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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-02-05 to 1979-02-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA-gudieline
Version / remarks:
(Federal register 38; No. 187, 27.9.1973, p 27019)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
EC Number:
305-644-9
EC Name:
Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
Cas Number:
94891-43-7
Molecular formula:
C32 H16 N8 Ni . C8 H11 N O6 S2 . 2 Na
IUPAC Name:
Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Remarks:
Albino-Himalayan-rabbit (Hoe: HIMK (SPFWiga))
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: inhouse
- Weight at study initiation: 1.5 - 2.5kg
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (ERKA 8300 (Futtermittelwerk Robert Koch oHG))
- Water (e.g. ad libitum): ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL undiluted test item
- Concentration (if solution): undiluted test item
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 7, 24, 48, 72h after application
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 24h

SCORING SYSTEM: according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"; FDA, Austin, Texas, p51,1975

TOOL USED TO ASSESS SCORE: magnifying-glass, prior to observation time 48 and 72h: one drop of 1:10000 (=0.01%) Fluorecein-sodium solution

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 48h
Other effects:
Nictitating membrane and mucous membrane were colored greenish-blue

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance was considered to be not eye irritant. The substance is not classifiable according to CLP criteria.