Registration Dossier
Registration Dossier
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EC number: 279-420-3 | CAS number: 80206-82-2
Endpoint summary
Administrative data
Description of key information
- Acute oral toxicity: The acute oral LD50 in male/female rats is >10000 mg/kg bw . No significant gross abnormalities were seen at autopsy. )). This show that Alcohols, C12-14 is practically nontoxic for acute oral toxicity. Alcohols, C12-14 was not classified according to EU or GHS criteria.
-Acute Dermal Toxicity: The rabbit dermal LD50 of Alcohols, C12-14 was > 2000 mg/kg. This show that Alcohols, C12-14 is not toxic for acute Dermal toxicity . Alcohols, C12-14 was not classified according to EU or GHS criteria
-Acute inhalation toxicity :The 4 hour rat inhalational LC50 for Alcohols, C12-14 is >saturated vapour concentration. There were no signs of toxicity during exposure or the subsequent observation period..The rat 4 hour LC50 for Alcohols, C12-14 is > saturated vapour concentration.
Results indicate that Alcohols, C12-14 is not toxic for acute inhalation toxicity. Alcohols, C12-14 was not classified according to EU or GHS criteria.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Method: other: in house procedure
- GLP compliance:
- yes
- Test type:
- other: LD50
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS: Rat (Wistar)
- Source: not reported
- Weight at study initiation: mean weight 190g
- Group size: 10 F
- Controls: no - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- ADMINISTRATION: Gavage
- Doses: 5 and 10g/kg
- Doses per time period: Single
- Volume administered or concentration: 20 ml/kg constant dose as a solution in olive oil
- Post dose observation period: 14 days
EXAMINATIONS: The animals were observed for mortality and clinical signs. - Doses:
- 5000 and 10000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- ADMINISTRATION: Gavage
- Doses: 5 and 10g/kg
- Doses per time period: Single
- Volume administered or concentration: 20 ml/kg constant dose as a solution in olive oil
- Post dose observation period: 14 days - Statistics:
- No statistical analysis of the results was carried out in this study.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths during the study.
- Clinical signs:
- other: No signs of intoxiciation
- Other findings:
- NECROPSY FINDINGS: Necropsy not carried out.
POTENTIAL TARGET ORGANS: No indication given.
SEX-SPECIFIC DIFFERENCES: Only females teste - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rat oral LD50 for this C12-14 alcohol Lorol Spezial type 70 was >10000 mg/kg. There were no signs of intoxication.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- rat (CD)
- Source: Charles River, Margate, Kent, UK
- Age: 5 weeks
- Weight at study initiation: mean weight prior to fasting males 117-121g, females 108-116g
- Group size: 5M+5F
- Controls: no - Route of administration:
- oral: gavage
- Vehicle:
- other: maize oil
- Details on oral exposure:
- ADMINISTRATION:
- Doses: gavage, animals fasted
- Doses per time period: single
- Volume administered or concentration: 10 ml/kg in maize oil.
- Post dose observation period: 14 days - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5M+5F
- Control animals:
- no
- Details on study design:
- ADMINISTRATION:
- Doses: gavage, animals fasted
- Doses per time period: single
- Volume administered or concentration: 10 ml/kg in maize oil.
- Post dose observation period: 14 days
EXAMINATIONS:
The rats were observed twice in the hour immediately after dosing and twice more on the day of dosing.
Thereafter the animals were observed twice daily and any observations recorded once a day.
Body weights were recorded on days 1, 8 and 15 when the animals were sacrificed.
Gross examination was made of the viscera at the end of the observation period. - Preliminary study:
- There were no deaths or clinical signs of toxicity. Based on this information a dose level of 2000 mg/kg bw was selected for the main study.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: There were no clinical signs of intoxication.All animals gained bodyweight as expected over the observation period.
- Gross pathology:
- NECROPSY FINDINGS: No adverse effects.
- Other findings:
- POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 value of >2000 mg/kg bw is reported in a reliable study conducted according to the appropriate guideline.
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- other: LD50
- 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 River (UK) Ltd., Margate, Kent, UK.
- Age at study initiation: 5-8 weeks
- Weight at study initiation: Males 135-145g, females 127-137g.
- Fasting period before study: Overnight, immediately before dosing.
- Housing: Housed in groups of up to five by sex in solid floor polypropylene cages furnished in woodflakes.
- Diet: Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK (ad libitum)
- Water: Mains drinking water (ad libitum)
- Acclimation period: Minimum of five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22C
- Humidity (%): 39-60%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h/12h - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg at a concentration of 200 mg/ml in arachis oil.
- Lot/batch no. (if required): 2439
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bodyweight. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
DOSAGE PREPARATION (if unusual): All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A range finding study was carried out prior to dosing, using 1 male and 1 female rat which were administered 200 mg/kg of test substance at the concentration of 200 mg/ml in the volume of 10 ml/kg. The animals were observed for deaths and overt signs of toxicity 30 min, 1h, 2h and 4 hrs after dosing and subsequently for five days. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded prior to dosing on dayy 0 and on days 7 and 14. The animals were observed for deaths or overt signs of toxicity at 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Necropsied animals were examined externally and their abdominal and thoracic cavities opened for the examination of major organs. No tissues were retained. All animals were subject to gross pathological examination at the end of the observation period. - Statistics:
- No statistical analysis of the results was carried out in this study.
- Preliminary study:
- A range finding study was performed to establish a dosing regime as follows: 2000 mg/kg at the concentration of 200 mg/ml in dose volume of 10 ml/kg to 1 male and 1 female rat. The rats were observed for overt signs of toxicity at 30min, 1h,2h and 4hrs after dosing subsequently once daily for five days.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No clinical signs of systemic toxicity.
