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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
20 Apr - 27 Apr 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
adopted in 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol tristearate
EC Number:
209-097-6
EC Name:
Glycerol tristearate
Cas Number:
555-43-1
Molecular formula:
C57H110O6
IUPAC Name:
propane-1,2,3-triyl trioctadecanoate

Test animals / tissue source

Species:
rabbit
Strain:
other: Small White Russian, Mol. Russian, Chbb:MH
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Møllegaard Breeding & Research Center Ltd., Lille Skensved, Denmark
- Age at study initiation: adult animals
- Weight at study initiation: 2.2, 2.4 and 2.4 kg (animals #1, 2 and 3, respectively)
- Housing: conventional, single housing in stainless steel cages
- Diet: Ssniff K 4 complete feed for rabbits (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
24 h
Observation period (in vivo):
6 days
Reading time points: 1, 24, 48 and 72 h and 6 days
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eyes were were rinsed with warm physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
1 h post-instillation: some definitely hyperaemic (injected) blood vessels in 1 animal, diffuse, crimson red coloured mucous membranes (individual vessels were not easily discernible) in 2 animals. Swelling above normal of lids (and nictating membranes) and discharge in form of white mucous were observed in all 3 animals.
24-72 h post-instillation: the conjunctivae of all 3 animals still showed some definitely hyperaemic blood vessels.
6 days post-instillation: no more irritations on eye and mucous membrane were observed in any animal.
During the whole observation period, cornea and iris of all animals were free of any irritations.
Other effects:
No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Summary of results.

 

Rabbit #

Time [h]

conjunctivae

iris

cornea

redness

swelling

1

1

2

1

0

0

24

1

0

0

0

48

1

0

0

0

72

1

0

0

0

average

1.0

0.0

0.0

0.0

2

1

1

1

0

0

24

1

0

0

0

48

1

0

0

0

72

1

0

0

0

average

1.0

0.0

0.0

0.0

3

1

2

1

0

0

24

1

0

0

0

48

1

0

0

0

72

1

0

0

0

average

1.0

0.0

0.0

0.0

 

 

 

 

 

 

 

Time [h]

conjunctivae

iris

cornea

 

redness

swelling

average score

1

1.66

1.00

0.00

0.00

24

1.00

0.00

0.00

0.00

48

1.00

0.00

0.00

0.00

72

1.00

0.00

0.00

0.00

24+48+72

1.00*

0.00

0.00

0.00

 

* On Day 6 post-instillation, the conjuctival redness score was 0 in all animals.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
CLP: not classified