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EC number: 248-227-6 | CAS number: 27107-89-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
SKIN
Hagermann (1992) (% composition of substance in test material: 70:30), K1
Under the experimental conditions employed TK 10315/S induced erythema and oedema reactions when applied to the clipped albino rabbit skin.
The reactions were reversible until the reading 10 days after application.
EYES
- In vitro
Prinsen (2009) (% composition of substance in test material: 97.9%), K1
The negative control eye showed no corneal effects. The positive control caused moderate swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 149. Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) caused very slight swelling, very slight opacity and very slight fluorescein retention. The calculated Irritation Index was 22.
On the basis of the results obtained in the ICE test and according to its classification schemes, Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was considered not irritating to eyes.
- In vivo
Prinsen (2010) (% composition of substance in test material: 97.9%), K1
At 1, 24, 48 and 72 hr after treatment, no signs of irritation were observed in the rabbits.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1st September 1992 - 11th September 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted on less pure form of the substance, namely a mixture of MOTE and DOTE with the ratio of MOTE:DOTE being 70:30.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: NDA
- Weight at study initiation: 2350 - 2670 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 1st September 1992 To: 11th September 1992 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control patch on left side of the animal.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): N/A
VEHICLE
- N/A - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 10 days.
Skin observations recorded at 1, 24, 48 and 72 hours according to the OECD scoring system. - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 12 - 16 cm²
- % coverage: NDA
- Type of wrap if used: gauze patch covered with aluminium foil
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed
- Time after start of exposure: N/A
SCORING SYSTEM: OECD 404 scoring system - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Because reactions were observed within 7 days after removing the bandages, the observation period was extended to 10 days to determine the reversibility of the skin reactions. Scaling was observed in all animals on day 7.
The skin reactions observed were reversible until the end of the observation period on day 10. - Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions employed TK 10315/S induced erythema and oedema reactions when applied to the clipped albino rabbit skin.
The reactions were reversible by the reading 10 days after application. - Executive summary:
TK 10315/S (Mono-n-octyl-tin-tris-(2-ethylhexylmercaptoacetate)) was applied to the skin female New Zealand White rabbits via an occlusive patch. The test was conducted according to OECD 404 and performed to GLP. The patch was applied for 4 hours and the rabbits were then observed for 10 days.
Under the experimental conditions employed TK 10315/S induced erythema and edema reactions when applied to the clipped albino rabbit skin.
The reactions were reversible by the reading 10 days after application.
- 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
Referenceopen allclose all
Table 1. Individual skin reaction scores.
Erythema | Edema | |||||
Animal number | 738/F CF/TF | 856/F CF/TF | 720/F CT/TF | 738/F CF/TF | 856/F CF/TF | 720/F CT/TF |
After 1 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/2 |
After 24 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/1 |
After 48 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/1 |
After 72 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/1 |
Mean 24-72 hours | 0/2 | 0/2 | 0/2 | 0/1 | 0/1 | 0/1 |
After 7 days | 0/1s | 0/1s | 0/1s | 0/0 | 0/0 | 0/0 |
After 10 days | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 | 0/0 |
CF: Control flank
TF: Test flank
s: Scaling
Table 2. Individual bodyweights.
Animal number | 738/F | 856/F | 720/F |
At start of test | 2350 | 2670 | 2560 |
After 3 days | 2360 | 2780 | 2500 |
After 7 days | 2470 | 2900 | 2700 |
After 10 days (end) | 2580 | 2990 | 2750 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27th November - December 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- chicken
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Heads of the animals were obtained from poultry slaughterhouse v.d. Bor, Amersfoortseweg 118, Nijkerkerveen, the Netherlands.
- Age at study initiation: in vitro study, eyes from 7 week old chicks were used.
- Weight at study initiation: 1.5 - 2.5 kg
ENVIRONMENTAL CONDITIONS
not applicable. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 µL
- Concentration (if solution): N/A
VEHICLE
not applicable. - Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- Approximately 30 minutes after treatment observations were recorded
- Number of animals or in vitro replicates:
- in vitro study:
1 negative control eye.
3 positive control eyes
3 test eyes - Details on study design:
- EXPERIMENTAL DESIGN
Within 2 hours after kill, eyes were carefully dissected and placed in a superfusion apparatus (see Figure 1) using the following procedure: First the eye lids were carefully removed without damaging the cornea and a small drop of Fluorescein sodium BP 2.0% w/v (Minims, Smith & Nephew Ltd., Romford, England) was applied to the corneal surface for a few seconds and subsequently rinsed off with isotonic saline at ambient temperature. Next, the head with the fluorescein treated cornea were examined with a slit lamp microscope (Slit lamp 900 BP, Haag Streit AG, Liebefeld Bern, Switzerland) to ensure that the cornea is not damaged. If undamaged, the eye was further dissected from the head without damaging the eye or cornea. Care was taken to remove the eye ball from the orbit without cutting off the optical nerve too short.
