Registration Dossier
Registration Dossier
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EC number: 920-008-6 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Acute Toxicity-Oral LD50 > 4150 mg/Kg in rats (OECD TG 401)
Acute Toxicity-Dermal LD50 >
1700 mg//Kg in rabbits (OECD TG 402)
Acute Toxicity-Inhalation LC50 >
13.1 mg/L (13100 mg/m3) (OECD TG 403)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985/07/11-1985/07/31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 423 guideline. GLP
- Justification for type of information:
- Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- only one dose tested
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Males (10); Females (10)
- Weight at study initiation: Males (130-135 g), Females (110-115 g)
- Housing: individual
- Acclimation period: 6d - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A single dose of BP83HF (5 ml/kg; converted to 4.15 g/kg) was administered by oral gavage. An additional group of 5 males and 5 females were sham - dosed and acted as controls.
- Doses:
- 5 ml/kg (converted to 4.15 g/kg)
- No. of animals per sex per dose:
- Male (10), Female (10); total animals (20)
- Control animals:
- yes
- Details on study design:
- The acute oral toxicity of BP83HF was investigated in a group of 5 male and 5 female CD rats of the Sprague - Dawley strain. Each animal received a single oral dose of 5 ml/kg (converted to 4.15 g/kg) administered by gavage. An additional group of 5 males and 5 females were 'sham - dosed and acted as controls. The condition of all animals was observed over a 14 day period following dosing.
- Statistics:
- Differences between treated and control group mean values for bodyweight gains were analyzed by Student t-test. When individual variance ratios were significant (P < 0.05), Cochran's approximation was applied (Snedecor and Cochran, 1973) .
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 150 mg/kg bw
- Remarks on result:
- other: (converted from 5 mL/kg bw) no mortality noted
- Mortality:
- No mortality was observed in any of the animals treated with 5 ml/kg (converted to 4.15 g/kg) of BP83HF.
- Clinical signs:
- other: Transient staining of the urogenital region with test material was observed in all test rats within 24 hours of dosing. Slight flaking of the skin on the feet of these, first noted on Day 7, resolved in most animals prior to termination. During days 0-2,
- Gross pathology:
- Macroscopic post mortem examination of all animals killed at termination (Day 14) revealed no findings considered to be related to treatment. Although a haemorrhagic focus was seen in the fore-stomach of a female dosed with the test material, this lesion was minimal and was considered to be incidental to treatment with the test material.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant 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:
The acute toxicity of BP83HF was evaluated in rats via oral gavage at a dose of 5 ml/kg bw(converted to 4.15 g/kg). Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms. The animals displayed little or no abnormalities. The LD50 for BP83HF following oral gavage was >5 ml/kg (converted to 4.15 g/kg). Classification as an oral toxicant 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:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 0, 15000 mg/kg
- Control animals:
- yes
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 15 000 mg/kg bw
- Mortality:
- no mortality noted
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 was > 15000 mg/kg.
- Executive summary:
The LD50 was > 15000 mg/kg.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 150 mg/kg bw
- Quality of whole database:
- Two key read across studies from structural analogues available for assessment.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given:comparable to guidelines/standards.
- Justification for type of information:
- Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd., Manston, Kent, UK
- Age at study initiation: 7-8 weeks
- Housing: tubular glass chamber, 2 of each sex
- Diet (e.g. ad libitum): ad libitum, except during 4 hr exposure period
- Water (e.g. ad libitum): ad libitum, except during 4 hr exposure period - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: tubular glass chamber
- System of generating particulates/aerosols: dynamically
TEST ATMOSPHERE
- Brief description of analytical method used: continuously by a high temperature total hydrocarbon analyser - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 13.1 mg/l (near saturation)
- No. of animals per sex per dose:
- 2
- Details on study design:
- - Duration of observation period following administration: 14 days
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 13.1 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: near saturation level
- Mortality:
- None
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The LC50 for inhalation toxicity in rats is > 13.1 mg/l, which is near the maximum attainable vapor concentration. The LC50 for the test substance is greater than the saturation concentration.
