1-hydroxyoctan-2-one

Endpoint summary

Description of key information

Skin Irritation/Corrosion

In vitro assessment of the skin irritation potential of 1 -hydroxyoctan-2 -one was performed according to OECD guideline TG439:In vitroSkin Irritation: Reconstructed Human Epidermis (RHE) Test Method.This in vitro assay predicts the skin irritation potential of a chemical by measurement of its cytotoxic effect on the EpiDerm™ tissue model.The test item is applied directly to the skin surface, providing a good model of “real life” exposure. Cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from the skin tissues. Irritant test items are identified by their ability to decrease cell viability below defined threshold levels (below or equal to 50% for UN GHS Category 2). If the viability is greater than 50%, the test item is classified as Non-Irritant (no-label).

Prior to the execution of the study, the required compatibility checks confirmed that the test item interfered with MTT. Therefore, additional freeze killed tissues were included in order to determine if any direct reduction of MTT had taken place during the main study. No water colouration was observed.

The percentage of viability obtained with the test item 1 -hydroxyoctan-2 –one was 4.834%, therefore it was considered as Irritating to the skin.

Eye Irritation/Corrosion

In vitro Experimental Test Data for the Registration Substance

In vitro Assessment of the eye irritation potential of 1 -hydroxyoctan-2 -one according to OECD guideline TG492 (Reconstructed human Cornea-like Epithelium [RhCE] test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage). The test item is applied directly to the cornea surface, providing a good model of “real life” exposure

 

This in vitro assessment assay predicts the acute eye irritation potential of a chemical by measurement of its cytotoxic effect on the EpiOcular™ corneal epithelial model. Cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from the skin tissues. Irritant test items are identified by their ability to decrease cell viability below defined threshold levels (below or equal to 60% for eye irritants ). If the viability is greater than 60%, the test item is classified as Non-Irritant (“no-label”, or UN GHS No Category).

 

The percentage of viability obtained with test item 1 -hydroxyoctan-2 -one was 12.571%, therefore no prediction can be made

Weight of Evidence (WoE) Assessment to Conclude on Skin and Eye Irritation using Read-Across Analogue Data

Skin Irritation

In vivo (guinea pig) study data is available for the read-across source substance octan-2 -one (Sharp, 1978). In this study, no signs of erythema and edema were observed at 1.0% ICC and 10% ACC concentrations. Hence, the test chemical was considered to be non-irritating on guinea pigs in the preliminary irritation tests performed for the sensitization study.

However, in the in vitro skin irritation study 1 -hydroxyoctan-2 -one was found to be irritating to skin which is in conflict with the (non-guideline) in vivo data available for the structurally analagous substance octan-2 -one. It is reasonable to conclude based on the available data that 1 -hydroxyoctan-2 -one will not be corrosive to skin, hence classification as GHS category 2 (H315) for skin irritation effects is proposed.

Eye Irritation

Two non-guideline acute inhalation studies in the guinea pig and rat for the structurally analagous read-across source substance octan-2 -one are available in the open scientific literature. Both studies conclude the substance to have mild irritation effects on the eye. A third read-across OECD 405 eye irritation study is available in the published literature for the read-across substance octan-1 -ol and the results of which warrant classification of the substance as eye irritant category 2 (H319).

Therefore, using a WoE approach based on experimental in vitro data and read-across analogues, the target/registration substance 1 -hydroxyoctan-2 -one is considered to be mildly irritating to the eye, warranting classification as GHS Category 2 (H319).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15-19 January 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

This is a Klimisch 1 OECD 439 guideline study conducted on the registered substance 1-hydroxyoctan-2-one in accordance GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch 1081-67E

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Justification for test system used:

Initially the predictive capacity of the modified EpiDerm'M Skin Irrit ation Test (SIT) test method, using MatTek EpiDerm™ tissue model EPI-200, underwent full prospective validation from 2003-2007. The test method components of this method were used to define the essential test methods components of the original and updated ECVAM Performance Standards (PS).

