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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study (405)

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:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
EC Number:
610-877-7
Cas Number:
52624-57-4
Molecular formula:
C6 H14 O3 . 3 (C3 H6 O . C2 H4 O)x
IUPAC Name:
Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)
Details on test material:
- Name of test material (as cited in study report): Lupranol VP 9053
- Analytical purity: technical grade
- Lot/batch No.: Batch 9

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach/Main, Germany
- Weight at study initiation: mean weight of two male animals: 3.33 kg; weight of female animal: 3.46 kg
- Housing: Cage made of stainless steel with wire mesh walk floors; floor area: 40 cm x 51 cm; one animal / cage; no bedding in the cages; sawdust in the waste trays
- Diet (e.g. ad libitum): Kliba 341; Kaiseraugust; Switzerland; about 130 g per animal per day
- Water (e.g. ad libitum): Tap water; about 250 ml per animal per day
- Acclimation period: at least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
the substance was not washed out
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3 animals; 2 males, 1 female
Details on study design:
SCORING SYSTEM: OECD Guideline 405

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
1.88
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 / 48 / 72 h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: individual scores: 3 / 2 / 2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 / 48 / 72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: individual scores: 2 / 2 / 0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 / 48 / 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: individual scores: 3 / 2 / 1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
0.78
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 / 48 / 72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: individual scores: 2 / 1 / 1
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 / 48 / 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 / 0 / 0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 / 48 / 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: individual scores: 2 / 1 / 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 / 48 / 72 h
Score:
0.11
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 / 48 / 72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: individual scores: 0 / 0 / 1
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 / 48 / 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 / 0 / 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 / 48 / 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 / 0 / 0
Other effects:
Corneal opacity of animal 1: there was no corneal opacity detected on reading time points 1, 24, 48 and 72 hours. But at reading time point 8, 15, and 21 days, the score was 1.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information