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EC number: 297-628-2 | CAS number: 93685-80-4
- 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
Irritating to the skin
Ocular Irritation
Not irritating to eyes
Respiratory Irritation a
No studies were located to indicate that Hydrocarbon, C4, 1,3-butadiene-free, polymd,, tetraisobutylylene fraction, hydrogenated is a respiratory irritant.
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:
- 2000/10/12-2000/10/18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD test guideline 404. GLP
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar 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:Covance Research Products Inc.
Number of Animals: Three males
Age at study initiation: Approximately 13 weeks
Weight at study initiation: 2.7-3.2 kg
Housing: Individually
Diet (e.g. ad libitum): PMI Cert. Rabbit Diet; limited
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 8d
ENVIRONMENTAL CONDITIONS
Temperature (°F): 64 to 72
Humidity (%): 30 to 70%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat - Duration of treatment / exposure:
- Test material was administered to the clipped backs as a single dose introduced under a gauze patch (secured with non-irritating tape) and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
- Observation period:
- 24, 48, and 72h post application and once per day until Day 14
- Number of animals:
- Three males
- Details on study design:
- SCORING SYSTEM: Draize scale for dermal irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- All animals survived to study termination, were free of adverse clinical signs, and displayed normal body weight patterns during the test period.
Topical application of the test substance to the skin of rabbits elicited dermal irritation in all animals during the study. Erythema and edema were observed in all animals.
Erythema started as Grade 2 erythema in all animals at the 60-minute evaluation and remained the same at the 24-hour evaluation. Erythema increased slightly at the 48- hour evaluation when two animals displayed Grade 2 erythema and one animal displayed Grade 3 erythema. Erythema reached its maximum severity at the 72- hour evaluation when one animal displayed Grade 2 erythema and two animals displayed Grade 3 erythema. Erythema subsided after the 72-hour evaluation and on Days 7 and 10 all animals displayed Grade 1 erythema. At the Day 14 evaluation one animal displayed Grade 1 erythema.
Edema was first noted and was most severe at the 60-minute evaluation. Grade 2 edema was noted for all animals at this interval. Edema decreased slightly at the 24 and 48-hour evaluations when Grade 1 edema was noted in two animals and Grade 2 edema was noted in one animal. Edema increased slightly at the 72-hour evaluation when one animal displayed Grade 1 edema and two animals displayed Grade 2 edema. At the Day 7 evaluation Grade 1 edema was displayed by two animals and Grade 3 edema was displayed for one animal. After the Day 7 evaluation edema subsided. One animal displayed Grade 2 edema at Day 10 and one animal displayed Grade 1 edema at Day 14.
Supplemental dermal observations, which included desquamation and cracking, were noted on Days 7 and 10. Desquamation was noted for all animals at both intervals and cracking was noted for one animal on Day 7. - Interpretation of results:
- other: Irritating
- Remarks:
- R38 Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24, 48, and 72 hours) was 2.33. The average edema score (24, 48, and 72 hours) was 1.1. The test material would be classified as a Category 2 dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). The test material would be classified as an R38 dermal irritant under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
In this study, 3 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of MRD-00-710 via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring. Topical application of MRD-00-710 elicited dermal responses in all animals. Well defined erythema and slight odema followed exposure. The average erythema score (24, 48, and 72 hours) was 2.33. The average edema score (24, 48, and 72 hours) was 1.1. The test material would be classified as a Category 2 dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP). The test material would be classified as an R38 dermal irritant under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997/10/08-1997/10/19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD test guideline 404. GLP
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar 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: Elevage Cunicole de Val de Selle
Number of Animals: Three males
Age at study initiation: Approximately 13 weeks
Weight at study initiation: 2.6 +/-0.1 kg
Housing: Individually
Diet (e.g. ad libitum): 112 C pelleted diet
Water (e.g. ad libitum): Automatic watering system, ad libitum
Acclimation period: 8d
ENVIRONMENTAL CONDITIONS
Temperature (°C): 15-21
Humidity (%): 30 to 70%
Photoperiod (hrs dark / hrs light): 12/12
Monitored at least once a day - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Amount(s) applied (volume or weight): 0.5 ml
Concentration (if solution): neat - Duration of treatment / exposure:
- Test material was administered to the clipped backs as a single dose introduced under a gauze patch (secured with non-irritating tape) and held in contact with the skin by means of a semi-occlusive dressing for 4 hours. Residual test material was then removed.