- Gross pathology:
- Necropsy findings were unremarkable
- Other findings:
- POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None observed. - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rat oral LD50 for Kalcol 6098 is >2000 mg/kg. At this dose level there were no signs of toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- other: LD50
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- rat (Wistar)
- Source: Winkelmann, Hanover, Germany
- Weight at study initiation: average body weight males 156g,females 136g.
- Group size: 5M+5F fasted
- Controls: no - Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous suspension
- Details on oral exposure:
- ADMINISTRATION: gavage animals fasted
- Doses: 5 g/kg
- Doses per time period: single
- Volume administered or concentration: 20 ml/kg of a 25% aqueous suspension.
- Post dose observation period: 14 days
EXAMINATIONS: Clinical signs were observed at 1, 4 and 24 hours after dosing and then daily thoughout the obsrvation period. Body weights were recorded immediately prior to dosing and at 24 hours, 1 week and two weeks after dosing. All survivors were subject to gross necropsy. - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- ADMINISTRATION: gavage animals fasted
- Doses: 5 g/kg
- Doses per time period: single
- Volume administered or concentration: 20 ml/kg of a 25% aqueous suspension.
- Post dose observation period: 14 days - Statistics:
- No statistical analysis of the results was carried out in this study.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the course of the study.
- Clinical signs:
- other: Slight sedation and piloerection in all test animals during the first 24 hours after dosing. The animals gained in bodyweight at all measurement points during the observation period.
- Gross pathology:
- Nothing remarkable
- Other findings:
- POTENTIAL TARGET ORGANS: None identified
SEX-SPECIFIC DIFFERENCES: None - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rat oral LD50 for Lorol 12 applied as an aqueous suspension was >5000 mg/kg. Signs of intoxication were confined to mild sedation and piloerection on the day of dosing. There were no gross histopathological changes and no evidence of specific target organ toxicity.
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- other: LD50
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS:
- rat (Wistar)
- Source: Winkelmann, Hanover, Germany
- Weight at study initiation: average body weight males 174g,females 144g.
- Group size: 5M+5F fasted
- Controls: no - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- ADMINISTRATION:
-gavage
- Doses: 5000 mg/kg
- Doses per time period: single
- Volume administered or concentration: 10 ml/kg as a 50% suspension in olive oil.
- Post dose observation period: 14 days.
EXAMINATIONS: Mortality and clinical signs were recorded. Body weights were taken before dosing and at 24 hours, 1 and 2 weeks after dosing.
All rats were subject to gross necropsy at the end of the observation period. - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- ADMINISTRATION:
-gavage
- Doses: 5000 mg/kg
- Doses per time period: single
- Volume administered or concentration: 10 ml/kg as a 50% suspension in olive oil.
- Post dose observation period: 14 days. - Statistics:
- No statistical analysis of the results was carried out in this study.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the observation period.
- Clinical signs:
- other: Slight sedation and piloerection were observed during the first 24 hours after dosing in all rats. The average body weight of the groups of male and female rats increased over the observation period.
- Gross pathology:
- Unremarkable.
- Other findings:
- POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None observed. - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rat oral LD50 for Lorol (Lanette) 16 is >5000 mg/kg. Clinical signs were confined to slight sedation and piloerection in the first 24 hours after dosing. Also reported in Iuclid 2000.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: in house protocol
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS: Rat (Wistar)
- Source: Shell Toxicology Laboratory (Tunstall) Breeding Unit, Sittingbourne, Kent, UK
- Age: 8 weeks approx.
- Weight at study initiation: not reported
- Number of animals: 5M+5F
- Controls: none - Route of administration:
- other: mist
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: Condensation mist atmosphere
- Details on inhalation exposure:
- ADMINISTRATION:
- Type of exposure: 4 hour inhalation exposure, whole body
- Concentrations: saturated atmosphere (no monitoring reported)
- Particle size: not reported
- Type or preparation of particles: condensation mist
EXAMINATIONS: Clinical signs observed throughout exposure and daily thereafter throughout an observation period of at least 14 days. Initial, 7 and 14 day bodyweights were recorded. - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- saturated atmosphere
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- no
- Details on study design:
- Clinical signs observed throughout exposure and daily thereafter throughout an observation period of at least 14 days. Initial, 7 and 14 day bodyweights were recorded
- Statistics:
- No statistical analysis was carried out on the test results.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.9 ppm
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Type A,. LC50 expected to be > 4.9 ppm (substantially saturated atmospheric concentration)
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 40.08 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa) mg/m3 =ppm x molecular weight /24.45. mg/m3 =4.9x 200/24.45=40.08 mg/m3
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.3 ppm
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Type B. LC50 expected to be > 1.3 ppm (substantially saturated atmospheric concentration)
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 10.6 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa) mg/m3 =ppm x molecular weight /24.45. mg/m3 =1.3 x 200/24.45=10.6 mg/m3
- Mortality:
- All animals survived the 4 hour exposure and subsequent observation period.
- Clinical signs:
- other: There were no signs of toxicity during or after exposure.
- Gross pathology:
- NECROPSY FINDINGS: Not carried out.
- Other findings:
- POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None reported. - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The 4 hour rat inhalational LC50 forAlcohols, C12-14 is >saturated vapour concentration. There were no signs of toxicity during exposure or the subsequent observation period..The rat 4 hour LC50 for Alcohols, C12-14 is > saturated vapour concentration.
- Executive summary:
The rat 4 hour LC50 for Alcohols, C12-14 is > saturated vapour concentration.
Alcohols,C12-14 are expected to be of a low order of acute inhalational toxicity with the LC50 in excess of the saturated vapour concentration
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: in house protocol
- Principles of method if other than guideline:
- Only one dose level, short exposure period, no indication of droplet size.