A modification of the original EpiDerm'M SIT was validated using the original ECVAM PS in 2008. In 2008, ESAC concluded that the Modified EpiDerm'M SIT has sufficient accuracy and reliability for prediction of R38 skin irritating and no-label (non-skin irritating) test substances.

Vehicle:

unchanged (no vehicle)

Details on test system:

The reconstructed human epidermal model EpiDermTM (EPI-200-MatTek Corporation) consists of normal human-derived epidermal keratinocytes which have been cultured to form a multi-layered highly differentiated model of the human epidermis. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

A single topical application of 30 µl of neat test item, negative control (DPBS) or positive control (SDS 5%) was applied to the surface of EpiDerm™ model

Duration of treatment / exposure:

60 ± 1 minute (25 minutes at room temperature and 35 minutes at 37"C, 5% C02, ≥95% RH)

Duration of post-treatment incubation (if applicable):

42 ± 4h post-treatment incubation, prior to the MTT endpoint

Number of replicates:

Three tissues per condition (Negative Control, Positive Control and Test Item)

Irritation / corrosion parameter:

% tissue viability

Remarks:

Corrected for freeze killed control tissues

Run / experiment:

1

Value:

4.834

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Irritation / corrosion parameter:

% tissue viability

Remarks:

Uncorrected for freeze killed control tissue

Run / experiment:

1

Value:

8.946

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

The viability of the MTT Interference Control (Freeze Killed Tissues) was 4.112%. Therefore, this value was subtracted from the uncorrected result of 8.946 %viability to yield the corrected result of 4.834% viability.

Viability measurements after 60 min (± 1min) of application and 42h (± 4h) post-incubation of test and reference items and controls.

Condition	Tissue #	Raw data		Blank corrected data		Mean OD	% of Viability
		Aliquot 1	Aliquot 2	Aliquot 1	Aliquot 2
NC	Tissue 1	1.767	1.749	1.611	1.593	1.602	106.681
	Tissue 2	1.556	1.55	1.400	1.394	1.397	93.030
	Tissue 3	1.662	1.662	1.506	1.506	1.506	100.289
PC	Tissue 1	0.258	0.238	0.102	0.082	0.092	6.127
	Tissue 2	0.21	0.217	0.054	0.061	0.058	3.829
	Tissue 3	0.2	0.209	0.044	0.053	0.049	3.230
TA1	Tissue 1	0.274	0.264	0.118	0.108	0.113	7.525
	Tissue 2	0.311	0.31	0.155	0.154	0.155	10.289
	Tissue 3	0.291	0.292	0.135	0.136	0.136	9.023

NC: negative control (DPBS), PC: Positive control (SDS 5%), TA1: Test Item

Mean and SD of cell viability measurements and of viability percentages after 60 min (± 1min) of application and 42h (± 4h) post-incubation.

Name	Code	Mean of OD	SD of OD	Mean of viability (%)	SD of viability (%)	CV %	Classification
DPBS	NC	1.502	0.103	100.000	6.830	6.830	Non-Irritant
SDS 5%	PC	0.066	0.023	4.395	1.529	34.791	Irritant
EXPINN PC17032	TA1	0.134	0.021	8.946	1.383	15.465	Irritant

NC: Negative control (DPBS), PC: Positive control (SDS 5%), TA1: Test Item.

Prediction model of irritancy: test items that reduce the viability to 50% or below are irritant (I), test items with a percentage viability above 50% are considered to be non-irritant (NI).

Mean % viabilities obtained from additional tests to correct for MTT interference.

Test Item	MTT Interference Control (FK): % viability	Initial % Viability	Corrected % Viability
TA1	4.112	8.946	4.834

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The percentage of viability obtained with the test item was 4.834%, therefore it was considered as Irritant to the skin.

Executive summary:

In vitro assessment of the skin irritation potential of 1 -hydroxyoctan-2 -one was performed according to OECD guideline TG439:In vitroSkin Irritation: Reconstructed Human Epidermis (RHE) Test Method.This in vitro assay predicts the skin irritation potential of a chemical by measurement of its cytotoxic effect on the EpiDerm™ tissue model.The test item is applied directly to the skin surface, providing a good model of “real life” exposure. Cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from the skin tissues. Irritant test items are identified by their ability to decrease cell viability below defined threshold levels (below or equal to 50% for UN GHS Category 2). If the viability is greater than 50%, the test item is classified as Non-Irritant (no-label).

