Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Age: 12-14 weeks
Body weight: 2 -3 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 5 days
Accomodation: Caged singly in metal cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG
Temperature of 17-23 °C and with a humidity of 30-70%
Animals were exposed to artificial light for 12 hours daily
Diet: Nafag n. 814 (Gossau, CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye serves as control
Amount / concentration applied:
0.1 g of the test substance
Duration of treatment / exposure:
eye lids close for 1 seconds
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
24-72 hours all animals
Time point:
other: 24-72 hours
Score:
1.33
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 hours
Score:
1
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 hours
Score:
2
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-72 hours
Score:
1.33
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
The tested substance ahowed a primary irritation score of:
1.33 for cornea
1 for iris
2 for conjunctivae redness
1.33 for conjunctivae chemosis
when applied to the rabbit eye mucosa.
The effect was not reversible in 21 days except for chemosis which is fully reversible within 14 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
OECD GHS
Conclusions:
The tested substance needs to be considered irritant for rabbits eyes under Regulation CE 1272/2008.
Executive summary:

The ocular reactions were determined followign OECD 405.

The tested substance is considered to be irritant for the rabbits eyes based on the results needs to be classified as H319, Causes serious eye irritation under Regulation 1272/2008.