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: T23-48:COX-SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 245-356g
- Housing: 57 litre capacity glass chamber
- Diet: Purina laboratoy chow (ad libitum)
- Water: yes (ad libitum
IN-LIFE DATES: Not specified. - Route of administration:
- other: mist
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: atmosphere generated as a mist
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Devilbiss Nebulizer
- Exposure chamber volume: 57 litres
- Method of holding animals in test chamber: Free to move in the glass chamber
- Source and rate of air: Delivery flow concentration of approximately 21 mg per litre of air, at a flow rate of six litres per minute.
TEST ATMOSPHERE
- Brief description of analytical method used: Prior to the actual exposure period, the test material was introduced into the chambre for ten minutes in order to make sure the test atmospheric concetration could reach theoretical equilibrium.
- Samples taken from breathing zone: no
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: Droplet size not reported - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 1 h
- Concentrations:
- 21 mg/l
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently for gross effects during the exposure and daily thereafter for 14 days.
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was carried out on the test results.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 21 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Remarks on result:
- other: To convert mg/l into mg/m³ 1 mg/m³=mg/l x 1000, 21mg/lx1000=21000 mg/m³
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 025 ppm
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Remarks on result:
- other: To convert mg/m3 into ppm at 25°C and 760 mm Hg (101.32 kPa) ppm = mg/m3 x (24.45/molecular weight) 21000 x (24.45/102.18)=5025 ppm
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 21 000 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Remarks on result:
- other: To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa) mg/m3 =ppm x molecular weight /24.45. mg/m3 =5025x 102.18/24.45=21000 mg/m3
- Mortality:
- All animals survived the 14 day observation period.
- Clinical signs:
- other: During exposure all animals showed hypoactivity and/or ataxia, lethargy and prostration. However within 2 hours of removal from the exposure chamber the animals all appeared and continued to appear normal throughout the observation period.
- Body weight:
- Final bodyweights showed a slight weight loss in one animal however the others all exhibited weight gains within expected limits.
- Gross pathology:
- Gross necropsy revealed moderate pulmonary, adrenal and hepatic congestion in one animal only. The findings in the remaining
- Other findings:
- No potential target organs were identified.
- Interpretation of results:
- other: practically nontoxic
- Remarks:
- Criteria used for interpretation of results: other: Federal Hazardous Substances Act
- Conclusions:
- The rat inhalational LC50 following a 1 hour exposure to a mist of Alfol 6 was >21 mg/l. Since the test atmospheric concentration would in all probablility exceed that to be encountered by humans when the substance is used, Alfol 6 Alcohol was found not to be a toxic substance.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: in house protocol
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS: Rat (Wistar)
- Source: Shell Toxicology Laboratory (Tunstall) Breeding Unit, Sittingbourne, Kent, UK
- Age: 8 weeks approx.
- Weight at study initiation: not reported
- Number of animals: 5M+5F
- Controls: none - Route of administration:
- other: mist
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: Condensation mist atmosphere
- Details on inhalation exposure:
- ADMINISTRATION:
- Type of exposure: 4 hour inhalation exposure, whole body
- Concentrations: saturated atmosphere (no monitoring reported)
- Particle size: not reported
- Type or preparation of particles: condensation mist
EXAMINATIONS: Clinical signs observed throughout exposure and daily thereafter throughout an observation period of at least 14 days. Initial, 7 and 14 day bodyweights were recorded. - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- saturated atmosphere
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- no
- Details on study design:
- Clinical signs observed throughout exposure and daily thereafter throughout an observation period of at least 14 days. Initial, 7 and 14 day bodyweights were recorded
- Statistics:
- No statistical analysis was carried out on the test results.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.001 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.5 ppm
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4.38 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa) mg/m3 =ppm x molecular weight /24.45. mg/m3 =0.5x 214.2/24.45=4.38 mg/m3
- Mortality:
- All animals survived the 4 hour exposure and subsequent observation period.
- Clinical signs:
- other: There were no signs of toxicity during or after exposure.
- Gross pathology:
- NECROPSY FINDINGS: Not carried out.
- Other findings:
- POTENTIAL TARGET ORGANS: None identified.
SEX-SPECIFIC DIFFERENCES: None reported. - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The 4 hour rat inhalational LC50 for Dobanol 25 is >saturated vapour concentration. There were no signs of toxicity during exposure or the subsequent observation period..The rat 4 hour LC50 for Alcohols, C12-16 is > saturated vapour concentration.
- Executive summary:
The rat 4 hour LC50 for Alcohols, C12-16 is > saturated vapour concentration.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- The study is a read across from tetradecanol (CAS 112-72-1).Tetradecanol (C14) ) is supporting substance for Alcohols,C12-C14 and the one of the component in Alcohols,C12-C14 .
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: In house protocol
- GLP compliance:
- not specified
- Test type:
- fixed concentration procedure
- Limit test:
- no
- Species:
- rat
- Strain:
- other: COX-SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 238-338g
- Housing: A 57 litre capacity glass chamber
ENVIRONMENTAL CONDITIONS
- Air changes (per hr): Air flow rate of 600 litres per hour
IN-LIFE DATES: Not stated - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: produced as a heated vapour
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 57 litres
- Method of holding animals in test chamber: Animals were contained in a glass chamber.
- Source and rate of air: ALFOL 14 alcohol was introduced by passing an air flow over the test material as it was heated in a 60C at an ambient chambre concentration of approximately 1.5mg per litre of air at a flow rate of ten litres per minute for a period of one hour.
TEST ATMOSPHERE
- Samples taken from breathing zone: Prior to the actual test period, the test material was introduced into the chambre for six minutes, in order that the test atmospheric concentration could reach theoretical equilibrium.
