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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.