Prior to the execution of the study, the required compatibility checks confirmed that the test item interfered with MTT. Therefore, additional freeze killed tissues were included in order to determine if any direct reduction of MTT had taken place during the main study. No water colouration was observed.

The percentage of viability obtained with the test item 1 -hydroxyoctan-2 –one was 4.834%, therefore it was considered as Irritating to the skin.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Octan-2-one (source substance for read-across) is a close structural analogue of the registration/target substance 1-hydroxyoctan-2-one and is thus expected to exhibit similar skin irritation properties. Data is from a peer reviewed journal

Qualifier:

according to guideline

Guideline:

other: as described below

Deviations:

not specified

Principles of method if other than guideline:

Preliminary skin irritation tests were performed in guinea pigs to determine the concentration for the sensitization study

GLP compliance:

not specified

Specific details on test material used for the study:

Name of test material (as cited in study report): 2 octanone
Molecular formula : C8H16O
Molecular weight:128.2134 g/mol
Substance type: Organic
Physical State: Liquid

Species:

guinea pig

Strain:

Hartley

Details on test animals or test system and environmental conditions:

- Sex: Male/female
- Weight at study initiation: 450 g
- Housing: Housed in wire mesh cages in pairs of the same sex
- Diet (e.g. ad libitum): Pelleted guinea pig diet, cabbage and hay ad libitum
- Water (e.g. ad libitum): water ad libitum

Type of coverage:

open

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

0.1 ml (Intradermal Concentration)

Duration of treatment / exposure:

24 hours

Observation period:

24 hours

Number of animals:

4 guinea pigs (same sex)

Details on study design:

TEST SITE
- Area of exposure:
Intradermal – shaved flanks
Topical - small circular areas on the clipped, shaved flanks

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

No irritation observed in the preliminary skin sensitization testing

SENSITIZATION POTENTIAL OF SYNTHETIC PERFUME INGREDIENTS

Non-sensitizer = no evidence of sensitization

Test chemical	ICC(%)	ACC(%)	Results
111 -13 -71.0	1.0	10	Not sensitizer

Interpretation of results:

other: Not irritiating

Conclusions:

No signs of erythema and edema were observed at 1.0% ICC and 10% ACC concentrations. Hence, the test chemical was considered to be non-irritating on guinea pigs in the preliminary irritation tests performed for the sensitization study

Executive summary:

Preliminary irritation tests were performed for the test chemical in guinea pigs to determine the concentration suitableforthe sensitization study[injection challenge concentration (ICC) and application challenge concentration(ACC)].

                        

In the preliminary irritation study, 4 Albino Hartley guinea pigs of the same sexwereinjected intradermally on the shaved flanks with 0.1 ml aliquots of a range of concentrations of tests material in a suitable solvent. The reactions were examined for size (two largest diameters), erythema and oedema 24 h later and the concentration giving slight but perceptible irritationwith no oedema was selected as the injection challenge concentration (ICC).0.1 ml of the test material in arange of concentrations in a suitable solvent were applied in small circular areas to the shaved flanks of 4 guinea pigs of the same sex.The reactions were examined for erythema 24 hours later and the highest concentration which caused no irritation was selected as the application challenge concentration (ACC).

No signs of erythema and edema were observed at 1.0% ICC and 10% ACC concentrations. Hence, the test chemical was considered to be non-irritating on guinea pigs in the preliminary irritation tests performed for the sensitization study.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16-25 Jan 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

This is a Klimisch 1 OECD 492 guideline study conducted on the registered substance 1-hydroxyoctan-2-one in accordance GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch 1081-67E

Species:

human

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

After pre-wetting tissues with 20 µl PBS (Sterile Dulbecco's Phosphate Buffered Saline) for 30 ± 2 min, a single topical application of 50 µl of neat test item or of reference items was applied to the surface of the EpiOcular™ models for 30 minutes ± 2 minutes

Duration of treatment / exposure:

30 minutes ± 2 minutes

Duration of post- treatment incubation (in vitro):

12 ± 2 minute post-treatment immersion, and 2 hours ± 15 minutes post-treatment incubation, prior to the MTT endpoint

Number of animals or in vitro replicates:

Three tissues per condition (n=3)

Details on study design:

Prior to the study, the required compatibility checks confirmed that the test item interfered with MTT and therefore freeze killed controls (to assess direct MTT reduction) were included in the main test. There was no interference with the assay solvent.