VEHICLE
- Lot/batch no. (if required): 8714J
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: The 1.5mg/litre test concentration was chosen since the level does not exceed any to which man could be subjected to in any foreseeable use of the material. - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 1 h
- Concentrations:
- 1.5 mg/l
- No. of animals per sex per dose:
- 5 female, 5 male
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Final body weight records of the ten animals at termination (14 days) showed weight gains within expected limits of that expected in all ten animals. The animals were observed frequently on the day of exposure and daily thereafter. Survivors were weighed and necropsied at the end of the exposure period - Statistics:
- No statistical test was performed.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Mortality:
- There were no mortalities during the exposure itself or in the 14 day observation period.
- Clinical signs:
- other: There were no clinical signs of toxicity present at any point of the study.
- Body weight:
- Body weight gain remained within expected limits for all ten animals.
- Gross pathology:
- Gross necropsy of the animals sacrificed at termination (14 days) showed no remarkable findings.
- Other findings:
- There were no other observations.
- Interpretation of results:
- other: practically nontoxic
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rat 1 hour inhalational LC50 for Alfol 14 is >1.5 mg/l. There were no signs of toxicity and findings at gross necropsy were unremarkable. The result is a read across from tetradecanol (CAS 112-72-1).
- Executive summary:
Inhalation of vapours of long chained alcohols in the range C6-C22 at levels up to the saturated vapour pressure is unlikely to be associated with significant toxicity.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 10 males (250 g) and 10 females (200g) wistar rats
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- 7.4 mg/m3
- No. of animals per sex per dose:
- 10 males and 10 females rats
- Control animals:
- no
- Details on study design:
- single exposure of the whole body during 4 hours at the maximum saturated concentration. The animals were submitted to a two week observation period after exposure.
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- > 7.4 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: maximum saturated vapor concentration
- Mortality:
- none
- Clinical signs:
- other: none
- Body weight:
- no changes
- Gross pathology:
- no changes
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- N-heptanol is not toxic by inhalation.The rat 4 hour LC50 for 1-heptanol is > saturated vapour concentration.
- Executive summary:
The test item, n-heptanol-1 was exposed by inhalatation to 10 males and 10 females rats at the maximum saturated concentration via asingle whole body inhlation exposure during 4 hours. Animals were submitted to a 2 week observation period. No mortality was recorded in any animal. No signs of narcosis were observed nor abnormal behaviour. The histopathological examination of the sample organs (brain, lung, heart, liver, pancreas, bladder, kidneys, ovaries and testes) has revealed no treatement related changes. At the maximum vapour saturated concentration, no mortality was recorded after a single exposure during 4 hours. The LC0 was estimated at 7.4 mg/m3.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: in house protocol
- GLP compliance:
- not specified
- Test type:
- other: screening test with concentrated vapours
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS: Rat (Sprague-Dawley)
- Source: not reported
- Weight at study initiation: not reported
- Number of animals: 6 M+F
- Controls: none - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: atmosphere of warmed concentrated vapours
- Details on inhalation exposure:
- ADMINISTRATION:
-6 hour vapour exposure, whole body
- Type of exposure: vapour inhalation
- Concentrations: reported as a concentrated vapour only
- Particle size: vapour
- Type or preparation of particles: Vapour generated by by passing a stream of warm air over the material (at the melting point temperature).
EXAMINATIONS: Mortality was recorded during the 6 hour exposure and subsequent 14 day observation period. All animalswere subjected to gross necropsy at the end of the observation period. - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 6 h
- Concentrations:
- Concentrations: reported as a concentrated vapour only
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- EXAMINATIONS: Mortality was recorded during the 6 hour exposure and subsequent 14 day observation period. All animalswere subjected to gross necropsy at the end of the observation period.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.012 ppm
- Based on:
- test mat.
- Exp. duration:
- 6 h
- Remarks on result:
- other: Data calculated from the saturated vapour pressure; substantially saturated atmospheric concentration)
- Mortality:
- All rats survived the exposure period and subsequent 14 day observation period.
- Clinical signs:
- other: Not reported.
- Body weight:
- No effects.
- Gross pathology:
- No significant gross abnormalities were seen at autopsy.
- Other findings:
- NECROPSY FINDINGS: Unremarkable other than slight pulmonary congestion.
POTENTIAL TARGET ORGANS: Possible effect on the lungs.
SEX-SPECIFIC DIFFERENCES: None reported - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- This rat screening test indicates that a 6 hour inhalation exposure to the concentrated vapours of Alcohols, C16-18 is not toxic. Gross necrospy revealed slight pulmonary congestion. LC50 expected to be > 0.012 ppm (substantially saturated atmospheric concentration).