The enucleated eye was placed in a stainless steel clamp with the cornea positioned vertically and transferred to a chamber of the superfusion apparatus (TNO, Zeist, the Netherlands). The clamp holding the eye was positioned in such a way that the entire cornea was supplied with isotonic saline from a bent, stainless steel tube, at a rate of ca 0.10 0.15 mL/min (peristaltic pump set at 5.00, Watson-Marlow 205CA, Rotterdam, the Netherlands). The chambers of the superfusion apparatus as well as the saline were temperature controlled at approximately 32ºC (water pump set at 34ºC; Lauda 103, Germany).
After placing in the superfusion apparatus, the eyes were examined again with the slit lamp microscope to ensure that they are not damaged. Corneal thickness was measured using the Depth Measuring Attachment No. I for the Haag Streit slit lamp microscope. Corneal thickness was expressed in instrument units. An accurate measurement was taken at the corneal apex of each eye.
Eyes with a corneal thickness deviating more than 10% of the average corneal thickness of the eyes, eyes that show opacity (score higher than 0.5), or are unacceptably stained with fluorescein (score higher than 0.5) indicating the cornea to be permeable, or eyes that show any other signs of damage, were rejected as test eyes and replaced.
In accordance with the proposed OECD guideline no. 438, three test eyes, one negative control eye and three positive control eyes were selected for testing. Each eye provided its own baseline values for corneal swelling, corneal opacity and fluorescein retention. For that purpose, after an equilibration period of 45 60 minutes, the corneal thickness of the eyes was measured again to determine the zero reference value for corneal swelling calculations.
At time t = 0 (i.e. immediately after the zero reference measurement), the following procedure was applied for each test eye: The clamp holding the test eye was placed on paper tissues outside the chamber with the cornea facing upwards. Next, the eyes (corneas) were treated with the study substances 30µl for 10 seconds, followed by rinsing in 20ml saline.After rinsing, each eye in the holder was returned to its chamber.
The eyes were examined at ca 0, 30, 75, 120, 180 and 240 minutes after treatment, using the criteria and scoring system given in Annex 1. Fluorescein retention was only scored at ca 30 minutes after treatment. All examinations were carried out with the slit lamp microscope.
After the final examination the test substance treated eyes and the negative and positive control eyes were preserved in a neutral aqueous phosphate buffered 4% solution of formaldehyde. The corneas were embedded in paraffin wax, sectioned at 5 µM and stained with PAS (Periodic Acid-Schiff). The microscopic slides were filed in the archives and kept available for histopathological examination if considered relevant. In the case of Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE), histopathological examination was considered not relevant, because no significant corneal effects were observed.
CONTROLS
- Positive control: 5% (w/w) aqueous dilution of benzalkonium chloride
- Negative control: Saline.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with 20 mL of saline solution
- Time after start of exposure: 10 seconds
SCORING SYSTEM:
In the ICE test, the eyes were examined at several time intervals after treatment to determine ocular effects using the parameters of corneal thickness (swelling), corneal opacity and fluorescein retention. Defined scoring scales were used for each parameter to define the severity of effects into four categories (I-IV). Four classes of eye irritancy (not irritating; slightly irritating; moderately irritating; severely irritating) were identified in the ICE test by combination of the categories defined for each of the evaluation parameters using the Prediction Model described in the box below.
Regulatory classification of eye irritants was based on the standard in vivo Draize Eye test. Various international regulatory classification systems are in use. Some systems recognize four classes, viz. non irritant, mild irritant (Category 2B), irritant (Category 2A), and severe irritant (Category 1) such as in the Globally Harmonized System (UN/GHS). The new EC Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) entered into force on the 20 January 2009. CLP implements the Globally harmonised System (GHS). The EC/GHS-classification system (CLP) recognizes three classes, i.e. non-classified/non-irritant (NC/NI), irritant (Category 2) and severe irritant (Category 1).
