Registration Dossier

Administrative data

Description of key information

Skin corrosion: not corrosive in absence of skin and eye irritation

Skin irritation: not irritating based on read across from Musk T (tested in an OECD TG 404)

Eye irritation: not irritating based on read across from Habanolide (tested in an OECD TG 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across information.
Justification for type of information:
The information is derived from the skin irritation from Musk T. The read across rationale is presented in the Irritation Endoint summary, the accompanying files are also attached there.
Reason / purpose:
read-across source
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects were seen at all
Remarks on result:
other: read-across from Musk T
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects were seen at all
Remarks on result:
other: read-across from Musk T
Interpretation of results:
other: Not a skin irritant
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
Slight dose related skin erythema 1 hour after termination of exposure is determined. Thereafter, no abnormalities were observed. The substance is not a skin irritant, based on the results of the source substance.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
between 12-12-1994 and 15-12-1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The information is used for read across to Oenanthic ether
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Scantox A/S, Hestehavevef 36A, Ejby, 4623 LI, Skensved, Danmark
Species:
rabbit
Strain:
other: SPF albino rabbits
Details on test animals and environmental conditions:
Four female SPF albino rabbits weighing 2.0 - 2.1 kg of the stock Mol:Russian from Møllegaard Breeding and Research Centre AJS, Ejby, DK-4623 Lille Skensved were used.
The animals were earmarked on arrival with National Wing Bands. The study took place in animal room No. 1 provided with filtered air with a temperature of 21°C ± 3°C, relative humidity of 55% ± 15% and air changes 10 times/hour. The room was illuminated to give a 24 hour cycle of 12 hours light and 12 hours darkness. Light was on from 6 a.m. to 6 p.m.
During a pre-period of at least 1 week and throughout the experiment the rabbits were caged in single 62 x 52 cm PPO cages with perforated floor.
Diet: A pelleted complete rabbit diet “Altromin 2123” from Chr. Petersen, DK-4100 Ringsted, was available ad libitum. Analyses for major nutritive components and significant contaminants are performed regularly on the diet. Certificates of analysis are retained.
Drinking water: The animals had free access to bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth.
Analyses for possible contaminants are performed regularly. Certificates of analysis are retained.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: Ethanol 96% and diethyl phthalate (DEP)
Controls:
no
Amount / concentration applied:
100%, 20% (w/w), 10% (w/w), 5% (w/w), 1% (w/w).
Ethanol 96% and diethyl phthalate (DEP) in a ratio 1 : 1 (w/w).
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 28, 72 hours after termination of exposure
Number of animals:
4 female SPF albino rabbits
Details on study design:
The day before the experiment was started the rabbits were weighed and an area of 10 x 10 cm on the back was clipped as closely as possible with an electric clipper.
On the experimental day the rabbits were physically restrained on a test table, and the clipped area was divided into 6 test sites: 2 anterior located test sites, 2 centrally located test sites and 2 posterior located test sites. To each of 6 gauze patches (2.5 x 2.5 cm) 0.5 ml of 1 of the test concentrations or the vehicle was applied and the patches were placed on the appropriate test site at the back of each rabbit. The gauze patches were secured with a semi-occlusive dressing by means of a 1 cm wide adhesive tape and fixed with Scanpor tape, 4.5 cm width, loosely wound round the trunk. The application schedule was made by a computerized randomization programme and the 5 different test concentrations and the vehicle were applied as follows:
Rabbit No. 7499 7500 7501 7502
A.L A.R. 100% 20% V 5% V 10% 100% 5%
M.L M.R 10% 5% 20% 1% 100% 20% 1% 20%
P.L P.R. 1% V 10% 100% 5% 1% 10% V

A.L: Anterior left treatment site P.L.: Posterior left treatment site
A.R.: Anterior right treatment site P.R.: Posterior right treatment site
M.L.: Mid-left treatment site V: Vehicle
M.R.: Mid-right treatment site

After an exposure time of 4 hours the tape and patches were removed and the treated skin was cleaned with soap and lukewarm water. The skin reactions were read 1 hour later according to the following scale:
Erythema and Eschar Formation: No erythema: 0; Very slight erythema (barely perceptible): 1; Well-defined erythema: 2; Moderate to severe erythema: 3; Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4.
Oedema Formation: No oedema: 0; Very slight oedema (barely perceptible): 1; Slight oedema (edges of area well-defined by definite raising): 2; Moderate oedema (raised approximately 1 mm): 3; Severe oedema (raised more than 1 mm, extending beyond area of exposure): 4.

