Registration Dossier

Administrative data

Description of key information

Skin irritation:
- In vitro Human Skin Model Test (OECD 431, GLP): not irritating
- In vitro Reconstructed Human Epidermis (RhE) Test Method (OECD draft, GLP): not irritating
Eye irritation:
- In vitro Bovine Corneal Opacity and Permeability (BCOP) test (OECD 437, GLP): not irritating
- In vivo acute eye irritation/corrosion test (OECD 405, GLP): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles. A reliability of 2 is assigned in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID, due to the read-across purpose.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
OECD Draft Proposal for a New Guideline: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
other: human-derived epidermal keratinocytes. (highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum)
Cell source:
other: not specified
Source strain:
not specified
Details on animal used as source of test system:
SOURCE ANIMAL
- Source: adult human-derived epidermal keratinocytes
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Standard ModelTM (EPISKIN-SMTM, 0.38 cm2) This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
- Tissue batch number: Lot no.: 10-EKIN-006

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Washing with phosphate buffered saline 15 minutes after exposure.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.

PREDICTION MODEL / DECISION CRITERIA
If the mean relative tissue viability was above 50% after 15 minutes treatment the substance is considered to be non-irritant.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µl

NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 10 µl Phosphate buffered saline

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 10 µl
- Concentration (if solution): 5% (aq) Sodium dodecyl sulphate
Duration of treatment / exposure:
Exposure: 15 minutes
Duration of post-treatment incubation (if applicable):
Post incubation period: 42 hours
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
15 minutes
Value:
123
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
viability: percentage of control. Time point: 15 minutes.
Other effects / acceptance of results:
The positive control had a mean cell viability after 15 minutes exposure of 22%. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.

Interpretation of results:
other: Not irritating
Remarks:
Based on CLP criteria
Conclusions:
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Standolized linseed oil compared to the negative control tissues was 123%. Since the mean relative tissue viability for Standolized linseed oil was above 50% after 15 minutes treatment Standolized linseed oil is considered to be non-irritant.

The positive control had a mean cell viability after 15 minutes exposure of 22%. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.

Finally, it is concluded that this test is valid and that Standolized linseed oil is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles. A reliability of 2 is assigned in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID, due to the read-across purpose.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
OECD Guidelines for Testing of Chemicals, Guideline no. 431: In Vitro Skin Corrosion: Human Skin Model Test (adopted 13 April 2004).
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Cell type:
other: human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
Cell source:
other: not specified
Source strain:
not specified
Details on animal used as source of test system:
SOURCE ANIMAL
- Source: human-derived epidermal keratinocytes
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model (EPI-200) The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized 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. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.
- Tissue batch number: 12907 kit JJ

REMOVAL OF TEST MATERIAL AND CONTROLS
Washing with phosphate buffered saline.
- Time after start of exposure: 3 minutes and 1 hour

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be non-corrosive to skin if complete, e.g. the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl

NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 50 µl Milli-Q water

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µl KOH
- Concentration (if solution): 8N
Duration of treatment / exposure:
3 minutes and 1 hour exposure times
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
after 3 minutes
Value:
96
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
after 15 minutes
Value:
96
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The positive control had a mean relative tissue viability of 16% after 3 minutes exposure. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter-tissue variability in viability between two tissues treated identically was less than 14% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 7%, indicating that the test system functioned properly.

Interpretation of results:
other: Not irritating
Remarks:
Based on CLP criteria
Conclusions:
The positive control had a mean relative tissue viability of 16% after 3 minutes exposure. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter-tissue variability in viability between two tissues treated identically was less than 14% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 7%, indicating that the test system functioned properly.

Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with Standolized linseed oil compared to the negative control tissues was 96%. Because the mean relative tissue viability for Standolized linseed oil was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Standolized linseed oil is considered to be not corrosive.

Finally, it is concluded that this test is valid and that Standolized linseed oil is not corrosive in the in vitro skin corrosion test under the experimental conditions described in this report.
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See attached justification
Reason / purpose for cross-reference:
read-across source
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
15 minutes
Value:
123
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
viability: percentage of control. Time point: 15 minutes.
Other effects / acceptance of results:
The positive control had a mean cell viability after 15 minutes exposure of 22%. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.

