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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 11th, 1988 - March 18th, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

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, C14-18 and C16-18-unsatd., Me esters
EC Number:
267-007-0
EC Name:
Fatty acids, C14-18 and C16-18-unsatd., Me esters
Cas Number:
67762-26-9
IUPAC Name:
67762-26-9
Details on test material:
- Name of test material (as cited in study report): Fettsäuremethylester (C14-18 und C16-18)
- Physical state: yellow, clear liquid
- Analytical purity: no data

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, D
- Weight at study initiation: 2540 g
- Housing: individually in rabbit batteries
- Diet (ad libitum): Altromin-Haltungsdiät 2023
- Water (ad libitum): tap water
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
not specified
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
4
Details on study design:
SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 4 tested animals and mean of readings at
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 4 tested animals and mean of readings at
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 4 tested animals and mean of readings at
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Slight effects occurred after 1 hour (Redness).
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 4 tested animals and mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritant / corrosive response data:
Reactions on cornea and iris were not observed. The conjunctival reactions were slight (redness) and dissappeared within 24 hours after application.

Applicant's summary and conclusion

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