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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:
weight of evidence
Study period:
06-Jul-2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles, but as surfactant should have been probably best been tested as 10% solution.
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Available data from Etheramine C13i are considered to be applicable for C10i-etheramine as well. The structure of Etheramine C13i only differs from that of Etheramine C10i, in that the alkyl chain is only 2 carbons longer. This only has limited effects on physical properties, whereas chemical behaviour, reactivity and metabolism are the same. With alkylamines in general, the corrosive properties tend to increase with shortening of the alkyl chain. Therefore the results obtained from Etheramine C13i are therefore also expected to be of similar severity for Etheramine C10i, but certainly not less severe. (See for more information endpoint summary Ch.7.1 Toxicokinetics)
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
06-Jul-2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles, but as surfactant should have been probably best been tested as 10% solution.
Justification for type of information:
Available data from Etheramine C13i are considered to be applicable for C10i-etheramine as well. The structure of Etheramine C13i only differs from that of Etheramine C10i, in that the alkyl chain is only 2 carbons longer. This only has limited effects on physical properties, whereas chemical behaviour, reactivity and metabolism are the same. With alkylamines in general, the corrosive properties tend to increase with shortening of the alkyl chain. Therefore the results obtained from Etheramine C13i are therefore also expected to be of similar severity for Etheramine C10i, but certainly not less severe.
Qualifier:
according to
Guideline:
other: OECD guideline 437 “Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants”
Deviations:
no
GLP compliance:
yes (incl. certificate)
Vehicle:
physiological saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea

POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 10% (w/v) Benzalkonium Chloride
Duration of treatment / exposure:
- Exposure: 10 minutes
- Post incubation period: 120 minutes
Details on study design:
TEST SITE
- Isolated bovine cornea; triplicate per treatment.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- After the 10 minutes exposure and washing step, the corneas were incubated for 120 +/- 10 minutes at 32 °C. After the completion of the incubation period opacity determination was performed.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).


TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean
Value:
82
Negative controls validity:
valid
Positive controls validity:
valid

The corneas were turbid after the 10 minutes of treatment with 3-(Isotridecyloxy)-1-propane amine

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
3-(Isotridecyloxy)-1-propane amine is severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.
Executive summary:

This report describes the ocular irritation properties of 3-(lsotridecyloxy)-1-propane amine on an isolated bovine cornea. The possible ocular irritancy of 3-(lsotridecyloxy)-1-propane amine was tested through topical application for 10±1 minutes. The study procedures described in this report were based on the most recent OECD guideline.

 

3-(lsotridecyloxy)-1-propane amine was a clear colourless liquid with a purity of 95.8%m/m(NMR). The test substance was applied as it is (750 µL) directly on top of the corneas.

The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10%(w/v) Benzalkonium Chloride) was 138 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

 

3-(lsotridecyloxy)-1-propane amine induced severe ocular irritation through both endpoints, resulting in a meanin vitroirritancy score of 82 after 10 minutes of treatment.

 

Since 3-(lsotridecyloxy)-1-propane amine induced an IVIS ≥ 55.1, it is concluded that 3-(lsotridecyloxy)-1-propane amine is corrosive or severe irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guideline 437 “Bovine corneal opacity and permeability (BCOP) test method for identifying ocular corrosives and severe irritants”
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-(Isotridecyloxy)-1-propane amine
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the dark
- Purity: 95.8%
- Lot/batch No.: S001287
- Expiration date of the lot/batch: 30 April 2018
- pH: 11

Test system

Vehicle:
physiological saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 750 µl of physiological saline per cornea

POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 10% (w/v) Benzalkonium Chloride
Duration of treatment / exposure:
- Exposure: 10 minutes
- Post incubation period: 120 minutes
Details on study design:
TEST SITE
- Isolated bovine cornea; triplicate per treatment.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 10 minutes

SCORING SYSTEM:
- After the 10 minutes exposure and washing step, the corneas were incubated for 120 +/- 10 minutes at 32 °C. After the completion of the incubation period opacity determination was performed.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:

In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).


TOOL USED TO ASSESS SCORE:
- opacitymeter and microplate reader

DATA EVALUATION:
A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean
Value:
82
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

The corneas were turbid after the 10 minutes of treatment with 3-(Isotridecyloxy)-1-propane amine

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
3-(Isotridecyloxy)-1-propane amine is severe irritant or corrosive in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.
Executive summary:

This report describes the ocular irritation properties of 3-(lsotridecyloxy)-1-propane amine on an isolated bovine cornea. The possible ocular irritancy of 3-(lsotridecyloxy)-1-propane amine was tested through topical application for 10±1 minutes. The study procedures described in this report were based on the most recent OECD guideline.

 

3-(lsotridecyloxy)-1-propane amine was a clear colourless liquid with a purity of 95.8%m/m(NMR). The test substance was applied as it is (750 µL) directly on top of the corneas.

The negative control responses of the opacity and permeability values were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10%(w/v) Benzalkonium Chloride) was 138 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.

 

3-(lsotridecyloxy)-1-propane amine induced severe ocular irritation through both endpoints, resulting in a meanin vitroirritancy score of 82 after 10 minutes of treatment.

 

Since 3-(lsotridecyloxy)-1-propane amine induced an IVIS ≥ 55.1, it is concluded that 3-(lsotridecyloxy)-1-propane amine is corrosive or severe irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.