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EC number: 939-415-5 | CAS number: -
- 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
Key (EC 613 -848 -7), Sanders, 2013, Skin irritation - not irritating
Supporting (EC 234-392-1), Clouzeau, 1990, Skin irritation – not
irritating
Supporting (CAS 68424-31-7), Robinson, 1991 Skin irritation – not
irritating
Eye Irritation
Key (EC 613 -848 -7), Sanders, 2013, Eye irritation - not irritating
Supporting (EC 234-392-1), Clouzeau, 1990, Eye irritation – not
irritating
Supporting (CAS 68424-31-7), Robinson, 1991, Eye irritation – not
irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-05-21 to 2013-05-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.26-2.33 kg
- Housing: Animals were individually housed in suspended cages.
- Diet: Food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: 2013-05-21 To: 2013-05-24 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Test item was used as supplied (undiluted)
- pH of the undiluted test item: 6.0
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- Immediately following removal of the patches and approximately 1, 24, 48 and 72 h later, the sites were examined for evidence of primary irritation.
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: On the day of the test a suitable site was selected on the back of each rabbit. A quantity of 0.5 mL of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch.
- Type of wrap if used: Treatment site was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing: Four hours after application the corset and patches were removed from animals and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize method - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Very slight erythema was noted at two treated skin sites 1 and 24 h after patch removal.
No evidence of skin irritation was noted at one treated skin site during the study. - Other effects:
- All animals showed expected gain in body weight during the study.
- Interpretation of results:
- not irritating
- Conclusions:
- Under the test conditions the substance is not classified as irritating to skin according to the criteria of CLP Regulation (EC) No. 1272/2008.
- Executive summary:
Test Guidance
OECD guideline 404 and EC Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion).
Method and materials
Three New Zealand White male rabbits were dermally exposed to 0.5 mL of the test material for 4 h under a semi-occlusive dressing. After removal of the residual test item, irritation was scored immediately following removal of the patches and approximately 1, 24, 48 and 72 h later, according to Draize method.
Results
Very slight erythema was noted at two treated skin sites 1 and 24 h after patch removal. No evidence of skin irritation was noted at one treated skin site during the study. All animals showed expected gain in body weight during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.3, 0.3 for erythema and 0.0, 0.0, 0.0 for oedema score, respectively. The mean erythema and oedema scores at 24, 48 and 72 h were 0.22 and 0.0 respectively. The substance is not a skin irritant in male rabbits.
Conclusion
Under the test conditions the substance is not classified as irritating to skin according to CLP Regulation (EC) No. 1272/2008.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions Lack of details in study documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Lack of details in study documentation
- Principles of method if other than guideline:
- Application of 0.5 ml to an area of approx. 2.5 cm x 2.5 cm.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- No Data
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): No Data - Duration of treatment / exposure:
- 4 h
- Observation period:
- 12 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm² on the shorn left flank (dorso-lumbar region)
- Type of wrap if used: semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water upon the removal of the dressing
- Time after start of exposure:4 h
SCORING SYSTEM: Draize scale - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of animal #15 and readings at
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 12 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of animal #16 and readings at
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of animal #17 and readings at
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of animal #15 and readings at
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of animal #16 and readings at
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of animal #17 and readings at
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- Following the single 4-hour application, a very slight to well-defined erythema and very slight to slight oedema were observed. This regressed and no signs of erythema or oedema were evident eleven or twelve days after application. Slight desquamation at the application site of one animal was observed seven days after application.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- November 13th, 1990 - November 16th, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Lack of details on test substance
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elvage Cunicole du Val de Selle, France
- Weight at study initiation: 2.3 kg
- Diet: ad libitum; Rabbit substance ref. 112 C
- Water: ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm², flanks were clipped a day before treatment
- Type of wrap if used: adhesive hypoallergic aerated semi-occlusive dressing (Laboratories de Pansements et d´Hygiène, France)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM:According to Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no cutaneous effects observed
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no cutaneous effects observed
- Interpretation of results:
- not irritating
- Endpoint:
- skin 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: analogue substance
- Justification for type of information:
- Skin irritation in vivo does not need to be investigated because available data indicate that structural variation does not influence test results or adverse effect profile (see read-across and category justifications attached in Section 13).