Irritation parameter:

other: %viability

Remarks:

Corrected for freeze killed tissue control

Run / experiment:

1

Value:

12.571

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable

Irritation parameter:

other: % tissue viability

Remarks:

Uncorrected for freeze killed tissue control

Run / experiment:

1

Value:

17.498

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

not determinable

Other effects / acceptance of results:

The viability of the MTT Interference Control (Freeze Killed Tissues) was 4.927%. Therefore, this value was subtracted from the uncorrected result of 17.498% tissue viability to yield the corrected result of 12.571% tissue viability

Viability measurements after 30 minutes (± 2 min) of application and 2h (± 15 min) post-incubation of test and reference items.

Condition	Tissue #	Raw data		Blank corrected data		Mean OD	% of viability
		aliquot 1	aliquot 2	aliquot 1	aliquot 2
NC	Tissue 1	2.145	2.159	1.977	1.991	1.984	102.347
	Tissue 2	2.085	2.092	1.917	1.924	1.920	99.071
	Tissue 3	2.093	2.065	1.925	1.897	1.911	98.581
PC	Tissue 1	1.25	1.226	1.082	1.058	1.070	55.193
	Tissue 2	0.889	0.905	0.721	0.737	0.729	37.601
	Tissue 3	0.784	0.779	0.616	0.611	0.613	31.642
TA1	Tissue 1	0.538	0.527	0.370	0.359	0.364	18.796
	Tissue 2	0.521	0.52	0.353	0.352	0.352	18.177
	Tissue 3	0.47	0.468	0.302	0.300	0.301	15.520

NC: negative control (sterile H₂O), PC: Positive control (neat Methyl Acetate), TA1: test item

Mean and SD of viability measurements and of viability percentages after 30 minutes (± 2 min) of application and 2h (± 15 min) post-incubation.

Name	Code	mean of OD	SD of OD	Mean of viability (%)	SD of viability (%)	CV %	Classification
Sterile water	NC	1.938	0.040	100.000	2.05	2.048	No Category
Methyl Acetate	PC	0.804	0.237	41.479	12.245	29.521	No prediction
EXPINN PC17032	TA1	0.339	0.034	17.498	1.740	9.947	No prediction

Mean % viabilities obtained from additional tests to correct for MTT interference

Test Item	MTT Interference Control (FK): % viability	Initial % Viability	Corrected % Viability
TA1	4.927	17.498	12.571

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The percentage of viability obtained with test item 1 -hydroxyoctan-2 -one was 12.571%, therefore no prediction can be made

Executive summary:

In vitro Assessment of the eye irritation potential of 1 -hydroxyoctan-2 -one according to OECD guideline TG492 (Reconstructed human Cornea-like Epithelium [RhCE] test method for identifying chemicals not requiring classification and labelling for eye irritation or serious eye damage). The test item is applied directly to the cornea surface, providing a good model of “real life” exposure

 

This in vitro assessment assay predicts the acute eye irritation potential of a chemical by measurement of its cytotoxic effect on the EpiOcular™ corneal epithelial model. Cell viability is measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that is quantitatively measured after extraction from the skin tissues. Irritant test items are identified by their ability to decrease cell viability below defined threshold levels (below or equal to 60% for eye irritants ). If the viability is greater than 60%, the test item is classified as Non-Irritant (“no-label”, or UN GHS No Category).

 

The percentage of viability obtained with test item 1 -hydroxyoctan-2 -one was 12.571%, therefore no prediction can be made

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2006

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Octan-2-one (source substance for read-across) is a close structural analogue of the registration/target substance 1-hydroxyoctan-2-one and is thus expected to exhibit similar eye irritation properties.