- Observation period:
- 24, 48, and 72h post application and once per day until Day 14
- Number of animals:
- Three males
- Details on study design:
- SCORING SYSTEM: Draize scale for dermal irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.53
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- A very slight or well-defined erythema was observed in all animals from day 1 up to day 9 or 10. A slight oedema was noted in two animals on day 1 only. Dryness of the skin was recorded in all animals from day 4or 5 up to day 1 or 11. Mean scores over 24, 48 and 72 hours for each animal were 1.3, 1.3 and 2.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
In this study, 3 rabbits were subjected to a 4h dermal (shaved) exposure of 0.5 ml of ECOLANE 90 via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring. A very slight or well-defined erythema was observed in all animals from day 1 up to day 9 or 10. A slight oedema was noted in two animals on day 1 only. Dryness of the skin was recorded in all animals from day 4 or 5 up to day l or 11. Mean scores over 24, 48 and 72 hours for each animal were 1.3, 1.3 and 2.0 for erythema and 0.0, 0.0 and 0.0 for oedema. Classification as a dermal irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- 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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000/03/08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: GLP.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across: supporting information
- 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
- Source: Harlan UK Ltd
- Age at study initiation: 13 weeks
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individual
- Diet (e.g. ad libitum): Special Diet Services STANRAB SQC pellet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 25 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 -23
- Humidity (%): 36-45
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: contralateral eye
- Amount / concentration applied:
- 0.1mL
- Duration of treatment / exposure:
- The eyelids were gently held together for one second before releasing.
- Observation period (in vivo):
- 1, 24, 48, and 72 hours post-treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Test material was applied to the eyes and the eyelids were gently held together for one second before releasing. Irritation and toxicity were monitored at 1, 24, 48, and 72 hours post-treatment. Irritation was scored according to the Draize methodology.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No corneal damage or iridial inflammation was observed. Only slight signs of irritation were observed in the rabbits.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The mean conjunctivae, chemosis, iris, and cornea scores for the Sample V were 0.0, 0.0, 0.0, and 0.0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
Sample V (0.1 mL, neat) was administered to the right eye of three rabbits to assess for occular irritation. Irritation and toxicity were monitored at 1, 24, 48, and 72 hours post-treatment. Irritation was scored according to the Draize methodology. No corneal damage or iridial inflammation was observed. Only slight signs of irritation were observed in the rabbits. The mean conjunctivae, chemosis, iris, and cornea scores for sample V were 0.0, 0.0, 0.0, and 0.0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- 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
Referenceopen allclose all
Irritation parameter | Basis | Time Point | Score |
conjuctivae score | animal #1 | 24 hours | 0 |
conjuctivae score | animal #2 | 24 hours | 0 |
conjuctivae score | animal #3 | 24 hours | 0 |
conjuctivae score | animal #1 | 48 hours | 0 |
conjuctivae score | animal #2 | 48 hours | 0 |
conjuctivae score | animal #3 | 48 hours | 0 |
conjuctivae score | animal #1 | 72 hours | 0 |
conjuctivae score | animal #2 | 72 hours | 0 |
conjuctivae score | animal #3 | 72 hours | 0 |
conjuctivae score | mean | 24 hour mean | 0 |
conjuctivae score | mean | 48 hour mean | 0 |
conjuctivae score | mean | 72 hour mean | 0 |
conjuctivae score | mean | 24-72 hour mean | 0 |
chemosis score | animal #1 | 24 hours | 0 |
chemosis score | animal #2 | 24 hours | 0 |
chemosis score | animal #3 | 24 hours | 0 |
chemosis score | animal #1 | 48 hours | 0 |
chemosis score | animal #2 | 48 hours | 0 |
chemosis score | animal #3 | 48 hours | 0 |
chemosis score | animal #1 | 72 hours | 0 |
chemosis score | animal #2 | 72 hours | 0 |
chemosis score | animal #3 | 72 hours | 0 |
chemosis score | mean | 24 hour mean | 0 |
chemosis score | mean | 48 hour mean | 0 |
chemosis score | mean | 72 hour mean | 0 |
chemosis score | mean | 24-72 hour mean | 0 |
cornea score | mean | 24-72 hour mean | 0 |
iris score | mean | 24-72 hour mean | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There is no data available for Hydrocarbon, C4, 1,3-butadiene-free, polymd,, tetraisobutylylene fraction, hydrogenated. However, data is available for structural analogues, Hydrocarbons, C10-C12, isoalkanes, <2% aromatics, and isohexadecane. This data is read across to based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.
Skin Irritation
Hydrocarbons, C10-C12, isoalkanes, <2% aromatics
In a key study (Exxonmobil Corp., 2004), 3 rabbits were subjected to a 4 hour dermal (shaved) exposure of 0.5 ml of Hydrocarbons, C10-C12, isoalkanes, <2% aromatics via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring. Topical application of the test material elicited dermal responses in all animals. Well defined erythema and slight odema followed exposure. The average erythema score (24, 48, and 72 hours) was 2.33. The average edema score (24, 48, and 72 hours) was 1.1.