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Referenceopen allclose all
Table 7.3.1/1: Individual Skin Reactions
Skin Reaction |
Observation Time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
73197 Male |
73198 Male |
73199 Male |
||
Erythema/Eschar Formation |
Immediately |
0 |
0 |
0 |
1 h |
0 |
1 |
1 |
|
24 h |
0 |
1 |
1 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.3 |
0.3 |
|
Oedema Formation |
Immediately |
0 |
0 |
0 |
1 h |
0 |
0 |
0 |
|
24 h |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
0.0 |
Individual body weights and body weight change:
Rabbit Number |
Individual body weight (kg) |
Body weight change (kg) |
|
Day 0 |
Day 3 |
||
73197 |
2.33 |
2.40 |
0.07 |
73198 |
2.27 |
2.29 |
0.02 |
73199 |
2.26 |
2.29 |
0.03 |
Erythema score
Animal Number |
1 h |
24 h |
48 h |
72 h |
7 days |
11 days |
12 days |
Mean Score |
15 |
2 |
- |
1 |
1 |
1 |
|
0 |
1.0 |
16 |
2 |
2 |
1 |
1 |
1 |
0 |
|
1.3 |
17 |
1 |
2 |
1 |
1 |
0 |
|
|
1.3 |
Edema Score
Animal Number |
1 h |
24 h |
48 h |
72 h |
7 days |
11 days |
12 days |
Mean Score |
15 |
1 |
- |
1 |
1 |
0 |
|
0 |
1.0 |
16 |
2 |
2 |
2 |
1 |
0 |
0 |
|
1.7 |
17 |
1 |
2 |
2 |
1 |
0 |
|
|
1.7 |
Conclusion: The test substance does not have to be classified as irritant to the skin according to the criteria of the DSD and CLP regulations under the conditions of this study.
Erythema score
Animal Number |
1 h |
24 h |
48 h |
72 h |
O1 |
0 |
0 |
0 |
0 |
O2 |
0 |
0 |
0 |
0 |
O3 |
0 |
0 |
0 |
0 |
Edema Score
Animal Number |
1 h |
24 h |
48 h |
72 h |
O1 |
0 |
0 |
0 |
0 |
O2 |
0 |
0 |
0 |
0 |
O3 |
0 |
0 |
0 |
0 |
No cutaneous reactions were observed in all the animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-05-28 to 2013-06-20
- 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
- Principles of method if other than guideline:
- Not applicable
- 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 Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.37-2.70 kg
- Housing: Animals were individually housed in suspended cages.
- Diet: Food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 h dark / 12 h light
IN-LIFE DATES: From: 2013-05-28 To: 2013-06-20 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Test item was used as supplied (undiluted)
- pH of undiluted test item: 6.0
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Eyes were not rinsed throughout study
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1, 24, 48 and 72 h following treatment.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: Draize method
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 h observation.
- All treated eyes appeared normal at the 48 h observation. - Other effects:
- One animal showed body weight loss, one animal showed no gain in body weight and the remaining animal showed expected gain in body weight during the study.
- Interpretation of results:
- not irritating
- Conclusions:
- Under the test conditions the substance is not classified as irritating to eyes according to the criteria of CLP Regulation (EC) No. 1272/2008.
- Executive summary:
Test Guidance
OECD guideline 405 and EC Method B.5 (Acute Toxicity: Eye Irritation / Corrosion).
Method and materials
Three New Zealand White male rabbits were exposed to 0.1 mL of test item in the right eye while the left eye remained untreated and served as control. The eyelids were then gently held together for one second before releasing. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method.
Results
No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 h observation. All treated eyes appeared normal at the 48 h observation. One animal showed body weight loss, one animal showed no gain in body weight and the remaining animal showed expected gain in body weight during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.0, 0.0 for cornea score; 0.0, 0.0, 0.0 for iris score; 0.3, 0.3, 0.3 for conjunctivae score and 0.3, 0.3, 0.3 for chemosis score. In this study, the test substance is not an eye irritant in male rabbits.
Conclusion
Under the test conditions, the substance is not classified as irritating to eyes according to CLP Regulation (EC) No. 1272/2008.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation Basic data given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Only basic data given
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3556-4556 g
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): pure - Duration of treatment / exposure:
- No Data
- Observation period (in vivo):
- 3 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: Draize
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: No effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: No effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all three animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effects
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- November 20th, 1990 - November 23th, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD) Limited details on test substance
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : Limited details on test substance
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole du Val de Selle
- Weight at study initiation: 2.6 kg
- Housing: individually
- Diet: ad libitum; Rabbits substance ref. 112 C
- Water: ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - 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:
- single dose, no rinsing
- Observation period (in vivo):
- 3 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: according to 84/499/EEC appendix V B5
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: 24 h, 48 h and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- 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: analogue substance
- Justification for type of information:
- Eye irritation in vivo does not need to be investigated because available data indicate that structural variation does not influence test results or adverse effect profile (see read-across and category justifications attached in Section 13).
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
Referenceopen allclose all
Results table is attached.
No corneal or iridial effects were observed. Conjunctival effects included slight redness (one animal) and slight discharge (one animal) were transiently seen approx. one hour after dosing.