Table 1 below shows the criteria used in the EC/GHS-regulatory classification system to identify the different classes of eye irritants
In order to translate the eye irritancy scores from the ICE test to an EC/GHS-regulatory classification, it was necessary to reconcile four irritancy classes from the ICE study into three classes within the EC/GHS-regulatory classification scheme. This was achieved through application of the prediction model defined below, which was based on scientific judgement and which was supported by several years of experience with conduct of the ICE test in parallel to the in vivo OECD 405 test. As a result of the reconciliation of the four ICE classes of irritancy into the 3 classes of the EC/GHS-regulatory classification system, it is possible that materials defined as slightly irritant using the ICE test Prediction Model may be identified in the EC-regulatory classification system as not classified/non-irritant.
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test material
- Value:
- 22
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- no effects
- Positive controls validity:
- valid
- Remarks:
- Irritation Index = 149
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The negative control eye showed no corneal effects. The positive control caused moderate swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 149. Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) caused very slight swelling, very slight opacity and very slight fluorescein retention. The calculated Irritation Index was 22.
On the basis of the results obtained in the ICE test and according to its classification schemes, Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was considered not irritating to eyes. - Executive summary:
Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was evaluated neat in the Isolated Chicken Eye (ICE) test, according to OECD guideline no. 438. Chicken eyes were obtained from slaughter animals used for human consumption. The isolated chicken eyes were exposed to a single application of the test sample for 10 seconds using an application volume of 30 µL. Benzalkonium chloride (BAC) 5% was used as the positive control and physiological saline as the negative control. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells.
The negative control eye showed no corneal effects. The positive control caused moderate swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 149. Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) caused very slight swelling, very slight opacity and very slight fluorescein retention. The calculated Irritation Index was 22.
On the basis of the results obtained in the ICE test and according to its classification schemes, Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was considered not irritating to eyes.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26th January 2010 - 29th January 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline 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
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: young
- Weight at study initiation: 2148, 1958 and 2179 g
- Housing: individually in cages, fitted with a perforated floor (Rack Multifloor pen system, 785x840x450 mm) with cage enrichment.
- Diet (e.g. ad libitum): Standard laboratory diet ad libitum.
- Water (e.g. ad libitum): Tap water (N.V. Vitens) ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 ºC
- Humidity (%): 45 - 70 %
- Air changes (per hr): 10 air changes/hour
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 20th January 2010 To: 29th January 2010 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated left eye served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): N/A
VEHICLE
N/A - Duration of treatment / exposure:
- Single dose. Eyes held shut for at least 1 second.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure: N/A
SCORING SYSTEM: See any other information section.
TOOL USED TO ASSESS SCORE: NDA - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- At 1, 24, 48 and 72 hr after treatment, no signs of irritation were observed in the rabbits.
- Other effects:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- At 1, 24, 48 and 72 hr after treatment, no signs of irritation were observed in the rabbits.
- Executive summary:
The eyes of 3 young New Zealand White rabbits were assessed for irritation by application of Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) according to OECD 405. The study was conducted to GLP standard.
At 1, 24, 48 and 72 hr after treatment, no signs of irritation were observed in the rabbits.
Referenceopen allclose all
Table 2: Summary of Results
Test material |
Maximum mean score for: |
Irritation categories1 |
Irritation Index2 |
Classification (General, GHS and EC/GHS) |
||
Swelling % |
Opacity |
Fluorescein retention |
||||
MOTE |
2 |
0.5 |
0.5 |
I;I;I |
22 |
NI/NI/NI |
BAC 5% |
295 |
3.0 |
3.0 |
III;IV;IV |
149 |
severe/I/I |
Saline (negative control)6 |
0 |
0.0 |
0.0 |
n.a.7 |
n.a. |
n.a. |
1 I = no effect; II = slight effect; III = moderate effect; IV = severe effect.
2 Irritation Index = maximum mean corneal swelling + maximum mean opacity (x 20) + mean fluorescein score (x 20).
3 2B = mild irritant; 2A = irritant; 1 = serious eye damage. United Nations-Economic Commission for(UN/ECE) (2003). Globally Harmonised System of Classification and Labelling of Chemicals (GHS). UN,and, 2007 (http://www.unece.org/trans/danger/publi/ghs/ghs_rev02/02files_e.html)
4 Blistering of epithelium.
5 Individual values based on one eye.
6 n.a. = not applicable
EC/GHS‑CLASSIFICATION (CLP) OF EYE IRRITANTS; EXTRAPOLATION FROM IN VITRO RESULTS TO IN VIVO CLASSIFICATION.
Extrapolation from thein vitroirritancy results to the EC/GHS classification will be carried out using scientific judgement, re-dividing the original four irritancy classes to three. The combinations of the three categories that are allowed for each of the three classifications are mentioned in the scheme below.