Reading was also made 24, 48 and 72 hours after termination of exposure. The scores for erythema and oedema formation for the 3 readings 24, 48 and 72 hours of each rabbit for each test concentration were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation of the individual rabbit for each test concentration.
The mean scores for erythema and oedema formation in the 4 rabbits used for each concentration tested were subsequently calculated.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects were seen at all
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects were seen at all
Irritant / corrosive response data:
Slight dose related (100%, 20% and 10% test concentrations) skin erythema was observed 1 hour after termination of exposure. Thereafter no abnormalities were observed.
The mean scores were as follows:
Erythema: 0.0 (100%), 0.0 (20%), 0.0 (10%), 0.0 (5%), 0.0 (1%), 0.0 (Vehicle)
Oedema: 0.0 (100%), 0.0 (20%), 0.0 (10%), 0.0 (5%), 0.0 (1%), 0.0 (Vehicle)
Other effects:
no
Interpretation of results:
other: Not a skin irritant
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
Based on the results of an OECD guideline 404 study conducted in compliance with GLP, the test substance is considered to be not irritating to the skin.
Executive summary:

In a skin irritation study performed in accordance with GLP and OECD guideline 404 (Scantox A/S, 1994), four albino rabbits were exposed semi-oclusive to 5 different concentrations (100, 20, 10, 5, and 1% w/w) of the test substance at 6 skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Slight dose related (100%, 20% and 10% test concentrations) skin erythema was observed 1 hour after termination of exposure. Thereafter, no abnormalities were observed. The test substance was found not to be skin irritant when applied topically to the rabbit.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across information.
Justification for type of information:
The information is derived from Habanolide. The read across rationale is presented in the Irritation Endpoint summary. The accompanying files are also attached there.
Reason / purpose:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
chemosis score
Basis:
animal: # 2
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Interpretation of results:
other: Not an eye irritant
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
Oenanthic ether is not an eye irritant based on read across from Habanolide, which was tested in an OECD TG 405 test.
Endpoint:
eye irritation: in vivo
Remarks:
An in vivo study from before 2016 is used for asssessing eye irritation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1991-12-10 to 1991-12-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The information is used for read across to Oenanthic ether.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex - England
- Age at study initiation: not mentionned in the study report
- Weight at study initiation: 2.7, 3.4, 2.8 & 3.2 kg
- Housing: The animals were individually housed in grid bottomed metal cages.
- Diet: Free access to antibiotic-free pelleted diet, SQC Stanrab (Special Diets Services, Witham, Essex). (Quality checked)
- Water: Free access via an automatic watering system were freely available. (Quality checked)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 22°C (On 3 occasions the temperature fell below the protocol specified range, the temperature of 15°C being recorded on only one of these occasions. These deviations were considered not to have affected the outcome of the study)
- Humidity (%): 37 to 59%
- Air changes (per hr): not mentioned in the study report
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 Dec 1991 2004 To: 20 Dec 1991
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for a few second immediately after treatment, to prevent loss of the test material, and then released. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. One rabbit was dosed initially to assess the severity of irritation or pain. As the response to treatment was considered acceptable the remaining three animals were then dosed.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. An assessment of the initial pain reaction was made immediately after administration of the test material.
Number of animals or in vitro replicates:
4
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: NA

TOOL USED TO ASSESS SCORE: animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour).
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no changes were recorded
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1 h
Score:
>= 1 - <= 2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
chemosis score
Basis:
animal: # 2
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: signs of irritation as observed at 1 hour after exposure were no longer apparent.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no changes were recorded
Irritant / corrosive response data:
One hour after dosing, conjunctival discharge and hyperaemia was apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods.
Other effects:
None
Interpretation of results:
other: Not an eye irritant
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
In an OECD guideline 405 study conducted in compliance with GLP, the test substance is considered to be not irritating to the eye.
Executive summary:

In an eye irritation study performed according to GLP and OECD guideline 405, 0.1 ml of the test substance was instilled into one eye of each of four rabbits. The animals were then observed for seven days. One hour after dosing, conjunctival discharge and hyperaemia were apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods. As such, the substance does not need to be classified for eye irritation.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin corrosion is derived from absence of skin and eye irritation. Skin and eye irritation potential of Oenanthic ether is based on read-across from Musk T and Habanolid, respectively. The executive summaries of Musk T and Habonolide are presented first followed by the read-across rationale.

 

Musk T Skin irritation

The primary skin irritant effect of MuskT was investigated in a study performed in accordance with GLP and OECD guideline 404. Four albino rabbits were exposed semi-occlusively to 5 different concentrations (1, 5, 10, 20 and 100% w/w) of Musk T at 6 skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Slight dose related (10%, 20% and 100% test concentrations) skin erythema was observed 1 hour after termination of exposure. Thereafter, no abnormalities were observed. MuskT was not irritant to skin.