- Executive summary:
This study examined the inhalation toxicity of Dilutine M5 to rats. Two male and two female rats were exposed to test atmosphere containing near saturation concentration of the test substance vapors (13.1 mg/l air) for 4 hrs. After exposure, the rats were observed for the next 14 days for mortality. No rats died during the course of the study. Therefore, the LC50 for the test substance is > 13.1 mg/l air. Since this concentration is near the saturation concentration, the LC50 is greater than the saturation concentration. The test substance is not toxic via inhalation, and is not classified an inhalation toxin under OECD GHS or EU CLP guidelines.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 13 100 mg/m³ air
- Quality of whole database:
- One key and one supporting read across study from structural analogues available for assessment.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1985-07-11 to 1985-07-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles: GLP
- Justification for type of information:
- Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- used occlusive wrap
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles Rivers UK Ltd
-Sex: Male (10); Female (10)
- Age at study initiation: 6 weeks
- Weight at study initiation: Male: 125-135g; Female: 110-115g
- Housing: individually housed
- Diet (e.g. ad libitum): No. 1, expanded pelleted maintenance diet for rats and mice from Special Diet Services Ltd., ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6-day acclimatisation
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25
- Humidity (%): 58-90
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- On the day prior to application the trunk of each animal was clipped free of hair. For each treated animal, 2 mL/kg of BP83HF was applied to a patch of absorbent paper. The patch was applied to the trunk and held in place beneath a polythene sleeve under a Poroplast bandage. The whole patch assembly was held in place with tape. The patches were left in position for approximately 24 hours. Patches were similarly applied to control animals with the omission of test material. To prevent the animals from gaining access to the sites of application (and hence possibly ingesting traces of test material), collars were applied around the animals heads for a further 24 hours (control and test animals).
- Duration of exposure:
- 24 hours
- Doses:
- Control: (5) males; (5) female
2 ml/kg (converted 1.7 g/kg): (5) males; (5) females - No. of animals per sex per dose:
- Animals: (10) males; (10) female per dose for a total of 20 animals
- Control animals:
- yes
- Details on study design:
- SCORING SYSTEM: Draize scale
- Dermal response observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Differences between treated and control group mean values for bodyweight gain were analysed by Student's t-test. Where individual variance ratios were significant (P <0.05 or less), Cochran's approximation was applied (Snedecor and Cochran, Statistical Methods, 6th Ed. Iowa State. 1973). Where zero variance was found in one or more groups, intergroup comparison was performed by the Wilcoxon Rank Sum Test.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 700 mg/kg bw
- Remarks on result:
- other: (dose converted from >2 mL/kg bw)
- Mortality:
- There were no animal deaths prior to study termination.
- Clinical signs:
- other: Well-defined erythema was noted upon removal of the test patches in all animals exposed to BP83HF, generally persisting for a further 24 hours. Scab formation was subsequently observed on Day 5 and skin flaking was noted on Day 6 in all treated animals, p
- Gross pathology:
- Post mortem examination of all animals killed at termination revealed an area of diffuse subcutaneous haemorrhage beneath the dorsal patch site in one male exposed to BP83HF. However, no other findings considered to be related to treatment were observed and no tissues were processed further for histopathological examination.
- Other findings:
- GROSS POSTMORTEM EXAMINATION
No alterations were noted. - Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of BP83HF was > 2 ml/kg (converted 1.7 g/kg). Classification as an acute dermal toxicant 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:
Five male and five female rabbits were exposed to BP83HF for 24h via an occluded patch. Dermal evaluations occurred at 24 hours post patch removal and once daily until the study termination at day14. Exposure had no effect on viability; all animals survived the exposure. The LD50 of BP83HF was > 2 ml/kg (converted 1.7 g/kg). Classification as an acute dermal toxicant 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:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given:comparable to guidelines/standards.
- Justification for type of information:
- Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: Noakes, DN, and Sanderson, DM (1969). A method for determining the dermal toxicity of pesticides. Br. J. Industr. Med., 26, 59-64.
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Manston, Kent - Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1, 2, or 4 ml/kg - Duration of exposure:
- 24 hrs
- Doses:
- 1, 2, 4 ml/kg
- No. of animals per sex per dose:
- 2 animals of each sex per dose
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 mL/kg bw
- Mortality:
- No animals died during the study.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The dermal LD50 for rats is > 4 ml/kg (~3400 mg/ kg bw).
- Executive summary:
This study examined the acute toxicity of Dilutine M5 to rats via dermal exposure. 2 female and 2 male rats were exposed to 1, 2, or 4 ml/kg of undiluted test material dermally for 24 hrs. No rats died during the experiment. The dermal LD50 for rats is > 4 ml/kg (~3400mg/kg bw).
Referenceopen allclose all
Mortality
Dose ml/kg |
Males |
Female |
Total |
1 |
0/2 |
0/2 |
0/4 |
2 |
0/2 |
0/2 |
0/4 |
4 |
0/2 |
0/2 |
0/4 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 700 mg/kg bw
- Quality of whole database:
- Two key studies from structural analogues available for assessment.