The rat 6 hour LC50 for Alcohols, C16-18 is > saturated vapour concentration. - Executive summary:
Inhalation of vapours of Alcohols, C16-18 at levels up to the saturated vapour pressure is unlikely to be associated with significant toxicity. The LC50 values exceeded the maximum achievable vapour concentrations and showed no evidence of toxicity after a single exposure for 6 hours
Referenceopen allclose all
To convert mg/m3 into ppm at 25°C and 760 mm Hg (101.32 kPa)
ppm = mg/m3 x 24.45
molecular weight
To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa)
mg/m3 =ppm x molecular weight
24.45
mg/m3 =4.9x 200 =40.08
24.45
To convert mg/l into mg/m³
1 mg/m³=mg/l x 1000,
21mg/lx1000=21000 mg/m³
To convert mg/m3 into ppm at 25°C and 760 mm Hg (101.32 kPa)
ppm = mg/m3 x 24.45
molecular weight
21000 x (24.45/102.18)=5025 ppm
To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa)
mg/m3 =ppm x molecular weight
24.45
mg/m3 =5025x 102.18 =21000
24.45
To convert mg/l into mg/m³
1 mg/m³=mg/l x 1000,
21mg/lx1000=21000 mg/m³
To convert mg/m3 into ppm at 25°C and 760 mm Hg (101.32 kPa)
ppm = mg/m3 x 24.45
molecular weight
21000 x (24.45/102.18)=5025 ppm
To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa)
mg/m3 =ppm x molecular weight
24.45
mg/m3 =5025x 102.18 =21000
24.45
Table 1: Concentrations, exposure conditions and number of evident toxicity per animals treated
Nominal Conc. (mg/L) |
MMAD µm |
GSD
|
Number with evident toxicity (#/total) |
||
Males |
Females |
Combined |
|||
1.5mg/L |
|
|
0 /5 |
0/5 |
0/10 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 40.08 mg/m³ air
- Quality of whole database:
- LC50 of Alcohols, C12-14 expected to be > 4.9 ppm (substantially saturated atmospheric concentration). To convert ppm into mg/m3 at 25°C and 760 mm Hg (101.32 kPa) mg/m3 =ppm x molecular weight /24.45. mg/m3 =4.9x 200/24.45=40.08 mg/m3
The 4 hour rat inhalational LC50 for Alcohols, C12-14 is >saturated vapour concentration. There were no signs of toxicity during exposure or the subsequent observation period..The rat 4 hour LC50 for Alcohols, C12-14 is > saturated vapour concentration.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: contract laboratory protocol
- GLP compliance:
- no
- Test type:
- other: LD50
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.2 to 3.1 kg
- Housing: Individual housing in metal cages which were elevated above the droppings.
- Diet: Purina Rabbit Chow (ad libitum)
- Water: tap water (ad libitum)
IN-LIFE DATES: Not specified. - Type of coverage:
- semiocclusive
- Vehicle:
- other: applied undiluted
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Skin of the trunk.
- Type of wrap if used: Plastic binder
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test material was washed from the animals' bodies which were then carefully blotted dry with absorbent paper hand towels.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): maximum dose 1-2 ml/kg, doses 1, 1.5 and 2 g/kg
VEHICLE
- Concentration (if solution): Applied undiluted. - Duration of exposure:
- 24 hours
- Doses:
- 1, 1.5 and 2 g/kg
- No. of animals per sex per dose:
- 2 male, 2 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed at the beginning and end of the study period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The animals were observed for gross effects at regular intervals on the day of dosing and daily thereafter for 14 days. - Statistics:
- No statistical analysis of the results was carried out.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Low toxicity expected; LD50 > 2000
- Mortality:
- All deaths occurred within 3 days of exposure. Number of deaths at each dose: Intact skin 0/2, 1/2 and 2/2, abraded skin 0/2, 0/2 and 2/2. LD50(s) were as follows: Intact skin: 1.5 g/kg; Abraded skin: 1.5 - 2 g/kg; combined intact and abraded 1.5 - 2 g/kg.
- Clinical signs:
- other: At the dose of 1g/kg there were no signs of toxicity. At higher dose levels some prostration was noted. Survivors appeared normal 72 hours after exposure. Animals at all dose levels showed erythema, wrinkling and desquamation of the application site.
- Gross pathology:
- In premature decedents there was some general deterioration but no dose-related lesions. Tissues of survivors sacrificed at the end of the observation period were unremarkable.
- Other findings:
- No potential target organs were identified. The results were reported in combined form with no note on sex specific differences.
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rabbit dermal LD50 of Alcohols, C12-14 was > 2000 mg/kg. All rabbits showed irritation of the application site immediately following exposure. Some prostration was observed in animals at the higher dose levels. Necropsy findings showed no treatment related lesions.
- Executive summary:
C12-14 alcohols are expected to be of low acute dermal toxicity LD50 >2000 mg/kg.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method other: screening test
One rabbit was exposed at each of 5 dose levels ranging from 1 to 10 g/kg. The treated area was covered with a plastic shield for an exposure period of 24 hours. The animals were then observed for 14 days. - GLP compliance:
- not specified
- Test type:
- other: screening test
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS: Rabbit (New Zealand White)
- Source: Not reported.
- Weight at study initiation: 2.3-3 kg
- Group size: 5 (sex unspecified
- Type of coverage:
- occlusive
- Vehicle:
- other: undiluted (heated to melting point)
- Details on dermal exposure:
- ADMINISTRATION: 24 hour occluded exposure
- Area covered: trunk of animal
- Occlusion: plastic sleeve
- Vehicle: undiluted (heated to melting point)
- Doses: 1, 2.5, 5, 7.5 and 10 g/kg
- Removal of test substance: not reported
EXAMINATIONS: Mortality, behaviour and weight gain were observed over the 14 day observation period. - Duration of exposure:
- 24 hour occluded exposure
- Doses:
- 1, 2.5, 5, 7.5 and 10 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- EXAMINATIONS: Mortality, behaviour and weight gain were observed over the 14 day observation period.
One rabbit was exposed at each of 5 dose levels ranging from 1 to 10 g/kg. The treated area was covered with a plastic shield for an exposure period of 24 hours. The animals were then observed for 14 days. - Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the exposure and observation period.
- Clinical signs:
- other: None reported.
- Gross pathology:
- Not carried out.
- Other findings:
- POTENTIAL TARGET ORGANS: None identified
SEX-SPECIFIC DIFFERENCES: Sex not specified. - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rabbit dermal LD50 (24 hour occluded) for Alcohols, C16-18 was >10000 mg/kg . There were no deaths or reports of toxicity.
- Executive summary:
All 5 animals survived. The LD50 was found to be greater than 10,000 mg/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: contract laboratory protocol
- GLP compliance:
- no
- Test type:
- other: LD50
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.2 to 3.1 kg
- Housing: Individual housing in metal cages which were elevated above the droppings.
- Diet: Purina Rabbit Chow (ad libitum)
- Water: tap water (ad libitum)
IN-LIFE DATES: Not specified. - Type of coverage:
- semiocclusive
- Vehicle:
- other: applied undiluted
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Skin of the trunk.
