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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: Acceptable, well-documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(observation period: 20 days instead of 21 days)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oxooel 740 roh
- Substance type: product mixture
- Physical state: yellowish brown liquid
- Composition of test material, percentage of components: 2,2,4-trimethyIpentanediol-1,3-mono-i-butyrat / 2-ethylhexandiol-1,3 / 2,2-dimethylhexandiol-1,3-mono-i-butyrate: 33%, 2,2-dimethylhexanediol-1,3-di-i-butyrate / 2-ethyIhexanediol-1,3-mono-n-butyrate: 22%, 1-ethylpentenyl (2)-4-propyl-5,5 dimethyl-dioxane-1,3 / C8-diol-mono-i-butyrate: 14%, i-di-n-butylacetale / 2-ethylhexanol: 13%, 2,2-dimethylhexanediol-1,3: 8%, n-butanol: 3%, 2-ethylhexyl-n-butyrate: 1.5%, 2,4-di-propyl-5,5-dimethyl-dioxane-1,3: 1.5%, trimer-n-butyraldehyd: 1.0%, n-butyl-n-butyrate: 0.6%, 2,2,4-trimethylpentanediol-1,3: 0.3%, 2-ethyl-4-methylpentanediol-1,3-n-i-butyrate: 0.3%, 4-methyl-2-ethylpentanol: 0.2%, n-di-n-butylacetal: 0.2%, 2-ethylhexyl-i-butyrate: 0.2%, 4-methyl-2-ethylpentenal / 2-ethylhexanal: 0.1%, i-di-i-butylacetal: 0.1%, 2-i-propyl-4-propyl-5,5-dimethyl-dioxane-1,3: 0.02%, trimer-i-butyraldehyd: 0.01%, phosphor: 0.0013%, unknown substances: 3%, water: 0.1%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 3.21 kg, mean(females): 3.17 kg
- Housing: single
- Diet: about 130 g Kliba 341 (4 mm)/animal/day
- Water: about 250 mL tap water/animal/day
- Acclimation period: at least 8 days


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


Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL


Duration of treatment / exposure:
see observation period: no washing out conducted
Observation period (in vivo):
20 days
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
SCORING SYSTEM: according to OECD 405


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 20 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24/48/72 h
Score:
2.1
Max. score:
3
Reversibility:
not fully reversible within: 20 days
Remarks on result:
other: in 2 out of 3 animals
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 20 days
Remarks on result:
other: in 1 out of 3 animals

Any other information on results incl. tables

Animal  Reading  Cornea Iris Conjunctiva Comment
Opacity Redness Chemosis
1 1 hr 0 0 2 3  
2 1 hr 0 0 2 3  
3 1 hr 0 0 2 3  
1 24 hrs 1 1 1 1 RE/PC
2 24 hrs 1 0 2 1 RE/PC
3 24 hrs 1 0 2 2 RE/PC/S
1 48 hrs 1 1 2 1 RE/PC/S
2 48 hrs 1 0 2 1 RE/PC/S
3 48 hrs 1 0 2 2 RE/PC/S
1 72 hrs 1 1 3 1 RE/PC/S
2 72 hrs 1 0 3 1 RE/PC
3 72 hrs 1 0 2 2 RE/PC/S
1 8 days 2 2 3 1 RE/PC/S/LH/MV/S3
2 8 days 1 1 0 0 RE/PC/LH/S3
3 8 days 2 1 1 1 RE/PC/S/LH/S3
1 13 days 2 2 3 1 RE/PC/S/LH/MV/S3
2 13 days 1 1 1 0 RE/PC/LH/S3
3 13 days 3 2 2 1 RE/PC/S/LH/S3
1 20 days 2 0 0 0 RE/PC/LH/MV/S3
2 20 days 1 0 1 0 RE/PC/MV/S3
3 20 days 2 0 1 1 RE/S/MV/S3
1 24/48/72 hrs 1 1 2 1  
2 24/48/72 hrs 1 0 2.3 1  
3 24/48/72 hrs 1 0 2 2  
mean 24/48/72 hrs 1.0 0.3 2.1 1.3  
S3: loss of corneal tissue
LH: loss of hair at margins of eyelids
MV: marginal vascularization of the cornea
PC: pupil contracted
RE: small retraction in the eyelids
S: suppuration

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Due to the irreversible eye damages, the test substance has to be classified as irritating to the eyes (EU: Xi, R41; GHS: Cat. 1).
Executive summary:

The study is conducted according to OECD guideline 405 and is reliable. Due to irreversible eye damages, the test substance has to be classified as irritating to the eyes (EU: Xi, R41; GHS: Cat. 1).