Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand Rabbits, KFM (SPF quality)

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
72h
Observation period (in vivo):
1, 24, 48 and 72h after treatment
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: primary irritation score
Basis:
other: all animals
Time point:
other: 1 h
Score:
0.3
Irritation parameter:
overall irritation score
Basis:
other: all animals
Time point:
other: 24h
Score:
0
Irritation parameter:
overall irritation score
Basis:
other: all animals
Time point:
other: 48h
Score:
0
Irritation parameter:
overall irritation score
Basis:
other: all animals
Time point:
other: 72h
Score:
0
Other effects:
At one hour a score of one was seen in one animal. No inflammation was observed between 24 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Under the conditions of this experiment the substance was found to cause a primary irritation score of 0.3 after 1 hour. The scores were 0 in all animals at 24, 48 and 72 hours. The substance is not classified as irritating to the eye.