3-methyl-1,3-butanediol-1-ethylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

14 June 2021 to 3 September 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 491 (Short Time Exposure In Vitro 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:

26 June 2020

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-1,3-butanediol-1-ethylate

EC Number:

816-856-0

Cas Number:

5205-01-6

Molecular formula:

C7H14O3

IUPAC Name:

3-methyl-1,3-butanediol-1-ethylate

Specific details on test material used for the study:

86.0% purity
IDP-AC
CAS 5205-01-6

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Remarks:

Rabbit cornea (SIRC) cells

Details on test animals or tissues and environmental conditions:

Mycoplasma negative rabbit cornea (SIRC) cells specified in the OECD test guideline were obtained from Health Science Research Resources Bank, Japan Health Sciences Foundation. The doubling time was 18-31 hours. Cells were stored frozen in liquid nitrogen, in medium containing 10% FBS and 10% DMSO. The cell passage number was 14-16 for the three experiments.

Test system

Vehicle:

physiological saline

Remarks:

5% w/w

Controls:

yes, concurrent no treatment

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

200 microlitres/well
5% (w/w)
0.05% (v/v)

Duration of treatment / exposure:

5 minutes

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

The test material, solvent and positive controls were tested in triplicate.

Details on study design:

- Number of repetitions and replicates used:
The assay was perforemd in triplicate with three independent valud repetitions. An inititial repetition was discounted as it did not meet the acceptance criteria for the positive control.

- Test chemical concentrations used:
5% (w/w), 0.055 (v/v), as specified by the OECD Test Guideline

- Justification for choice of solvent for each test chemical
Based on solubility of the test material and positive control chemicals, and compatability with the test system.

- Duration of exposure to the test chemical:
5 minutes, as specified by the OECD Test Guideline

- Description of any modifications of the test procedure:
None

- Description of evaluation and decision criteria used
Acceptability criteria:
Mean OD in the medium control group >=0.3
Cell viability of the negative control >=80% of the medium control
Cell viability of the positive control 21.1-62.3%
SD for the mean final cell viability <15% for both test material concentrations

Decision criteria:
Category 1 is assigned on the basis of mean cell viability (5% or 0.05%) <=70%
No prediction can be made on the basis of mean cell viability <=70% (5%) and >70% (0.05%)
Category 2 is assigned on the basis of mean cell viability (5% or 0.05%) >70%

- Reference to historical positive control data:
Included in the study report

- Demonstration of proficiency of the laboratory in performing the test method:
Included in the study report

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

percent tissue viability 

Remarks:

(%)

Run / experiment:

Runs 2-4 (0.05% test material)

Value:

>= 90.4 - <= 114.9

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

percent tissue viability 

Remarks:

(%)

Run / experiment:

Runs 2-4 (5% test material)

Value:

>= 65.8 - <= 92.6

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

All acceptance criteria were met for the three independent experiments presented. An initial experiment was rejected.

Any other information on results incl. tables

Summary of results

Group	Experiment #	Viability (%)		Mean (%)	SD (%)
Medium control	2	100.0
	3	100.0
	4	100.0
Negative control	2	97.3	100.0	96.8	5.1
	3	91.5	100.0
	4	101.7	100.0
Positive control	2		38.7	47.2	9.0
	3		56.6
	4		46.3
5%	2		65.8	76.9	13.9
	3		72.5
	4		92.6
0.05%	2		90.4	104.3	12.6
	3		107.8
	4		114.9

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

The results of this study indicate that IPD-AC does not require classification in any GHS Category for eye irritation.

Conclusions:

The results of this study indicate that IPD-AC does not require classification for eye irritation according to CLP criteria.

Executive summary:

The ability of the test material IPD-AC to cause serious eye damage or serious eye irritation was investigated in a short-term exposure (STE) assay in rabbit cornea SIRC cells, performed to GLP and OECD TG 491.  The mean cell viabilities over the three independent experiments were 76.9% (5% w/w) and 104.3% (0.05% v/v).  The results of this study indicate that IPD-AC does not require classification for eye irritation according to CLP criteria.