- Type of wrap if used: Plastic binder
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test material was washed from the animals' bodies which were then carefully blotted dry with absorbent paper hand towels.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): maximum dose 1-2 ml/kg, doses 1, 1.5 and 2 g/kg
VEHICLE
- Concentration (if solution): Applied undiluted. - Duration of exposure:
- 24 hours
- Doses:
- 1, 1.5 and 2 g/kg
- No. of animals per sex per dose:
- 2 male, 2 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed at the beginning and end of the study period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The animals were observed for gross effects at regular intervals on the day of dosing and daily thereafter for 14 days. - Statistics:
- No statistical analysis of the results was carried out.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 1 500 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All deaths occurred within 3 days of exposure. Number of deaths at each dose: Intact skin 0/2, 1/2 and 2/2, abraded skin 0/2, 0/2 and 2/2. LD50(s) were as follows: Intact skin: 1.5 g/kg; Abraded skin: 1.5 - 2 g/kg; combined intact and abraded 1.5 - 2 g/kg.
- Clinical signs:
- other: At the dose of 1g/kg there were no signs of toxicity. At higher dose levels some prostration was noted. Survivors appeared normal 72 hours after exposure. Animals at all dose levels showed erythema, wrinkling and desquamation of the application site.
- Gross pathology:
- In premature decedents there was some general deterioration but no dose-related lesions. Tissues of survivors sacrificed at the end of the observation period were unremarkable.
- Other findings:
- No potential target organs were identified. The results were reported in combined form with no note on sex specific differences.
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rabbit dermal LD50 of Alfol 12 was between 1500 and 2000 mg/kg. All rabbits showed irritation of the application site immediately following exposure. Some prostration was observed in animals at the higher dose levels. Necropsy findings showed no treatment related lesions.
Dodecan-1-ol (C12) is supporting substance for Alcohols,C12-C14 and the main component. - Endpoint:
- acute toxicity: dermal
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Method: other: contract laboratory protocol
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.28-3.05 kg
- Housing: individual housing in metal cages
- Diet: ad libitum
- Water: ad libitum - Type of coverage:
- other: occlusive; intact and abraded skin
- Vehicle:
- other: undiluted
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the trunk
- Type of wrap if used: A plastic binder was slipped onto each animal and by means of a syringe, undiluted test material was introduced under the binder and spread evenly over the skin of the treatment site. The binder was then fastened tightly to keep the preparation in close contact with the skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess material was washed away and the area dried with absorbent paper towels. An estimate was made of the the
amount of unabsorbed material.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Total volume applied: maximum dose 11-12 ml/kg - Duration of exposure:
- 24 hours
- Doses:
- 0.5, 1, 2, 4, 6, 8 and 12 g/kg
- No. of animals per sex per dose:
- 4 (2 with intact skin, 2 with abraded)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for gross effects at regular intervals on the day of dosing and daily thereafter for 14 days. Body weights were recorded prior to dosing and on observation day 14.
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 8 000 - <= 12 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All deaths occurred between days 2 and 10 after administration. Number of deaths at each dose: Intact skin 0/2, 0/2, 2/2, 1/2, 1/2, abraded skin 0/2, 1/2, 0/2,0/2, 1/2, 1/2. Combined 0/4, 1/4, 2/4, 1/4, 2/4, 2/4. It appeared that most of the test substance was absorbed. The LD50 for combined abraded and intact skin was considered to be between 8 and 12 g/kg. The small group size and erratic dose response precluded separate estimation for intact and abraded skin.
- Clinical signs:
- other: At the end of the exposure period all animals showed slight to moderate erythema at the application site. In all survivors wrinkling and/or coreaceousness, hardening and desquamation of the skin occurred and persisted in varying degrees until the end of t
- Gross pathology:
- Animals which died showed one or more of the following: depletion of visceral fatty tissue, moderate accumulation of clear fluid within the peritoneal cavity, moderate congestion of lungs and kidneys, haemorrhaging and/or blanching with erosion of the gastric mucosa. Rabbits surviving to 14 days showed slight to moderate accumulation of clear viscous liquid within the peritoneal cavity and/or depletion of visceral fatty tissues. 9/16 rabbits showed no gross systemic changes.
- Other findings:
- - Potential target organs: gastric mucosa
- Other observations: More females than males succumbed to the effects of the test material. - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rat dermal LD50 for this sample of Alfol 12 was in the range of 8000-12000 mg/kg (24 occluded exposure). All test animals developed skin irritation at the application site persisting throughout the observation period. Clinical signs of toxicity were generalised weakness and unthriftiness. Haemorrhage and/or blanching with erosion of the gastric mucosa was reported in premature decedents but not in rabbits which survived to the end of the exposure period.
Dodecan-1-ol (C12) is supporting substance for Alcohols,C12-C14 and the main component. - Endpoint:
- acute toxicity: dermal
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: other: Contract laboratory protocol
- GLP compliance:
- not specified
- Test type:
- other: LD50
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.3 to 2.9 kg
- Housing: The rabbits were individually housed in metal cages elevated above the droppings.
- Diet: Purina rabbit Chow (ad libitum)
- Water: Tap water (ad libitum)
IN-LIFE DATES: Not stated - Type of coverage:
- occlusive
- Vehicle:
- other: 50% w/w dilution tetradecanol in 1 % w/w gum tragacanth
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The skin of the trunk which was clipped free of hair.
- Type of wrap if used: plastic binder
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The binder was removed and the amount of unabsorbed substance estimated. The animals were then washed and the carefully blotted dry with absorbent hand towels.
- Time after start of exposure: The test compound was removed after 24 hours of exposure.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The animals were distributed evenly as to sex in each of three dosage groups as follows: 2M+2F (1M+1F each intact and abraded) and dosed 2.0, 4.0 and 8.0 g/kg of the test substance.
