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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]
EC Number:
285-089-6
EC Name:
Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]
Cas Number:
85029-63-6
Molecular formula:
not applicable, mixture
IUPAC Name:
Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Origin: HOECHST AG, Kastengrund, conventional breed
Body weights: 3.5 - 4.0 kg
Age: approx. 3 - 5 months

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml per eye
Duration of treatment / exposure:
24 h
Observation period (in vivo):
The eyes were examined at 1h, 24 h, 48 h and 72 h after application of the test substance.
Number of animals or in vitro replicates:
3 animals
Details on study design:
Approximately 24 h before study start the eyes intended for treatment with the test substance were assessed after application of one drop of a 0.01 % sodium fluoresceine solution into the eye under UV light for damages of the cornea. Only animals with eyes without damages of the cornea were used for the study.
Each of the 3 animals was treated on the left eye's conjunctivae with 0.1 ml of test substance. The untreated right eye was used as control. The treated eyes were rinsed thoroughly with physiological saline solution (at 37 °C) 24 h after the application of the test substance and at each timepoint when the treated eyes showed secretion or when the cornea was assessed with sodium fluoresceine solution.
The treated eyes were assessed 1 h, 24 h, 48 h and 72 h after application of the test substance. At the 24 h and 72 h assessments, the cornea was assessed for damages as well after instillation of 0.01 % sodium fluoresceine solution under UV light. Damages to the cornea, iris and conjunctiva was assessed and scored numerically..

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
After 1 hour of the test substance application, the conjunctivae of the animals were coloured diffuse karmesin red to strong red and slightly swollen. In addition, clear and colorless secretion occurred. After one day after application, clear hyperemia of the conjunctivae blood vessels were observed. However, on day 2 after application of the test substance, all irritation signs were reversible.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not eye-irritating.
Executive summary:

The eye irritation potential of the test substance was assessed in a study according to OECD guideline 405 in rabbits. As a result of the study, the substance showed to be not irritating to the eye.