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EC number: 821-762-8 | CAS number: 4563-56-8
- 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
- Nanomaterial porosity
- 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 irritation (rabbit): not irritant
RA from CAS 4259-15-8
Eye irritation (rabbit): serious eye damage
RA from CAS 4259-15-8
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-15 weeks
- Housing: Housed individually in wire-bottom cages
- Diet: rationed
- Water: ad libitum
- Acclimation period: 15-36 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-22.2
- Humidity (%): 31-74
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Number of animals:
- 12
- Details on study design:
- TEST SITE
- Type of wrap if used: gauze wrapped in plastic sheet
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with gauze pads moistened with mineral oil followed by a dry gauze pad
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992
- 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
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: LSR Industries Inc.
- Housing: singly in wire mesh suspension cages
- Diet: ad libitum
- Water: ad libitum.
- Acclimation period: at least 1 day
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: 01 June 1992 – 18 June 1992 - Vehicle:
- other: mineral oil
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
- Observation period (in vivo):
- The eyes were examined and graded for ocular reaction at 24, 48, and 72 hours following instillation of test material into the eyes
- Number of animals or in vitro replicates:
- 12 rabbits (three males and three females per group)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: not applicable
SCORING SYSTEM: Interpretation of the results was made in accordance with the Draize technique for scoring ocular lesions. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- by day 3 in 2/6 animals
- Remarks on result:
- other: concentration as supplied
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- by day 3 in 4/6 animals
- Remarks on result:
- other: concentration as supplied
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- in 4/6 animals
- Remarks on result:
- other: concentration as supplied
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- by day 3 in 6/6 animals
- Remarks on result:
- other: concentration as supplied
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 50% in mineral oil
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: 50% in mineral oil
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: 50% in mineral oil
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- by day 3 in 1/6 animals
- Remarks on result:
- other: 50% in mineral oil
- Interpretation of results:
- other: Eye Dam. 1, H318 according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: Eye Dam. 1, H318
- Executive summary:
In a primary eye irritation study, 0.1 mL of undiluted test substance or 50% in mineral oil was placed into one eye of each of the New Zealand White rabbits. The test substance produced serious eye damage up to 72 hours when tested as supplied and was not an ocular irritant when tested as a 50% formulation in mineral oil.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- 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
- Weight at study initiation: 2.38 to 2.64 kg
- Housing: Housed individually in wire mesh suspension cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-26.1
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Number of animals or in vitro replicates:
- 9 (6 rinsed, 3 unrinsed)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): for 3 animals rinsed for one minute 200 mL of lukewarm tap water
- Time after start of exposure: 30 seconds
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.17
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Non-rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.55
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- other: Rinsed
- Irritant / corrosive response data:
- According to the study conducted, the test substance causes persistent eye irritation through 21 days. Rinsing the test material out of the eyes 30 seconds after the exposure resulted in eye irritation that was reversible within 21 days.
- Interpretation of results:
- other: Eye Dam. 1, H318 according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: Eye Dam. 1, H318
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- (non-GLP, no individual scores given, 14 days of observation instead of 21 days)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.25 - 2.75 kg
- Housing: Housed individually in wire bottom cages
- Diet: 4 ounces daily
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM:
Modification of Draize:
Cornea:
1 = Slight opacity
2 = moderate opacity
3 = dense opacity
4 = complete opacity
Iris:
1 = mild iritis
2 = severe iritis
Conjuctivae (redness and discharge):
1 = slight
2 = moderate
3 = severe
Conjuctivae (chemosis):
1 = slight
2= moderate
3 = severe
4 = extreme
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 31
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Interpretation of results:
- other: Eye Dam. 1, H318 according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: Eye Dam. 1, H318
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- (non-GLP, individual scores were not given)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16CFR 1500.42- Federal Hazardous Substances Act Regulations
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: stainless steel with elevated wire mesh flooring, 1 rabbit/cage
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.6-23.8
- Humidity (%): 40-50
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 21 March 1983 – 11 April 1983 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
- Observation period (in vivo):
- The eyes were examined and graded for ocular reaction at 1, 2, 3, 4, 7, 14 and 21 days following instillation of test material into the eyes.
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing.
SCORING SYSTEM: Interpretation of the results was made in accordance with the Draize technique for scoring ocular lesions. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 21
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 14
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- in 1/6 animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- in 4/6 animals
- Interpretation of results:
- other: Eye Dam. 1, H318 according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: Eye Dam. 1, H318
- Executive summary:
In a primary eye irritation study, 0.1 mL of undiluted test substance was placed into one eye of each of the New Zealand White rabbits. The test substance produced ocular irritation that did not resolve by 21 day.
The test substance is classified as Category 1 in accordance with the classification system of GHS.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for read-across
There are no reliable data available on irritation / corrosion forPhosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic(CAS 4563-56-8). Read-across from an appropriate substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259-15-8) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.1 and 8.2. Common functional groups, structural similarities and comparable toxicological properties of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Skin irritation / corrosion
The skin irritancy potential of Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259-15-8) was investigated in NZW rabbits similar to OECD Guideline 404 and GLP (Key, 1986). In this study, 0.5 mL of the undiluted test substance was applied to the dorsal back of NWZ rabbits for 4 h under semi-occlusive conditions. After 4 h, the test substance was removed using a gauze pad moistened with mineral oil followed by a dry gauze pad. The mean erythema score of all animals (24/48/72 h) was 1.0 and the mean edema score (24/48/72 h) was 0.22. The individual scores were not given. Based on the results of this study, the test substance is not considered to have an irritancy potential towards the skin.
