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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
November 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13

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: Code of Federal Regulations, Title 16, Section 1500.42
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Acid Brown 188:2 - Similar Substance 01
IUPAC Name:
Acid Brown 188:2 - Similar Substance 01
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:experimental breeder Extertal 1
- Weight at study initiation:1.9 kg
- Housing:individual cage
- Diet : "mummel Z" ad libitum
- Water : ad libitum
- Acclimation period:7-14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18 °C
- Humidity (%):40%
- Photoperiod : 12 hours cycle dark/light

Test system

Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied : single injection 100 µL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24, 48, 72 and 8 days
Number of animals or in vitro replicates:
6 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes, at the end of exposure period, with saline solution.

SCORING SYSTEM: cornea, iris, conjunctiva

TOOL USED TO ASSESS SCORE: fluoresceine, ophthalmoscope.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 days
Score:
ca. 4.6
Max. score:
110
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
other: not classified under Regulation 1272/2008
Conclusions:
Not irritating on rabbit eye
Executive summary:

The substance was tested for eye irritation according to Federal Regulations, Title 16 , Section 1500.41 . The value of the irritation was = 4.6 (not irritant), but all parameters return to normal value after 8 days.

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