 

Habanolide Eye irritation

In a GLP-compliant eye irritation study performed according to OECD guideline 405, 0.1 ml Habanolide was instilled into one eye of each of four rabbits. The animals were then observed for seven days. One hour after dosing, conjunctival discharge and hyperaemia were apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods. Habanolide was not irritant to eyes.

The skin and eye irritation properties of Oenanthic Ether using read across from Musk T (CAS 105-95-3) and Habanolide (CAS 34902-57-3, 111879-80-2)

 

Introduction and hypothesis for the analogue approach

Oenanthic ether consists of 3 main constituents and a number of impurities. All are ethyl esters, despite the name ether, of long chain carboxylic acids. The major constituent has a C12 chain, the two minor ones have C14 and C16 saturated carbon chain. For this substance there are no experimental skin or eye irritation data.

In accordance with Article 13 of REACH, lacking information can be generated by other means i.e. applying alternative methods such as QSARs, grouping and read-across. For assessing the irritant properties of Oenanthic ether, the analogue approach is selected because for two closely related analogues Musk T and Habanolide skin and eye experimental information on irritant properties is available which can be used for read across.

Hypothesis: Oenanthic ether does not have skin and eye irritation based on absence of skin irritation in Musk T and absence of eye irritation in Habanolide.

Available information on skin irritation for Musk T: The primary skin irritant effect of MuskT was investigated in a study performed in accordance with GLP and OECD guideline 404. Four albino rabbits were exposed semi-occlusive to 5 different concentrations (1, 5, 10, 20 and 100% w/w) of Musk T at 6 skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Slight dose related (10%, 20% and 100% test concentrations) skin erythema was observed 1 hour after termination of exposure. Thereafter, no abnormalities were observed. MuskT was not a skin irritant.

Available information on eye irritation for Habanolide: In a GLP-compliant eye irritation study performed according to OECD guideline 405, 0.1 ml Habanolide was instilled into one eye of each of four rabbits. The animals were then observed for seven days. One hour after dosing, conjunctival discharge and hyperaemia were apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods. Habanolide was not an eye irritant.

Target chemical and source chemicals

Chemical structures of the target chemical and the source chemical(s) are shown in the data matrix, including physico-chemical properties and available toxicologicalinformation. Furthermore, a full list of constituents of Oenanthic ether, including information relevant for read-across, is given in Appendix 1.

Purity / Impurities

The purity and unidentified impurities of the target chemical and source chemical are not expected to influence the potential for skin and eye irritation.

Analogue approach justification

According to Annex XI 1.5 read across can be used to replace testing when the similarity can be based on a common backbone and a common functional group. When using read across the result derived should be applicable for C&L and/or risk assessment and it should be presented with adequate and reliable documentation, which is presented below.

Analogue selection: For Oenanthic ether Zenolide was the preferred analogue. For Zenolide, however, read across from Musk T was performed and therefore the information from Musk T is also used for Oenanthic ether. Musk T can be used as an analogue because it is a long-chain fatty acid with an ester bond for which skin irritation information is available. For Zenolide, Habanolide was used as an analogue for eye irritation and istherefore now used for Oenanthic ether. Habanolide can be used as an analogue because it is a long-chain fatty acid with an ester bond for which eye irritation information is available.

Structural similarities and differences:All constituents of Oenanthic ether contain long alkyl chain (C8-C18) similar to Musk T and Habanolide and all contain acetic type of ester bonds.

The key difference is that both Musk T and Habanolide are cyclic esters in combination with long alkane chains C13 and C15, respectively. Musk T has a double ester (being ethylene glycol-type ester), while Habanolide has a single ester. Habanolide also has one double bond in its alkyl chain. These minor differences are not affecting the skin and eye irritation properties.

Toxico-kinetics: Skin irritation results partly from the substance being absorbed when the substance does not have corrosive features. Dermal absorption of Oenanthic ether is expected to be similar to Musk T based on similarities in molecular weight, water solubility and log Kow. Eye irritation is also related to penetration of the eye protection layers by the substance. Oenanthic ether and Habanolide have similar features considering structure, molecular weight, as well as somewhat similar water solubility, an important parameter considering the solubilisation of the substance in the aqueous environment of the eye. These are not anticipated causing differences in eye irritation.

