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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
03 Jun -10 Jun 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP-Guideline study, tested with the source substance Decanoic acid, mixed diesters with octanic acid and propylene glycol (CAS No. 68583-51-7). 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:
1988
Report date:
1988

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
Reference substance name:
Decanoic acid, mixed diesters with octanoic acid and propylene glycol
EC Number:
271-516-3
EC Name:
Decanoic acid, mixed diesters with octanoic acid and propylene glycol
Cas Number:
68583-51-7
IUPAC Name:
68583-51-7
Details on test material:
- Name of test material (as cited in study report): [trade name], Polypropylenglykol-di-Fettsäureester
- Physical state: yellowish liquid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleinrusse Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation: adult animals
- Weight at study initiation: mean 2457.5 g
- Housing: single holding in cage
- Diet: Altromin-Haltungsdiät 2023 (Altomin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Identification of animals: Ear tattoo and cage labelling
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 45-55
- 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):
72 h
Reading time points: 1, 6, 24, 48 and 72 h
Number of animals or in vitro replicates:
4 males
Details on study design:
PRELIMINARY CONTROL:
The eyes of the animals were visually controlled and with fluorescein, 24 h prior to application.

MAIN STUDY:
A control of the treated eye with fluorescein was conducted, 24 h after application and after macroscopic control of the eye.

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 4 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 4 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:
mean
Remarks:
out of all 4 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 4 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:
Cornea: no effects were observed during the study period in any animal.
Iris: no effects were observed during the study period in any animal.
Conjunctivae: after 1 h mild redness was observed in 2 of 4 animals. In one of theses animals the effect was fully reversible within 6 h after application. The second animal showed mild redness until 6 h after application being fully reversible after 24 h as well.
Chemosis: no effects were observed during the study period in any animal.
Exudation: no effects were observed during the study period in any animal.


Other effects:
No further local or systemic effects were reported.

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