SC21C31A
- Purity.: 100%

Test animals / tissue source

Species:
human

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
- Concentration (if solution): 100%


Duration of treatment / exposure:
50 mg of the undiluted test substance are applied on the top of each tissue for 6 hours ± 15 minutes
Duration of post- treatment incubation (in vitro):
18 hours
Number of animals or in vitro replicates:
Test is performed in duplicate: 2 wells per test substance, 2 for positive control and 2 for negative control for each experimental condition

Results and discussion

In vitro

Results
Irritation parameter:
mean percent tissue viability 
Run / experiment:
2
Value:
>= 104.9 - <= 109.2
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The Test material is not an eye irritant.