Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (incomplete documentation, 50 mg application amount, 2 animals, 72 h scoring not performed)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(reduced application amount, 72 h scoring not performed, 2 animals)
Principles of method if other than guideline:
BASF-test:
50 mg of the test substance were applied to the conjunctival sac of one eye of two white Vienna rabbits. Talcum powder was used as a control. Animals were observed for 8 days and skin changes were observed on working days. The substance was not washed out. Findings were graded as described in OECD test guideline 405.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
EC Number:
249-125-4
EC Name:
[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper
Cas Number:
28654-73-1
Molecular formula:
C47 H49 Cu N11
IUPAC Name:
Copper,[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyanine-C,C,C-trimethanaminato(2-)-κN29,κN30,κN31,κN32]-
Details on test material:
Please refer to confidential details on test material

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.25 kg (male) and 3.16 kg (female)

ENVIRONMENTAL CONDITIONS: not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye of each animal was treated with talcum (amorph)
Amount / concentration applied:
50 mg of test material (100%)
Duration of treatment / exposure:
Single exposure without washing of the eyes.
Observation period (in vivo):
8 days (Eyes were observed (after application): 10 min; 1, 3, 24, 48 hours and 4, 7 and 8 days)
Number of animals or in vitro replicates:
2 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: evaluation was carried out according to the Draize scoring system.

TOOL USED TO ASSESS SCORE: fluorescein at the end of the observation period

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24 - 48 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 48 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Other effects:
Substance residues were seen until 3 h (animal #1) and until 24 h (animal #2) after application.
Weight of animal #1 and animal #2 at the end of the observation period was 3.07 kg and 3.23 kg, respectively.

Any other information on results incl. tables

The talcum-treated control eyes of the animals showed slight redness of the conjunctiva (Draize scoring system 1 of 3), which was fully reversible within 48 h in both animals. In the control eye of animal #2, chemosis score 1 (of 4) could be observed at 3 h after application, which was fully reversible within 24 h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information