Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017 - ***

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

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)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid

EC Number:

701-164-2

IUPAC Name:

Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid

Test material form:

liquid: viscous

Details on test material:

Chemical registery number : 701-164-2
Chemical name : Reaction products of C16-18 (even numbered), C18 unsaturated alkylamines with C10-13 alkylbenzenesulfonic acid

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agreed by each registrant.

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

Placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were refrigerated on arrival and used within 24 hours of receipt.

Test system

Vehicle:

Hank's balanced salt solution

Amount / concentration applied:

0.75 mL

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

120 minutes

Number of animals or in vitro replicates:

Three corneas were also allocated to the test item.
Three corneas to the positive control item.
Three corneas to the negative control item.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Was rinsed three times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red.

SCORING SYSTEM:
In Vitro Irritancy Score = mean opacity value + (15 x mean permeability OD492 value)

IVIS Classification
<= 3 No category. Not requiring classification
>3; <=55 No prediction of eye irritation can be made
>55 Category 1, UN GHS or EU CLP Causes serious eye damage

TOOL USED TO ASSESS SCORE: Camspec Model M108 Spectrophotometer.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

0.9

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was classified as non-irritant.

Executive summary:

The In Vitro irritancy scores for the test material is 0.9. The In Vitro irritancy scores for the negative control is 1.5.

The In Vitro irritancy scores for the positive control is 43.4. The test material was classified as non-irritant.