Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Jun -10 Jun 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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
Chemical structure
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
Molecular formula:
C21H44O6
IUPAC Name:
Waglinol 2/7680

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 wasching
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:
animal: #1, #2, #3 and #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3 and #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3 and #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3 and #4
Time point:
24/48/72 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:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.