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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Dec 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance Hexanoic acid, 2-ethyl-, 2,2-bis [ [(2-ethyl-1-oxohexyl)oxy] methyl] -1,3-propanediyl ester. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

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)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
EC Number:
230-743-8
EC Name:
2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)
Cas Number:
7299-99-2
Molecular formula:
C37H68O8
IUPAC Name:
3-[(2-ethylhexanoyl)oxy]-2,2-bis{[(2-ethylhexanoyl)oxy]methyl}propyl 2-ethylhexanoate
Details on test material:
- Name of test material (as cited in study report): Tetraoctanoate de Pentaerythritol
- Analytical purity: not reported
- Storage condition of test material: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CARON-St Germain-Laxis, 77950 Maincy, France
- Sex: male
- Weight at study initiation: about 2.5 - 3 kg
- Housing: in individual polysterene cages of standardized dimensions with perforated floor
- Diet: Pietrement C15, ad libitum
- Water: tap water provided in sterilized makrolon bottles equipped with stainless steel pipettes, ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 50 - 80
- Air changes (per hr): 3000 m³
- 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(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Reading time points: 4, 24, 48, 72 h and 7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM:
Draize scoring system according to EEC guideline 67/548

TOOL USED TO ASSESS SCORE: 2% aequous solution of sodium fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 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:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The observed lesions in all 3 animals were benign, exclusively conjunctival and of low intensity. They are fully reversible by day 2.

Any other information on results incl. tables

Table 1: Individual scores of the animals.

Reading time point

Animal No.

Cornea

Iris

Conjunctiva

Area of opacity

Opacity

Redness

Chemosis

Lacrimation

4 h

1100

0

0

0

2

0

0

1101

0

0

0

2

0

0

1102

0

0

0

2

0

0

24 h

1100

0

0

0

1

0

0

1101

0

0

0

1

0

0

1102

0

0

0

1

0

0

48 h

1100

0

0

0

0

0

0

1101

0

0

0

0

0

0

1102

0

0

0

0

0

0

72 h

1100

0

0

0

0

0

0

1101

0

0

0

0

0

0

1102

0

0

0

0

0

0

7 days

1100

0

0

0

0

0

0

1101

0

0

0

0

0

0

1102

0

0

0

0

0

0

mean 24-48-72 h

1100

0.0

0.0

0.0

0.3

0

0.0

1101

0.0

0.0

0.0

0.3

0

0.0

1102

0.0

0.0

0.0

0.3

0

0.0

mean

0.0

0.0

0.0

0.3

0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified