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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-01-07 to 1980-01-21
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:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)
EC Number:
310-133-9
EC Name:
Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)
Cas Number:
69997-91-7
Molecular formula:
C36H32CrN8O8S2.1/2C6H16N2.H
IUPAC Name:
Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)
Details on test material:
- Physical state: solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: in house breed
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: ad libitum, standard diet (NAFAG, No. 814, Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
single instillation, washing out was conducted for 3/6 animals after 30 sec.
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: 10 mL physiological saline
- Time after start of exposure: 30 sec

SCORING SYSTEM: According to Draize et al. (1959)

TOOL USED TO ASSESS SCORE: hand-slit lamp

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
Remarks on result:
other: unrinsed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: unrinsed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: unrinsed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: unrinsed
Irritant / corrosive response data:
No irritations were seen in any of the tested animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this experiment the test material was found to cause no irritation when applied to the rabbit eye mucosa.