- Concentration (if solution): A 50% w/w dilution of ALFOL 14 alcohol in 1% w/w gum tragacanth.
VEHICLE
- Amount(s) applied (volume or weight with unit): 1% w/w gum tragacanth. - Duration of exposure:
- 24 hours
- Doses:
- 2, 4 and 8 g/kg
- No. of animals per sex per dose:
- 2
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for gross effects at regular intervals on the day of dosing and daily thereafter for fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Body weights were recorded prior to dosing and on observation day 14. - Statistics:
- No statistical analysis was carried out
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 8 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 100% of the animals with abraded skin died between 8 and 10 days of the exposure period. The animals with intact skin survived.
- Clinical signs:
- other: At twenty-four hours following test application, all animals showed slight to moderate erythema, desquamation, wrinkling and dryness of the skin at the treatment site. In all surviving animals, desquamation and wrinkling of the skin occurred and persisted
- Gross pathology:
- Gross necropsy of animals which succumbed showed depletion of visceral fatty tissue (one animal), moderate dermal irritation and desquamation at the treatment site (two animals). Gross necropsy of the animals which survived the 14 day observation period and were sacrificed, showed one animal with slight accumulation of clear viscous fluid within the peritoneal cavity and crazing over cortex of both kidneys. Eight animals showed no signs of gross systemic abnormalities.
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rabbit dermal LD50 (24 hour occluded) for Alfol 14 was approx. 8000 mg/kg. All survivors showed skin irritation at the application site throughout the observation period. Signs of intoxication included weakness, emaciation and pallor.Tetradecanol (C14) ) is supporting substance for Alcohols,C12-C14 and the one of the component in Alcohols,C12-C14 .
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: published data
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Method: other: Contract laboratory protocol
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS: Rabbit (New Zealand White)
- Source: Not reported.
- Weight at study initiation: 2.3-3 kg
- Group size: 4 (sex unspecified
- Controls: no - Type of coverage:
- occlusive
- Vehicle:
- peanut oil
- Details on dermal exposure:
- ADMINISTRATION: 24 hour occluded exposure
- Area covered: trunk of animal
- Occlusion: plastic sleeve
- Vehicle: peanut oil
- Concentration in vehicle: 50%
- Doses: 8000 g/kg
- Removal of test substance: not reported
EXAMINATIONS: Mortality, behaviour and weight gain were observed over the 14 day observation period. - Duration of exposure:
- 24 hour occluded exposure
- Doses:
- 8 g/kg as 50% in vehicle
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- EXAMINATIONS: Mortality, behaviour and weight gain were observed over the 14 day observation period.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 8 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the exposure and observation period.
- Clinical signs:
- other: None reported.
- Gross pathology:
- Not carried out.
- Other findings:
- POTENTIAL TARGET ORGANS: None identified
SEX-SPECIFIC DIFFERENCES: Sex not specified. - Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The rabbit dermal LD50 (24 hour occluded) for Alcohols, C16-18 was >8000 mg/kg applied as a 50% solution in peanut oil. There were no deaths or reports of toxicity.
- Executive summary:
The rabbit dermal LD50 (24 hour occluded) for Alcohols, C16-18 was >8000 mg/kg applied as a 50% solution in peanut oil. There were no deaths or reports of toxicity.
Referenceopen allclose all
Table 1: Number of animals with intact skin dead and the time range within which mortality occurred.
Dose |
Mortality (# dead/total) |
Time range of deaths (day) |
||
Male |
Female |
Combined |
||
1.0 |
|
|
0/2 |
|
1.5 |
|
|
1/2 |
3 |
2.0 |
|
|
2/2 |
8 |
Table 2: Number of animals with abraded skin dead and time range within which mortality occurred.
Dose |
Mortality (# dead/total) |
Time range of deaths (day) |
||
Male |
Female |
Combined |
||
1.0 |
|
|
0/2 |
|
1.5 |
|
|
0/2 |
2 and 5 |
2.0 |
|
|
2/2 |
|
Table 1: Number of animals dead within the 14 day observation period.
Dose |
Mortality (# dead/total) |
Time range of deaths (day) |
||
Male |
Female |
Combined |
||
2.0 |
0/2 |
0/2 |
0/4 |
- |
4.0 |
0/2 |
0/2 |
0/4 |
- |
8.0 |
1/2 |
1/2 |
2/4 * |
9 and 11 |
*thedead animals were from the group with skin prepared with abrasion.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity
Alcohols, C12-14 is from the category of Long Chain aliphatic Alcohols within a carbon chain length range of C6-C22. The acute oral LD50 in male/female rats is >10000 mg/kg bw . No significant gross abnormalities were seen at autopsy. )). This show that Alcohols, C12-14 is practically nontoxic for acute oral toxicity. Alcohols, C12-14 was not classified according to EU or GHS criteria.
Considering the data for linear alcohols in the range 1-octanol to 1-docosanol and including unsaturated alcohols, the oral LD50values range from > 5000 mg/kg to well over 10,000 mg/kg, with most of values representing the maximum administered dose.
Clinical Signs. Few, if any signs of toxicity were reported following oral administration of the linear alcohols ranging from C6 to C22 alcohols. At doses approaching acute lethality loss of appetite, lethargy and diarrhoea was reported for most members of the linear alcohols. Animals surviving a large oral dose showed no evidence of any delayed or irreversible effects following acute administration of any of these alcohols. In decedents irritation of the gastro-intestinal tract and typical agonal changes were observed, however no substance specific observations could be recognised for any of the materials of this sub-category. There are no observations reported to suggest a potential for CNS depression following administration of a single oral dose of a linear alcohol within this category.