In another key study (TOTAL Fuides, 1998), 3 rabbits were subjected to a 4 h dermal (shaved) exposure of 0.5 ml of Hydrocarbons, C10-C12, isoalkanes, <2% aromatics via a semi-occluded patch. Dermal responses were evaluated at 1, 24, 48, and 72h post-dosing and once a day for a total of 14 days according to the Draize method of scoring. A very slight or well-defined erythema was observed in all animals from day 1 up to day 9 or 10. A slight oedema was noted in two animals on day 1 only. Dryness of the skin was recorded in all animals from day 4 or 5 up to day l or 11. Mean scores over 24, 48 and 72 hours for each animal were 1.3, 1.3 and 2.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
In a supporting study (Exxonmobil Corp, 1991), fifteen human volunteers received one application of the test material (Hydrocarbons, C10-C12, isoalkanes, <2% aromatics) under semi-occlusive conditions. The sample remained in contact with the skin for 24 hours and was removed by the laboratory staff. Sites were graded approximately thirty minutes after patch removal, and again 24 hours after the initial patch removal. Under the conditions of this test, the test material was considered an irritant.
Isohexadecane
In a supporting study (Hill Top Research, Inc., 1994), a clinical test including 15 human volunteers was conducted and isohexadecane applied undiluted on upper arm in occlusive conditions (patch) for 24 h. Skin reactions were scored 30 min and 24 h after removal of the patch. Mild signs of irritation were observed in only 3 volunteers and only slight signs of irritation in 8 volunteers in worse conditions (24-h exposure, occlusive conditions), leading to the conclusion that isohexadecane is not an irritant for the human skin.
In another supporting study (INEOS, 1980), the skin irritating properties of isohexadecane was assessed in White Vienna rabbits (3 animals of both sexes). The test substance was applied on a wipe put in contact with the shaved skin under semi-occlusive dressing for 24 hours. At the end of exposure, skin reactions were recorded both at 24 hours (patch removal) and 48 hours after the end of exposure (i.e. 72 -hour time observation) according to the Draize scale. Complete observation time was 14 days. Moreover, the behavior, general state and food consumption were also observed. Body weight was measured every day. There was a very slight erythema (score 1) in two rabbits at patch removal (observation time = 24h). At the 72-hour observation, no erythema was observed in all 6 animals. No oedema was noted in any animal at any observation time. No systemic effect was observed following exposure to isohexadecane. Behavior, general state, fur, food consumption and body weight development were normal. Under these test conditions, the substance was not classified as a skin irritant according to CLP Regulation 1272/2008.
Ocular Irritation
Hydrocarbons, C10-C12, isoalkanes, <2% aromatics
In a key study (TOTAL Solvants, 1998), the test material (0.1 mL, neat) was administered to the right eye of three rabbits to assess for ocular irritation. Irritation and toxicity were monitored at 1, 24, 48, and 72 hours post-treatment. Irritation was scored according to the Draize methodology. No corneal damage or iridial inflammation was observed. Only slight signs of irritation were observed in the rabbits. The mean conjunctivae, chemosis, iris, and cornea scores were 0.0, 0.0, 0.0, and 0.0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP.
Isohexadecane
In a supporting study (INEOS, 1980), the irritant potential of the substance isohexadecane was assessed by applying 0.1 mL of the test substance in the conjunctival sac of the left eye of 6 male Himalayan rabbits. After application the animals lid were kept closed for 1 second. The right eye was used as control and received 0.1 mL of physiological NaCl solution. The eyes were examined and the changes were graded according to a numerical scale at 15 min, 1, 24, 48 and 72 hours after dosing. No conjunctival chemosis, corneal and iridial lesion were observed throughout the observation period. Slight redness of the conjunctivae was observed in all animals at 1 hour but only in one animal by the 24 hours after instillation. At 48-hour observation period, no redness was observed in any rabbit. Hence, the mean individual score for redness was 0.33-0.0-0.0. Isohexadecane is not classified as eye irritant according to CLP Regulation 1272/2008.
Respiratory Irritation
No studies were located to indicate that Hydrocarbon, C4, 1,3-butadiene-free, polymd,, tetraisobutylylene fraction, hydrogenatedi s a respiratory irritant.
Justification for classification or non-classification
Skin Irritation:
Based on available read across data, Hydrocarbon, C4, 1,3-butadiene-free, polymd,, tetraisobutylylene fraction, hydrogenated does not meet the criteria for classification for skin Irritation under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Ocular Irritation:
Based on available read across data, Hydrocarbon, C4, 1,3-butadiene-free, polymd,, tetraisobutylylene fraction, hydrogenated does not meet the criteria for classification as ocular irritants under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Respiratory Irritation:
There are no studies that warrant classification as a respiratory irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.