Interpretation of results:
other: Not irritating
Remarks:
Based on CLP criteria
Conclusions:
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Standolized linseed oil compared to the negative control tissues was 123%. Since the mean relative tissue viability for Standolized linseed oil was above 50% after 15 minutes treatment Standolized linseed oil is considered to be non-irritant.

The positive control had a mean cell viability after 15 minutes exposure of 22%. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.

Finally, it is concluded that this test is valid and that Standolized linseed oil is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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:
experimental study
Adequacy of study:
key study
Study period:
22 February 2010 - 04 March 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles. A reliability of 2 is assigned in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID, due to the read-across purpose.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Belton, Leics, England
- Age at study initiation: Animals used within the study were at least 6 weeks old
- Weight at study initiation: body weights were at least 1.0 kg.
- Housing: labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.5 - 19.2º
Temporary deviations from the minimum level of temperature occurred.
Evaluation: Laboratory historical data do not indicate an effect of the deviations.
- Humidity (%): 51 - 87%
Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day

IN LIFE DATES: From: 22 February 2010 To: 04 March 2010
Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 mL
Duration of treatment / exposure:
Single instillation on Day 1
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
Number of animals or in vitro replicates:
3 Males
Details on study design:
STUDY DESIGN
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner approximately one week later, after considering the degree of eye irritation observed in the first animal.

TREATMENT
Each animal was treated by instillation of 0.1 mL of the test substance in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.

Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.

After the final observation, the animals were sacrificed by intra-venous injection of Euthasol® 20% (AST Farma BV, Oudewater, The Netherlands).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

OBSERVATION
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:

SCORING SYSTEM:
CORNEAL IRRITATION
Opacity: degree of density (area most dense taken for reading)
0: No ulceration or opacity (may include slight dulling of normal luster)
1: Scattered or diffuse areas of opacity, details of iris clearly visible
2: Easily discernible translucent area, details of iris slightly obscured
3: Nacreous area, no details of iris visible, size of pupil barely discernible
4: Opaque cornea, iris not discernible through the opacity

Area of cornea involved:
0: No ulceration or opacity
1: One quarter or less but not zero
2: Greater than one quarter, but less than half
3: Greater than half, but less than three quarters
4: Greater than three quarters, up to whole area

IRIS
0: Normal
1: Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia,
or injection, any of these or combination thereof, iris still reacting to light
(sluggish reaction is positive)
2: No reaction to light, hemorrhage, gross destruction (any or all of these)

CONJUNCTIVAL IRRITATION
Redness (refers to palpebrae and sclera, excluding cornea and iris):
0: Blood vessels normal
1: Some blood vessels definitely hyperaemic (injected)
2: Diffuse, crimson color, individual vessels not easily discernible
3: Diffuse beefy red

Chemosis (refers to lids and/or nictitating membranes):
0: No swelling
1: Any swelling above normal (includes nictitating membranes)
2: Obvious swelling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids more than half closed

Discharge:
0: No discharge (may include small amounts observed in inner canthus of normal animals)
1: Any amount different from normal and/or lacrimation
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs (considerable area around the eye)

Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp.
In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission, Washington, D.C. 20207 was used for additional control purposes.

Irritation parameter:
cornea opacity score
Remarks:
Opacity.
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects noted
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects noted
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: No effects noted.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours for all animals
Remarks on result:
other: All animals scored 1 at 1 hours observation.
Irritant / corrosive response data:
Instillation of 0.1 mL of Standolized linseed oil into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness and discharge. The irritation completely resolved within 24 hours in all animals.

No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.

See also attached tables.
Other effects:
Coloration / Remnants:
No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.