Conclusion:The category of the long chained aliphatic alcohols (linear and essentially linear) is of a low order of acute toxicity upon oral administration.Alcohols, C12-14 was not classified according to EU or GHS criteria.
Acute inhalation toxicity
Alcohols, C12-14 is from the category of Long Chain aliphatic Alcohols within a carbon chain length range of C6-C22.
The 4 hour rat inhalational LC50 for Alcohols, C12-14 is >saturated vapour concentration. There were no signs of toxicity during exposure or the subsequent observation period..The rat 4 hour LC50 for Alcohols, C12-14 is > saturated vapour concentration.
Results indicate that Alcohols, C12-14 is not toxic for acute inhalation toxicity. Alcohols, C12-14 was not classified according to EU or GHS criteria.
The available data cover the lower (1-hexanol and 1-octanol), intermediate (1-decanol, 1-dodecanol) and higher (1-tetradecanol, C16-18alcohols) chain-lengths of the linear alcohols subcategory.
The volatility of the category of aliphatic alcohols as a whole is low. Saturated vapour pressures for the higher chain alcohols are extremely low; for example the calculated concentration of a saturated atmosphere of 1-dodecanol and 1-octadecanol at ambient conditions is in the order of 10-2and 10-5mg/L, respectively. Most experimental studies used the maximum achievable vapour concentrations or aerosols for the assessment of the acute lethal concentration. For all substances tested the LC50 values exceeded the maximum achievable vapour concentrations. Even the more volatile members of this category (e.g. 1-hexanol, C6-12 essentially linear alcohols [Types B and C], 1-heptanol and 1-undecanol) showed no evidence of toxicity after a single exposure for 1 – 6 hours
None of the acute inhalation studies provided any evidence of a potential for CNS depression for the category of aliphatic alcohols. This conclusion is further supported by data in mice indicating that inhalation of high concentrations (up toca. 10,000 ppm) of 1-heptanol for short periods of time did not induce anaesthesia.
Conclusion: Inhalation of vapours of long chained alcohols in the range C6-C22 at levels up to the saturated vapour pressure is unlikely to be associated with significant toxicity.Alcohols, C12-14 was not classified according to EU or GHS criteria.
Acute Dermal Toxicity
Alcohols, C12-14 is from the category of Long Chain aliphatic Alcoholswithin a carbon chain length range of C6-C22.
For the linear alcohols in the range, C6 - C10 most of the reported LD50 values in rabbits are in the range 2000 - 4000 mg/kg.
The rabbit dermal LD50 of Alcohols, C12-14 was > 2000 mg/kg. This show that Alcohols, C12-14 is not toxic for acute Dermal toxicity . Alcohols, C12-14 was not classified according to EU or GHS criteria
For the alcohols C12 and higher the acute dermal LD50 values were 8000 mg/kg or higher. Although some incidental LD50 values below 2000 mg/kg were reported, these values generally represented the maximum dose tested. Substances with a chain length beyond C18 have not been tested but on the basis of the consistent low acute dermal toxicity for alcohols with a chain-length of C16 and below and the consistently low oral acute toxicity for the category as a whole it is expected that aliphatic alcohols in the range C18 – C22 are of a low order of acute dermal toxicity.
Clinical signs.Occluded exposure for 24 hours generally caused local dermal irritation. There was a clear (inverse) relationship between the chain length and the severity of the dermal effects. The severity of the irritation was graded as moderate – severe for the lower members of this category; typical observations included erythema, oedema, wrinkling, desquamation and cracking. The grading of the local effects for the aliphatic alcohols with a longer carbon chain was reported as slight-moderate. Animals showing signs of significant local irritation displayed signs of toxicity such as general weakness, anorexia, lethargy; it is not possible to ascertain if these findings were secondary to the irritation or evidence of direct systemic toxicity.
Conclusion:The category of the long chained aliphatic alcohols is of a low order of acute toxicity upon dermal administration. Alcohols, C12-14 was not classified according to EU or GHS criteria.
Justification for classification or non-classification
Based on the hazard assessment of Alcohols, C12-14 in section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99)and according to the criteria described in Directive 67/548 and in the CLP Regulation:
Directive 67/548 |
Very Toxic (T+) R28: Very toxic if swallowed R27: Very toxic in contact with skin R26: Very toxic by inhalation R39/26 R39/27 R39/28: Dangerous of very serious irreversible effects Toxic (T): R25: Toxic if swallowed R24: Toxic in contact with skin R23: Toxic by inhalation R39/23 R39/24 R39/25: Danger of very serious irreversible effects Harmful (Xn): R22: Harmful if swallowed R21: Harmful in contact with skin R20: Harmful by inhalation R65: Harmful may cause lung damage if swallowed R21/22 Harmful; Harmful in contact with skin and if swallowed. R68/20 R68/21 R68/22: Possible risk of irreversible effects Other toxicological properties R67: Vapours may cause drowsiness and dizziness |
CLP |
H300 Acute Tox. 2 Fatal if swallowed H310 Acute Tox. 1 Fatal in contact with skin H330 Acute Tox. 2 Fatal if inhaled H370 STOT SE 1 H301 Acute Tox. 3 Toxic if swallowed H311 Acute Tox. 3 Toxic in contact with skin H331 Acute Tox. 3 Toxic if inhaled H370 STOT SE 1 H302 Acute Tox. 4 Harmful if swallowed H312 Acute Tox. 4 Harmful in contact with skin H332 Acute Tox. 4 Harmful if inhaled H304 Asp. Tox. 1 H371 STOT SE 2 (May cause damage to organs (or state all organsaffected if known) (state route of exposure if it is conclusively proventhat no other routes of exposure cause the hazard) Other toxicological properties H336 STOT SE 3 May cause drowsiness or dizziness
|
It is concluded that the substance Alcohols, C12-14 does not meet the criteria to be classified for human health hazards for acute oral effects
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