Additional information
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
No acute oral, inhalation, or dermal toxicity data is available for Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). However, data is available for structural analogues, Hydrocarbons, C9-C10, n-alkanes, isoalkanes, cyclics, aromatics (2-25%);
Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%); Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%); and C9-C14 aliphatic solvents, 2-25% aromatic. 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.
Acute Oral Toxicity
Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%)
In a key study (DHC Solvent Chemie GmbH, 1985), the acute toxicity of the test material (Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%)) was evaluated in rats via oral gavage at a dose of 5 ml/kg bw (converted to 4.15 g/Kg). Observations were made as to the nature, onset, severity, and duration of toxicological signs once per day for a total of 14 days. All animals survived the entire observational period and displayed a low incidence of clinical symptoms. The animals displayed little or no abnormalities. The LD50for the test material following oral gavage was >5 ml/Kg (converted to 4.15 g/Kg). Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Hydrocarbons, C9-C10, n-alkanes, isoalkanes, cyclics, 2-25% aromatics
In a key acute oral toxicity (ExxonMobil, 1977a), male and female rats were exposed via oral gavage to the hydrocarbons, C9 -C10, n-alkanes, isoalkanes, cyclics, 2-25% aromatics at doses of 0 or 15000 mg/Kg. Based on the lack of effects of mortality observed, the LD50 was determined to be >15000 mg/Kg bw.
Acute Inhalation Toxicity
Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics
A key acute toxicity study (Shell, 1977a) examined the inhalation toxicity of hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics in rats. Two male and two female rats were exposed to test atmosphere containing near saturation concentration of the test substance vapors (13.1 mg/L air) for 4 hrs. After exposure, the rats were observed for the next 14 days for mortality. No rats died during the course of the study. Therefore, the LC50 for the test substance was determined to be > 13.1 mg/L air. Since this concentration is near the saturation concentration, the LC50 is greater than the saturation concentration. The test substance is not toxic via inhalation, and is not classified an inhalation toxin under OECD GHS or EU CLP guidelines.
C9-C14 aliphatic solvent (2-25% aromatics)
A supporting study (Sasol, 1990) examined the toxicity of a C9-C14 aliphatic solvent (2-25% aromatics) in rats via aerosol inhalation. Five male and five female rats were exposed to aerosol of the test substance for 4 hrs. The test concentration was 1.58 mg/L, the maximum concentration with 25% of particles under 1 micron. Animals were observed for clinical signs and mortality at 0.5, 1.0, 2.5, 4.5, and 6.0 hrs after start of exposure, and daily thereafter for the next 14 days. Body weights were taken on days 0, 7, and 14. All animals were sacrificed on day 14, and gross necropsies performed. Animals exhibited symptoms of piloerection, activity decrease, ptosis, and polyuria beginning at the 1 hr observation, and persisting in some cases to the 6 hr observation. By the day 1 observation, all symptoms had resolved. No mortality was observed during the experiment. The 4-hr LC50 for rats via inhalation of aerosol was determined to be >1.58 mg/L. The test substance is not classified an inhalation toxin under OECD GHS or EU CLP guidelines.
Acute Dermal Toxicity
Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%)
In a key study (DHC Solvent Chemie GmbH, 1985), five male and five female rabbits were exposed to test material (Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%)) for 24h via an occluded patch. Dermal evaluations occurred at 24 hours post patch removal and once daily until the study termination at day14. Exposure had no effect on viability; all animals survived the exposure. The LD50of the test material was > 2 ml/Kg (converted 1.7 g/Kg). Classification as an acute dermal toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics
A key study (Shell, 1977a) examined the acute toxicity of hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics in rats via dermal exposure. 2 female and 2 male rats were exposed to 1, 2, or 4 mL/Kg of undiluted test material dermally for 24 hrs. No rats died during the experiment. The dermal LD50 for rats was determined to be > 4 mL/Kg (~3400 mg/Kg bw).
Justification for classification or non-classification
Based on the available read across data, Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, 2-25% aromatics is minimally toxic via ingestion where the LD50 is >4150 mg/Kg, via dermal exposure where the LD50 is >1700 mg/Kg, and by inhalation where the LC50 is >13100 mg/m3. These findings do not warrant classification under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, 2-25% aromatics is classified under EU CLP guidelines as a Category 1 aspiration hazard based on its physical and chemical properties (hydrocarbon fluid, viscosity ≤ 20.5 mm2/s).
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.
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