Toxicity / Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
other: Not irritating
Remarks:
Based on CLP criteria
Conclusions:
Based on these results Standolized linseed oil does not have to be classified and has no obligatory labeling requirement for eye irritation according to the:
-Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007),
-Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02-February-2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles. A reliability of 2 is assigned in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID, due to the read-across purpose.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
SOURCE OF COLLECTED EYES
- Source: Bovine eyes from young cattle were obtained from the slaughterhouse, where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
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

Duration of post- treatment incubation (in vitro):
- Post incubation period: 120 minutes
Details on study design:
NEGATIVE CONTROL USED
Yes, physiological saline

POSITIVE CONTROL USED
Yes, 10% (w/v) Benzalkonium Chloride

APPLICATION DOSE AND EXPOSURE TIME
10 minutes

POST-INCUBATION PERIOD: yes
120 minutes

REMOVAL OF TEST SUBSTANCE
- 10 minutes after exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.

METHODS FOR MEASURED ENDPOINTS:
- 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).
- opacitymeter and microplate reader were used.

SCORING SYSTEM: In Vitro Irritancy Score (IVIS)

DECISION CRITERIA: A test substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant
Irritation parameter:
in vitro irritation score
Remarks:
(IVIS)
Run / experiment:
mean after 10 minutes exposure
Value:
1.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The positive and negative controls were within the historical control data.
Interpretation of results:
other: Not irritating
Remarks:
Based on CLP criteria
Conclusions:
The positive and negative controls were within the historical control data.

Standolized linseed oil did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.5 after 10 minutes of treatment.

Finally, it is concluded that this test is valid and that Standolized linseed oil is a non irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See attached justification
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
in vitro irritation score
Remarks:
(IVIS)
Run / experiment:
mean after 10 minutes exposure
Value:
1.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The positive and negative controls were within the historical control data.
Interpretation of results:
other: Not irritating
Remarks:
Based on CLP criteria
Conclusions:
The positive and negative controls were within the historical control data.

Standolized linseed oil did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.5 after 10 minutes of treatment.

Finally, it is concluded that this test is valid and that Standolized linseed oil is a non irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See attaeched justification
Reason / purpose for cross-reference:
read-across source
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Irritation parameter:
cornea opacity score
Remarks:
Opacity.
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects noted
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects noted
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: No effects noted.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours for all animals
Remarks on result:
other: All animals scored 1 at 1 hours observation.
Irritant / corrosive response data:
Instillation of 0.1 mL of Standolized linseed oil into one eye of each of three rabbits resulted in irritation of the conjunctivae, which consisted of redness and discharge. The irritation completely resolved within 24 hours in all animals.

No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.

See also attached tables.
Other effects:
Coloration / Remnants:
No staining of (peri) ocular tissues by the test substance was observed and no test substance remnants were seen.

Toxicity / Mortality:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Interpretation of results:
other: Not irritating
Remarks:
Based on CLP criteria
Conclusions:
Based on these results Standolized linseed oil does not have to be classified and has no obligatory labeling requirement for eye irritation according to the:
-Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007),
-Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The results of Standolized Linseed Oil (SLO) can be read across to Standolized Soybean Oil (SSO) as SLO and SSO share similar structures and reactivity, based on the fatty acids composition of the raw material oils. Due to higher level of polyunsaturated fatty acid chains, SLO presents the worst case scenario in terms of toxicology. (see read across document for further details)

The in vitro key studies for the endpoint skin irritation indicate that no irritation is to be expected. Additionally, the acute dermal toxicity test indicates that no skin irritation was observed in rats up to a single dose of 2000 mg/kg bw.

For eye irritation, both an in vitro and an in vivo test were performed. In both studies, no eye irritation was observed.


Justification for selection of skin irritation / corrosion endpoint:
Two key in vitro skin irritation studies are available for this endpoint, both concluding that there is no dermal irritation to be expected. The Human Skin Model Test was selected as this is an adopted OECD guideline (the RhE test is still a draft OECD guideline).

Justification for selection of eye irritation endpoint:
This study is the in vivo study which is considered of higher toxicological relevance as compared to the in vitro study, although that study indicates the same result.

Justification for classification or non-classification

Based on the available information for skin and eye irritation, Standolized Soybean Oil does not need to be classified for these endpoints according to the criteria outlined in Annex I of CLP (1272/2008/EC) and Annex VI of DSD (67/548/EEC).