NC/NI = not classified/not irritating 3 x I
2 x I, 1 x II
2 x II, 1 x I3
EC/GHS Category 24: 3 x II
Irritating to eyes 2 x II, 1 x III
1 x I, 1 x II, 1 x III¹
3 x III
2 x III, 1 x II
2 x III, 1 x I
2 x I, 1 x IV¹
2 x II, 1 x IV¹
2 x III, 1 x IV2
1 x II, 1 x III, 1 x IV¹
EC/GHS Category 14: 3 x IV
Irreversible effects on the eye/ 2 x IV, 1 x III
serious damage to eyes 2 x IV, 1 x II¹
2 x IV, 1 x I¹
immediate corneal opacity score 3
corneal opacity score 4
severe loosening of epithelium
¹ Combinations of categories less likely to occur.
2The combination of 2 x III, and 1 x IV can be considered as a borderline case between irritating and severely irritating.
3The combination of 2 x II, and 1 x I can be considered as a borderline case between not irritating and Category 2.
4Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Table 1. Individual scores.
Time after exposure | Animal number | Corneal effects | Iris | Conjuctivae | Discharge | ||
Score | Area | Redness | Swelling | ||||
1 | 2 | 0 | 4 | 0 | 0 | 0 | 0 |
4 | 0 | 4 | 0 | 0 | 0 | 0 | |
6 | 0 | 4 | 0 | 0 | 0 | 0 | |
24 | 2 | 0 | 4 | 0 | 0 | 0 | 0 |
4 | 0 | 4 | 0 | 0 | 0 | 0 | |
6 | 0 | 4 | 0 | 0 | 0 | 0 | |
48 | 2 | 0 | 4 | 0 | 0 | 0 | 0 |
4 | 0 | 4 | 0 | 0 | 0 | 0 | |
6 | 0 | 4 | 0 | 0 | 0 | 0 | |
72 | 2 | 0 | 4 | 0 | 0 | 0 | 0 |
4 | 0 | 4 | 0 | 0 | 0 | 0 | |
6 | 0 | 4 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
SKIN
Hagermann (1992) (% composition of substance in test material: 70:30), K1
The Hagemann, in vivo skin irritation study was performed according to the OECD guideline for testing No. 404, and was conducted under conditions of Good laboratory practice. Under the conditions of the test 0.5 mL of the test material was applied unchanged to a gauze patch (12 x 16 cm2) and applied to the shaved, right flank of 3 female albino rabbits. The patches were removed after 4 hours and the animals were observed for skin reactions at 1, 24, 48 and 72 hours after removal of the gauze patches. The scoring system used was that shown in the OECD guideline. Erythema was noted in all animals and was scored at 2 for each animal (mean of 24 -48 -72 hours). Erythema persisted in all animals at the 2 level for 72 hours, and then at a level of 1 (with scaling also noted) for 7 days post removal of the patch, because of this the observation period was extended to 10 days at the end of which all irritation was reversed. Oedema was noted in all animals and was scored at 1 for each animal (mean of 24 -48 -72 hours), these effects were fully reversible in 72 hours.
EYES
- In vitro
Prinsen (2009) (% composition of substance in test material: 97.9%), K1
Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was evaluated neat in the Isolated Chicken Eye (ICE) test, according to OECD guideline no. 438. Chicken eyes were obtained from slaughter animals used for human consumption. The isolated chicken eyes were exposed to a single application of the test sample for 10 seconds using an application volume of 30 µL. Benzalkonium chloride (BAC) 5% was used as the positive control and physiological saline as the negative control. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells.
The negative control eye showed no corneal effects. The positive control caused moderate swelling, severe opacity and severe fluorescein retention. The calculated Irritation Index was 149. Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) caused very slight swelling, very slight opacity and very slight fluorescein retention. The calculated Irritation Index was 22.
On the basis of the results obtained in the ICE test and according to its classification schemes, Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) was considered not irritating to eyes.
- In vivo
Prinsen (2010) (% composition of substance in test material: 97.9%), K1
The Prinsen, 2010 in vivo eye irritation study was conducted according to OECD guideline 405 and under conditions of Good Laboratory Practice. 0.1ml of the unchanged registered substance was instilled in the conjunctival sac of the right eye of 3 SPF bred New Zealand White albino rabbits. Observations were made at 1, 24, 48 and 72 hours after treatment. No irritation was noted at any of the observation periods.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to skin or eye irritation.
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