Registration Dossier
Registration Dossier
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EC number: 249-125-4 | CAS number: 28654-73-1
Eye irritation
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:
- 1 976
- 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
- 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
Constituent 1
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
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