Toxico-dynamics, Reactivity:The reactive group is the ester bond in Oenanthic ether, in Musk T and in Habanolide. Musk T has a double ester and is therefore somewhat more reactive compared to Oenanthic ether and therefore the read across is ‘conservative’. Oenanthic ether and Habanolide will have the same reactivity. The additional double bond is not adjacent to the ester and therefore will not have another reactivity compared to the straight alkyl chain in Oenanthic ether.

Uncertainty of the prediction:There are no remaining uncertainties besides the ones which were discussed above and therefore the skin and eye irritation from Musk T and from Habanolide can be applied to Oenanthic ether.

Data matrix

The relevant information on physico-chemical properties and toxicological characteristics are presented in the data matrix below.

Conclusions per endpoint for hazard and risk assessment

For Oenanthic ether no skin and eye irritation information is available. Two analogues were found to fill this data gap. When using read acrossthe result derived should be applicable for C&L and/or risk assessment and be presented with adequate and reliable documentation. The present document fulfils this type of documentation. Musk T was not skin irritating in an OECDTG 404 test and Habanolide was not an eye irritant in an OECD TG 405 test. Based on the above reasoning Oenanthic ether is not corrosive and not a skin or eye irritant.

Final conclusion on hazard:Oenanthic ether is not corrosive and not a skin or eye irritant.

 

Data matrix for the read-across to Oenanthic ether from Musk T and Habanolide for skin and eye irritation, respectively

Chemical names for

 

Oenanthic ether#

ethyl -)octanoate (C8*)

 

e- decanoate (C10*)

e- dodecanoate (C12*)

e- tetra-decanoate (C14*)

e- hexa-decanoate (C16*)

e- octa-decanoate (C18*)

e- (9Z) - octadec-9-enoate (C18*)

e- (9Z, 12Z)‐octadeca‐,12‐di enoate (C18*)

Musk T*

(C13*)

 

Habanolide# (C15)

Target

 

 

 

 

 

 

 

 

Source

Source

Structure

% in product

<10

<10

35-55

15-30

5-15

<10

<10

<10

ECHA site

ECHA site

CAS#

106-32-1

110-38-3

106-33-2

124-06-1

628-97-7

111-61-5

544-35-4

111-62-6

105-95-3

34902-57-3

EC No.

945-734-0#

 

 

 

 

 

 

 

 

203-347-8

422-320-3

Registered

2018

 

 

 

 

 

 

 

 

Registered

Registered

Phys-Chem^

 

 

 

 

 

 

 

 

 

 

Vp (Pa)

0.12 meas)#

 31.4

(est.)

 

 5.70

(est.)

 1.17

(est.)

 0.34

(est.)

0.036

(est.)

 0.0084

(est.)

 0.0081

(est.)

 0.0067

(est.)

0.04

0.076

WS (mg/L)

1.6 (meas)#

 45.6

(est.)

 4.8

(est.)

 0.41

(est.)

 0.037

(est.)

 0.0037

(est.)

 0.0004

(est.)

 0.0006

(est.)

 0.0009

(est.)

30

0.954

Log Kow

4.6 (meas)#

 3.8

(est.)

 4.8

(est.)

 5.8

(est.)

 6.8

(est.)

 7.7

(est.)

 8.4

(est.)

 8.5

(est.)

 8.3

(est.)

4.7

5.45

Human health

 

 

 

 

 

 

 

 

 

 

Skin irritation

Not a skin irrit (RA)

Not a skin irrit (RA)

Not a skin irrit (RA)

Not a skin irrit (RA)

Not a skin irrit (RA)

Not a skin irrit (RA)

Not a skin irrit (RA)

Not a skin irrit (RA)

Not irrit
(OECD TG 404)

 

Eye irritation

Not an eye irrit (RA)

Not an eye irrit (RA)

Not an eye irrit (RA)

Not an eye irrit (RA)

Not an eye irrit (RA)

Not an eye irrit (RA)

Not an eye irrit (RA)

Not an eye irrit (RA)

 

Not irrit

(OECD TG 405

*The C’s are related to the chain length not the overall number of Cs (as would be presented in the Empirical formula); (est.) = estimated using EpiSuite; (exp.) = experimental;#In this column the values are for Oenanthic ether as such.

 

E- = ethyl; *Number of carbons in the chain; ^EpisSuite predicted values; *Musk T:1,4-dioxacycloheptadecane-5,17-dione;#Habanolide:A mixture of: €-oxacyclohexadec-12-en-2-one; €-oxacyclohexadec-13-en-2-one; a) (Z)-oxacyclohexadec-(12)-en-2-one and b) (Z)-oxacyclohexadec-(13)-en-2-one

 

Justification for classification or non-classification

Based on the results, the substance does not need to be classified for skin irritation or eye irritation according to EU CLP (EC No. 1272/2008 and its amendments).