In a further study 6 NZW rabbits were treated with 0.5 mL Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259-15-8) under semi-occlusive conditions (Supporting, 1987, RL1) similar to OECD 404 and GLP for 4 h. The intent of the experiment was to compare two methods of test material removal. Each animal had two test sites. The test material was removed with a dry gauze pad from one site and from a gauze pad moistened with mineral followed by a dry gauze pad on the other site. Based on the results of the conducted study, the test substance showed an irritancy potential when the test material was removed with a dry gauze wipe (edema score of 2; erythema score of 3.5), but no irritancy potential when removed with mineral oil wipe (edema score of 0.4; erythema score of 1.4).
Repeated application of 10% Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259-15-8) in mineral oil to the skin of rabbits results in accumulating and increasing irritation (Supporting, 1987, RL2). However, this procedure is not according to the current OECD guideline 404, therefore the study was not used for classification.
Eye irritation
Four equal reliable eye irritation studies were available with Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259-15-8).
In the study performed according to OECD 405 and GLP 0.1 mL of the undiluted test substance and 0.1 mL of the 50% test substance in mineral oil was instilled into the eye of each of 6 rabbits without washing, respectively (WoE, 1992). The respective untreated eye served as control. The eyes were examined and graded for ocular reaction at 24, 48, and 72 h days following instillation of test material into the eyes. The 50% dilution of the test material resulted in a mean cornea opacity score and a mean iris score of 0 (24/48/72 h). The mean score (24/48/72 h) for conjunctivae and for chemosis was 0.4. Conjunctivae was fully reversible within 72 h, chemosis was not reversible by day 3 in 1/6 animals. The undiluted test material resulted in a mean cornea opacity score (24/48/72 h) of 0.5 which was not reversible by day 3 in 2/6 rabbits and in a mean iris score (24/48/72 h) of 0.6 which was not reversible by day 3 in 4/6 animals. The mean scores (24/48/72 h) for conjunctivae and chemosis were 1.6 and 1.8, respectively. Both effects were not reversible in 4/6 rabbits and in 6/6 rabbits, respectively. The individual scores were not given.
Based on the results of the conducted study, the undiluted test material caused serious eye damage while the 50% formulation in mineral oil showed no irritant potential towards the eyes.
In the second study performed according to OECD 405 and GLP 0.1 mL of the undiluted test substance was instilled into the eye of 9 NZW rabbits (WoE, 1996). For 3 animals, the eyes were rinsed after a treatment period of 30 s for one minute with 200 mL of lukewarm tap water. The eyes of 6 rabbits were not washed. The respective untreated eye served as control. The undiluted test material without washing resulted in a mean cornea opacity score (24/48/72 h) of 1.17 which was not reversible and in a mean iris score (24/48/72 h) of 0.6 which was fully reversible within 14 days. The mean scores (24/48/72 h) for conjunctivae and chemosis were 2.17 and 2.67, respectively. Both effects were not reversible. The experimental approach with washing revealed a mean cornea score (24/48/72 h) of 0.33, a mean iris score (24/48/72 h) of 0.0, a mean conjunctivae score (24/48/72 h) of 1.55 and a mean chemosis score (24/48/72 h) of 1.44. These effects were fully reversible. The individual scores were not given.
Based on the results of the conducted study, the undiluted test material causes serious eye damage. Rinsing the test material out of the eyes 30 seconds after the exposure resulted in eye irritation that was reversible within 21 days.
In the third study, 0.1 mL of the undiluted test material without washing was investigated similar to OECD 405 in NZW rabbits (WoE, 1975). After instillation of the test material the animals were observed for 14 days. The mean cornea opacity score (24 - 72 h) was 1.1 which was not reversible within 14 days. The mean iris score (24 - 72 h) was 0.8 and was reversible within 10 days. The mean conjunctivae score (24 - 72 h) of 1.55 and the mean chemosis score (24 - 72 h) were 3.0 and 1.7, respectively. Both effects were not reversible within 14 days. Based on the results of the conducted study, the test substance was considered to cause serious eye damage.
In a study conducted similar to 16CFR 1500.42- Federal Hazardous Substances Act Regulations, 0.1 mL of undiluted Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259-15-8) was instilled into one eye each of NZW rabbits while the other eye remained untreated to serve as a control (WoE, 1983). The test material was not washed from the eyes. The eyes were examined and graded for ocular reaction at 1, 2, 3, 4, 7, 14 and 21 days following instillation of test material into the eyes. A mean cornea opacity score (24/48/72 h) of 0.3 was determined, which was not reversible by day 21 and a mean iris score (24/48/72 h) of 0.6 was determined, which was not reversible by day 14. The mean scores (24/48/72 h) for conjunctivae and chemosis were 1.6 and 3.5 and not reversible in 1/6 and 4/6 animals, respectively.
In conclusion, based on the results with the source substance, the target substance is not considered to have an irritancy potential towards the skin, but is considered to cause serious eye damage.
Justification for classification or non-classification
Applying the RA-approach, the available data on skin irritation / corrosion do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.
Applying the RA-approach, the available data on eye irritation meet the classification criteria, Eye Dam. 1, H318 according to Regulation (EC) 1272/2008.
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