N-(carbamoylmethyl)taurine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 September 2018 - 13 September 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

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)

Version / remarks:

Adopted
09. Oct. 2017

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline for the Testing of Chemicals, Series on Testing and Assessment No. 160

Version / remarks:

“GUIDANCE DOCUMENT ON “THE BOVINE CORNEAL OPACITY AND PERMEABILITY (BCOP) AND ISOLATED CHICKEN EYE (ICE) TEST METHODS: COLLECTION OF TISSUES FOR HISTOLOGICAL EVALUATION AND COLLECTION OF DATA ON NON-SEVERE IRRITANTS”, 25. Oct. 2011

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Version / remarks:

For Identifying (i) Chemicals Inducing Serious Eye Damage and (ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage, adopted 14. Feb. 2017

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-(carbamoylmethyl)taurine

EC Number:

230-908-4

EC Name:

N-(carbamoylmethyl)taurine

Cas Number:

7365-82-4

Molecular formula:

C4H10N2O4S

IUPAC Name:

N-(carbamoylmethyl)taurine

Test material form:

solid

Specific details on test material used for the study:

Batch no. GL865320171205
Appearance: White crystalline powder
Composition: 2-((2-Amino-2-oxoethyl)amino)ethanesulfonic acid
Purity: ≥ 99% Assay (Titration)
Homogeneity: homogeneous
Expiry date: 05. Dec. 2019
Storage: Room temperature (20 ± 5 °C)

Test animals / tissue source

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Fresh bovine eyes were obtained, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container within 1 hour.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Replicate 1: 551.4 mg
Replicate 2: 550.3 mg
Replicate 3: 550.3 mg

Duration of treatment / exposure:

4 hours at 32 ± 1 °C

Duration of post- treatment incubation (in vitro):

90 minutes at 32 ± 1 °C in a horizontal position

Number of animals or in vitro replicates:

Three

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Run / experiment:

replica 1

Value:

0.72

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

in vitro irritation score

Run / experiment:

replica 2

Value:

-2.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

in vitro irritation score

Run / experiment:

replica 3

Value:

-2.03

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

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

Test Group	IVIS	Mean IVIS	Relative Standard Deviation IVIS
Negative Control HBSS	1.91	2.18	30.52%
	1.69
	2.93
Substance	0.72	- 1.78	54.18%
	- 2.60
	- 2.03
Positive Control 20% imidazole solution	115.33	125.44	11.82%
	142.46
	118.53

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance showed no effects on the cornea of the in vitro bovine eye and the calculated mean IVIS was -1.78. Therefore the substance is considered to be a non-irritant to the eyes.

Executive summary:

In an in vitro opacity and permeability study employing bovine cornea, which were exposed to undiluted substance for 4 hours, opacity and permeability values were measured. There was a mean IVIS of -1.78 following the 4-hour exposure point. Resultantly, the substance is considered to be non-irritant to the eye and not expected to cause serious eye damage.