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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline no. 437
Deviations:
no
Principles of method if other than guideline:
Bovine corneal opacity and permeability test (BCOP test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-aminotoluene-3-sulphonic acid
EC Number:
201-831-3
EC Name:
4-aminotoluene-3-sulphonic acid
Cas Number:
88-44-8
Molecular formula:
C7H9NO3S
IUPAC Name:
2-amino-5-methylbenzene-1-sulfonic acid
Constituent 2
Reference substance name:
4B-Acid
IUPAC Name:
4B-Acid
Details on test material:
Purity: 98,9%

Test animals / tissue source

Species:
other: Bovine

Test system

Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
Negative control: 750 µl physiological saline
Positive control: 750 µl 20% (w/v) imidazole solution
4B-Acid: 750 µl 20% (w/v) 4B-acid suspension
Duration of treatment / exposure:
240±10 min

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Run / experiment:
240 min.
Value:
ca. 24
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 240 min
Score:
24
Reversibility:
not specified
Irritant / corrosive response data:
Opacity score:
Eye Opacity before treatment Opacity after treatment Final opacity Negative control corrected final opacity Mean opacity
Negative control
1 0 0 0 0
2 0 1 1 1 0
3 0 0 0 0
Positive control
4 0 80 80 80
5 0 79 79 79 80
6 0 81 81 81
4B-Acid
13 0 19 19 19
14 0 29 29 29 24
15 0 24 24 24

Permeability score(corrected):
Eye Dilution factor OD490-1 OD490-2 OD490-3 Average OD Dilution corrected final OD Dilution corrected average OD
Negative control
1 1 0,014 0,001 0,004 0,006 0,006
2 1 0,000 0,000 0,003 0,001 0,001 0,000
3 1 -0,001 -0,008 -0,009 -0,006 -0,006
Positive control
4 6 0,369 0,366 0,372 0,369 2,214
5 6 0,349 0,362 0,354 0,355 2,130 2,490
6 6 0,527 0,518 0,519 0,521 3,126
4B-acid
13 1 -0,010 -0,008 -0,006 -0,008 -0,008
14 1 -0,004 0,002 -0,006 -0,003 -0,003 -0,006
15 1 -0,009 -0,005 -0,006 -0,007 -0,007

Any other information on results incl. tables

In vitro irritability score (IVIS) = mean opacity value + (15*mean OD490 value)

Mean opacity Mean permeability Mean IVIS
Negative control 0 0,000 0
Positive control 80 2,490 117
4B-acid 24 -0,006 24

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The mean in vitro irritancy score was 24 after 240 minutes of treatment with 4B-acid. Since this is below 55,1 4B-acid is considered to be Non-irritating