4'-anilinotoluene-4-sulphonanilide

Eye irritation

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4'-anilinotoluene-4-sulphonanilide

EC Number:

202-902-1

EC Name:

4'-anilinotoluene-4-sulphonanilide

Cas Number:

100-93-6

Molecular formula:

C19H18N2O2S

IUPAC Name:

4'-anilinotoluene-4-sulphonanilide

Test animals / tissue source

Species:

cattle

Test system

Vehicle:

Hank's balanced salt solution

Controls:

yes, concurrent positive control

yes, concurrent negative control

Duration of treatment / exposure:

Exposure time on the corneas was 4 hours at 32 ± 1 °C. After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, both chambers were filled with cMEM without phenol red, and the final opacity value of each cornea was recorded.

Number of animals or in vitro replicates:

3

Results and discussion

In vitro

Results

Irritation parameter:

cornea opacity score

Value:

0.002

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Table 9.1‑d      Optical density at 492 nm of Blank

Parameter	cMEM without phenol red
1. Measurement	0.041
2. Measurement	0.035
3. Measurement	0.042
Mean	0.039

 

Table9.1‑e      Optical density at 492 nm of Negative Control, Test Item and Positive Control

Parameter	Negative Control			Test Item			Positive Control
	1. Rep.	2. Rep.	3. Rep.	1. Rep.	2. Rep.	3. Rep.	1. Rep.	2. Rep.	3. Rep.
1. Measurement	0.068	0.050	0.060	0.055	0.051	0.056	1.435	2.137	1.411
2. Measurement	0.064	0.047	0.054	0.056	0.051	0.055	1.463	2.140	1.413
3. Measurement	0.069	0.048	0.050	0.055	0.056	0.058	1.465	2.143	1.396
1. Measurement – blank	0.0287	0.0107	0.0207	0.0157	0.0117	0.0167	1.3957	2.0977	1.3717
2. Measurement – blank	0.0247	0.0077	0.0147	0.0167	0.0117	0.0157	1.4237	2.1007	1.3737
3. Measurement – blank	0.0297	0.0087	0.0107	0.0157	0.0167	0.0187	1.4257	2.1037	1.3567
Mean of each replicate	0.0277	0.0090	0.0153	0.0160	0.0133	0.0170	1.4150	2.1007	1.3673
Mean of the 3 replicates	0.0173			--			--
Corrected	--	--	--	-0.0013	-0.0040	-0.0003	1.3977	2.0833	1.3500
Corrected mean of the 3 replicates	--			-0.0019			1.6103

Rep. = Replicate

 

 

IVIS Values

The calculated IVIS for each replicate and the corresponding means are presented in the following table:

Table9.2‑a      IVIS

Test Group	IVIS	Mean IVIS	Relative Standard Deviation IVIS
Negative Control HBSS	0.37	1.81	69.47%
	2.69
	2.37
Test Item N-(4-anilinophenyl)-4-methylbenzenesulfonamide	-2.27	-0.76	-178.15%
	-0.32
	0.32
Positive Control 20% imidazole solution	94.27	94.64	0.35%
	94.74
	94.90

 

Note: the high relative standard deviations of the IVIS of test item and negative control are due to mathematical reasons, as the respective means are very small.

Under the conditions of this study, the test item N-(4-anilinophenyl)-4-methylbenzenesulfonamide showed no effects on the cornea of the bovine eye. The calculated IVIS is -0.76.

According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.

Applicant's summary and conclusion

Conclusions:

no classification for eye irritation or serious eye damage.