Qualifier:

equivalent or similar to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the ocular irritation potential of the test chemical

GLP compliance:

not specified

Specific details on test material used for the study:

Name of test material (as cited in study report): 2 octanone
Molecular formula : C8H16O
Molecular weight:128.2134 g/mol
Substance type: Organic
Physical State: Liquid

Species:

rat

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data available

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

8.9 mg/l (1673 ppm)

Duration of treatment / exposure:

6 hours

Observation period (in vivo):

6 hours

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

no data available

Details on study design:

no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 6 hours

Reversibility:

not specified

Remarks on result:

probability of mild irritation

Remarks:

Mild Irritation Observed

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The close structural analogue source substance 2 -octanone is considered to be a mild eye irritant

Executive summary:

Rats exposed to calculated vapor concentrations of the close structural analogue source substance 2 -octanone @ 8.9 mg/L (1673 ppm) for 6 hr exhibited signs of mild eye irritation.

Hence, the octan-2 -one is considered to be mildly irritating to rat eyes and by extension of the read-across principle the registration substance 1 -hydroxyoctan-2 -one is also considered irritating to the eyes

Reference 3

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Octan-2-one (source substance for read-across) is a close structural analogue of the registration/target substance 1-hydroxyoctan-2-one and is thus expected to exhibit similar eye irritation properties.

Qualifier:

equivalent or similar to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

To assess the ocular irritation potential of 2-octanone in guinea pigs

GLP compliance:

not specified

Specific details on test material used for the study:

Name of test material (as cited in study report): 2 octanone
Molecular formula : C8H16O
Molecular weight:128.2134 g/mol
Substance type: Organic
Physical State: Liquid

Species:

guinea pig

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data available

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

Saturated vapors (1300 ppm)

Duration of treatment / exposure:

12 hours

Observation period (in vivo):

12 hours

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

no data available

Details on study design:

no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 12 hours

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

irritation was observed immediately after exposure to 2-octanone

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Symptoms of eye irritation developed immediately after the guinea-pig was exposed to an essentially saturated atmosphere (1300 ppm) of the close structural analogyue source substance 2-octanone.
Hence, 2-octanone can be considered as irritating to eyes.

Executive summary:

In an acute inhalation study, guinea pigs were exposed toan essentially saturated atmosphere (1300 ppm) of the close structural analogue substance 2-octanone. Symptoms of eye irritation developed immediately after exposure.

Hence, 2-octanone can be considered as irritating to eyes and by extension of the read-across principle the registration substance 1 -hydroxyoctan-2 -one is also considered irritating to the eyes

Reference 4

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed information

Justification for type of information:

Octananol (source substance for read-across) is a close structural analogue of the registration/target substance 1-hydroxyoctan-2-one and is thus expected to exhibit similar eye irritation properties.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Undiluted (neat)
Ammount applied: 0.1 ml

Observation period (in vivo):

96h

Number of animals or in vitro replicates:

6

Details on study design:

Comment: not rinsed

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

2.23

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 96h

Score:

2

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Remarks on result:

probability of weak irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 96h

Score:

0.5

Remarks on result:

probability of weak irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.57

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 96h

Score:

2

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.9

Remarks on result:

probability of moderate irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 96h

Score:

1

Remarks on result:

probability of moderate irritation

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

1-octanol is considered a Category 2A eye irritant. 

Executive summary:

The read-across source substance 1-octanol is an eye irritant according to EU criteria based on a mean 24+48+72 hour score for 6 rabbits of 2.57 for conjuctivitis and 2.23 for corneal opacity. Results are only given up to 96 hours post instillation but the evidence was that the effects were reversing at this time point. Lack of individual scores precludes accurate assessment by GHS however based on the mean scores of 6 rabbits for corneal opacity of 2.23 and for iritis of 0.7 and given the evidence of reversibility 1-octanol is considered a Category 2A eye irritant. 

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

On the basis of the available information, the registration substance 1 -hydroxyoctan-2 -one is classified as skin irritant category 2 (H315) and eye irritant category 2 (H319).