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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 17 until May 24, 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
24 Feb 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
31 July 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
419-310-6
EC Name:
-
Cas Number:
125248-71-7
Molecular formula:
C39H44O10
IUPAC Name:
2-methyl-4-(4-{[6-(prop-2-enoyloxy)hexyl]oxy}benzoyloxy)phenyl 4-{[6-(prop-2-enoyloxy)hexyl]oxy}benzoate
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 32 to 33 weeks
- Weight at study initiation: 3.91 (3.74 - 4.03) kg
- Housing: separately in cages type KK 017 (floor area: 75 x 54.4 = 4087 cm2), height: 38 cm) on metal grids
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 18
- Humidity (%): 42 - 57

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g

Duration of treatment / exposure:
Eyelids were closed for about 30 seconds.
Observation period (in vivo):
1 hour after treatment, and then after 24, 48, 72 hours and so on for a period of further 4 days.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none

SCORING SYSTEM: according to OECD Guideline

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The conjunctivae showed redness (score 1) one hour after treatment in all 3 animals. Chemosis was observed one hour after instillation in animal 1 only.
Other effects:
- Lesions and clinical observations: none
- Ophthalmoscopic findings: none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the available data obtained from a Guideline conform study according to OECD 405 performed under GLP conditions, the test item is not considered to be irritating to rabbits' eye.
Executive summary:

To test for primary eye irritation, the test material was instilled undamped into the conjunctival sac of rabbits.

The first examination of the eyes followed 1 hour after instillation. Then, examinations were performed daily for further 7 days.

The conjunctivae showed redness (score 1) one hour after treatment in all 3 animals. Chemosis was observed one hour after instillation in animal 1 only.

In all animals the individual mean scores (considering readings 24, 48, and 72 hours after instillation) of each animal were 0 for cornea opacity score, iris score and chemosis. In animal 1 the individual mean score (considering readings 24, 48, and 72 hours after instillation) was 0.33 for redness. Furthermore, no signs of systemic toxicity, no mortality and a normal body weight gain were observed. Signs of irritation were fully reversible. The untreated eyes were normal.

Under the conditions of the present study, the test item is not considered to be irritating to eye.