Animal |
Hours after application |
|||||||||||||||||||
1 |
24 |
48 |
72 |
|||||||||||||||||
A |
B |
C |
D |
E |
A |
B |
C |
D |
E |
A |
B |
C |
D |
E |
A |
B |
C |
D |
E |
|
01 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
03 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
A = Cornea Score
B = Iris Score
C = Erythema Score
D = Chemosis Score
E = Exsudation Score
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There is no specific data on the substance. Read-across to the properties of Hexanoic acid, 3,5,5-trimethyl-, 1,1'-[2-ethyl-2-[[(3,5,5-trimethyl-1-oxohexyl)oxy]methyl]-1,3-propanediyl] ester (EC 613-848-7, CAS65870-94-2),Fatty acid polyols (Fatty acids, C5-9, esters with pentaerythritol (EC 270-290-3, CAS 68424-30-6) and Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (EC 234-392-1, CAS 11138-60-6)) and their analogues is applicable based on the similarity in structure and physico-chemical properties. The justification for read-across is presented in Section 13 Assessment reports- Read-across justification.
Skin Irritation
One reliable study is available. In this study (Sanders, 2013) performed under GLP according to OECD TG 404 and EC Method B.4, three male New Zealand White rabbits were exposed to 0.5 mL of the analogue substance (EC 613 -848 -7) for 4 hours under semi-occlusive conditions. After removal of the residual test item, irritation was scored immediately following removal of the patches and approximately 1, 24, 48 and 72 h later, according to Draize method. Very slight erythema was noted at two treated skin sites 1 and 24 h after patch removal. No evidence of skin irritation was noted at one treated skin site during the study. All animals showed expected gain in body weight during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.3, 0.3 for erythema and 0.0, 0.0, 0.0 for oedema score, respectively. The mean erythema and oedema scores at 24, 48 and 72 h were 0.22 and 0.0 respectively. The substance is not a skin irritant in male rabbits.
In a supporting study, 2,2-bis[(octanoyloxy)methyl]butyl decanoate (EC 234 -392 -1) was tested for its skin irritation potential according to OECD Guideline 404 (Clouzeau, 1990): The shaved back of three New Zealand White rabbits was exposed to 0.5 mL test material for 4 hours under semi-occlusive conditions. The rabbits were observed for 3 d after exposure and skin reactions were assessed using the Draize scheme periodically (24, 48 and 72 hours) after removal of the test substance. No cutaneous reactions were observed in any of the tested animals at any observation interval.
Furthermore, the result of an acute dermal toxicity study on CAS 131459-39-7 which was conducted according to OECD 402 (Allen, 1999) can be used for risk evaluation of the irritation potential and supports the view that a non-classification of fatty acid polyol esters with short chain length of the fatty acids is warranted for skin irritation. This fatty acid polyol is composed of C5 -C9 fatty acids with pentaerythritol. A single dose of 2000 mg/kg bw of the test material was applied on the shaved skin of five Sprague-Dawley rats for 24 h under semiocclusive conditions and, in addition to mortality and systemic effects, the skin reactions were observed for up to 14 days after exposure. None of the animals showed any signs of skin reaction (erythema/edema/scale) after exposure to this limit dose.
Eye Irritation
One reliable study is available. In this study (Sanders, 2013) performed under GLP according to OCED TG 405 and EC Method B.5, three male New Zealand White rabbits were exposed to 0.1 mL of the analogue substance (EC 613 -848 -7) in the right eye while the left eye remained untreated and served as control. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h after treatment and graded according to the Draize method. No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 h observation. All treated eyes appeared normal at the 48 h observation. One animal showed body weight loss, one animal showed no gain in body weight and the remaining animal showed expected gain in body weight during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0, 0.0, 0.0 for cornea score; 0.0, 0.0, 0.0 for iris score; 0.3, 0.3, 0.3 for conjunctivae score and 0.3, 0.3, 0.3 for chemosis score. In this study, the substance is not an eye irritant in male rabbits.
In a supporting study, 2,2-bis[(octanoyloxy)methyl]butyl decanoate (EC 234 -392 -1) was tested for its eye irritation potential according to OECD Guideline 405 (Clouzeau, 1990): 0.1 mL of the test material were instilled into the conjunctival sac of one eye of three New Zealand White rabbits. Animals were observed for 72 hours and observed effects were scored 24, 48 and 72 hours after instillation according to 84/499/EEC appendix V B5 (Draize). No effects, except for one animal with a very slight exudation reaction at the 24 h time point, were observed in any of the tested animals at any relevant observation interval.
Fatty acids, C5-10, esters with pentaerythritol (CAS No. 68424-31-7) were tested for eye irritation potential according to OECD Guideline 405 (Robinson, 1991): 0.1 mL of the test material was instilled into the conjunctival sac of one eye of three New Zealand White rabbits. Animals were observed for 72 hours. Irritation was scored 24, 48 and 72 hours after instillation according to the method of Draize. No corneal or iridial effects were observed. Conjunctival effects included slight redness (one animal) and slight discharge (one animal) were transiently seen approx. one hour after dosing but were completely reversible within the first 24 h.
Justification for classification or non-classification
According to the CLP criteria for classification and labelling the analogue test items are not classified as skin or eye irritants.
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