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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
yes
Remarks:
lack of details on test substance
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, isotridecyl esters
EC Number:
306-084-8
EC Name:
Fatty acids, C16-18, isotridecyl esters
Cas Number:
95912-88-2
IUPAC Name:
95912-88-2
Details on test material:
- Name of test material (as cited in study report): Isotridecylstearat
- Physical state: colourless liquid
- Date of arrival: May 18th, 1987
- Analytical purity: not reported
- Stability: not reported

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrusse Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: not reported
- Weight at study initiation: mean: 2245 g
- Housing: single in rabbit cages, Henkel, Germany.
- Diet (e.g. ad libitum): Altromin standard diet 2023, Lage, Germany.
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): unchanged test substance
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

SCORING SYSTEM: according to 79/831/EWG, Annex V, Part B.

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 4 tested animals and mean value of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 4 tested animals and mean value of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 4 tested animals and mean value of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 4 tested animals and mean value of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information to rabbit eye Criteria used for interpretation of results: EU