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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according to OECD-and EEC-Guidelines under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

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 (incl. QA statement)

Test material

Constituent 1
Details on test material:
Identification: TKA 40270
Product name: CGPS 345

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Air-conditioned with target ranges for room temperature 17-23 °C, relative humidity 30-70 % and approximately
10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have
occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and,
therefore, these data are not reported but are retained at RCC: The animals were provided with an automatically controlled light cycle of 12 hours
light and 12 hours dark.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL of test substance
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after instillation.
Number of animals or in vitro replicates:
3
Details on study design:
The primaty eye irritation potential ot TKA 40270 (GG PS 345) was investigated according to OEGD test guideline no. 405. The test item was applied
by instillation of 0.1 mL into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed
approximately 1, 24, 48 and 72 hours after test item instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(Chemosis)
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(Chemosis)
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(Chemosis)
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
(opacity)
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
(iris)
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
(iris)
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
(iris)
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
0
Other effects:
Slightly to moderately reddening of the conjunctivae was observed in all three animals trom the 1- to the 24hour reading. Slight to moderate swelling was noted in all animals at the 1-hour reading and persisted in one animal up to the 24-hour reading. Moderately reddening ot the sclerae was seen in all animals at the 1-hour reading. One animal showed slightly reddening ot the sclerae at the 24-hour reading. Slight ocular discharge was
observed in all animals at the 1-hour reading.
No abnormal tindirigs were observed in the treated eye of any animal 48 hours after treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered to be not irritating to the rabbit eye.