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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
from 1998-12-07 to 1998-12-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: this study has been conduced following an accepted OECD guideline and in compliance with the GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
COS 98091
IUPAC Name:
COS 98091
Details on test material:
White powder
this substance was coded in the laboratory un der the reference 98-4493
Storage: at ambient temperature and out of the light in a romm especially fitted out to that effect.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Species: New Zealand albino rabbits
Origin: JEGARD Supplier (22120 Yffiniac, France)
Weight: superior to 1.8 kg, the day before application of the substance
Number and sex: 3 males
Acclimatization: for at least 5 days before the beginning of the test
Identification: each animal was identified by auricular ring and corresponding number was written on a label put on its cage
Housing: animals were individually housed, in stainless steel cages on floor grid
the cages were placed in limited-access premises, under air-conditioned temperature (20 +/- 3°C) and controlled relative humidity (HR= 50 +/- 20%).
Renewal of the air: 10 cycles per hour
The artificial lighting ensured a sequence of 12 hours light, 12 hours dark
Feeding: the complete diet was supplied under pelleted form ERGILAP Anco, delivered by COFNA (37018 Tours, France)
Drinking: tap water

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye is the control
Amount / concentration applied:
0.1 g of the test substance in the cunjunctival sac of one eye of each animal.
Duration of treatment / exposure:
After one hour of retention, animals were put back in their cages.
Observation period (in vivo):
cunjunctivae, iris and cornea were observed and the responses scored at 1h, 24h, 48h, 72h and 4 days after instillation by direct examination in white light.
Number of animals or in vitro replicates:
3 animals
Details on study design:
A single animal was test was employed. then two additional animals were tested.
0.1 g of the test substance in the cunjunctival sac of one eye of each animal.
After one hour of retention, animals were put back in their cages.
Cunjunctivae, iris and cornea were observed and the responses scored at 1h, 24h, 48h, 72h and 4 days after instillation by direct examination in white light.
In adition to the observations of cunjunctivae, iris and cornea, any other lesions were recorded and fully described.
After the recording observations at 24 hours, the eyes of all rabbits were further axamined after the instillation of fluorescein and rinsing 30 seconds later with 5 mL of 0.9% NaCl. Fluorescein was used for the following readings till no anomally was observed on the cornea.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24-72h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24-72h
Score:
ca. 0.7
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24-72h
Score:
ca. 1
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
animal #1
Time point:
other: 24-72h
Score:
ca. 1.3
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
animal #2
Time point:
other: 24-72h
Score:
ca. 1.3
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
animal #3
Time point:
other: 24-72h
Score:
ca. 1.7
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24-72h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24-72h
Score:
ca. 0.3
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24-72h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24-72h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24-72h
Score:
ca. 0.3
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24-72h
Score:
ca. 0.3
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
taking into account the criteria defined by the EEC 67/548 Directive and its successive amendments, the substance COS 98091 was not classified among the subsatnce irritant to eyes.
Executive summary:

The aim of the study was to assess qualitatively and quantitatively irrtancy or corrosion and the delay of appearence of the efects after single application of 0.1 g of test substance as such on eye in 3 rabbits.

The eye irritation reactions (redness and chemosis of cunjunctivae, iris and cornea lesions) were scored at 1 h, 24h, 48h, and 72h then 4 days after instillation.

The test substance was classified in accordance with the EEC 67/548 Directive and its successive amendements.