Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991 May-June
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Guideline study under GLP

Data source

Reference
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Fatty acids, C16-18, esters with pentaerythritol
EC Number:
285-547-5
EC Name:
Fatty acids, C16-18, esters with pentaerythritol
Cas Number:
85116-93-4
IUPAC Name:
85116-93-4
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
Henkel, 51531022
- Expiration date of the lot/batch: 1992 July 25
- Purity test date: 1991 January 25

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Stable up to 18 months
- Solubility and stability of the test substance in the solvent/vehicle:
Stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
N/A
- Final dilution of a dissolved solid, stock liquid or gel:
Test substance was suspending in Tween 80 (1:1 ratio), heated to 70 °C, and diluted with distilled water to desired concentration

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrussen
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach/D.
- Age at study initiation: 4 months
- Weight at study initiation: 2090 g
- Housing: single cages
- Diet (e.g. ad libitum): ad libitum Ssniff rabbit diet K4, Ssniff GmbH, Soest/D.
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature, 20-25 °C
- Humidity (%): 45-70%
- Photoperiod (hrs dark / hrs light): 12 hrs

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 hours

SCORING SYSTEM: Cornea opacity (0-4), Iris (0-2), Conjunctivae redness (0-3), Conjunctivae chemosis (0-4), Exsudation (0-3)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
other: exsudation
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
1
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was evaluated for eye irritation under OECD guideline 405. The test substance did not cause eye irritation in rabbits.