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Diss Factsheets
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EC number: 701-175-2 | 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Amines, C10-C14-tert-alkyl
- EC Number:
- 701-175-2
- Cas Number:
- 68955-53-3
- Molecular formula:
- C10H23N to C14H31N
- IUPAC Name:
- Amines, C10-C14-tert-alkyl
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River-Kingston, Stone Ridge, New York
- Age at study initiation: approximately 55 days old (males); approximately 65 days old (females)
- Weight at study initiation: 223 to 248 g (males); 206 to 243 g (females)
- Fasting period before study: not reported
- Housing: one/cage in suspended stainless steel cages
- Diet (e.g. ad libitum): Purina certified rodent chow 5002(C)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 24 degrees C
- Humidity (%): 41 to 46%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
IN-LIFE DATES: From: July 21, 1992 To: August 4, 1992
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Neutral Oil 100 N
- Details on dermal exposure:
- TEST SITE
- Area of exposure: entire trunk between the flank and shoulders- approximatelly 6 x 6 cm
- % coverage: not reported
- Type of wrap if used: polyethylene sheet covered with Elastoplast (Beiersdorf, Inc. Norwalk, Connecticut) and PEG (Becton-Dickinson Co. Franklin Lakes, New Jersey) elastic bandages secured in place with adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours, the backs were wiped with water-soaked paper towels.
- Time after start of exposure: after 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 mL/kg
- Concentration (if solution): none
- Constant volume or concentration used: yes
- For solids, paste formed: not appicable
VEHICLE Neutral Oil 100 N- contains 100% of refined paraffinic distillate
- Amount(s) applied (volume or weight with unit): 2.0 mL/kg
- Concentration (if solution): none
- Lot/batch no. (if required): 8-0419
- Purity: no data - Duration of exposure:
- 24 hour
- Doses:
- 50, 200, and 400 mg/kg
- No. of animals per sex per dose:
- 36
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs observed 0.5, 1, 2, and 4 hr after dosing and once daily for 14 days. Body weights recorded on day 0 (prior to dosing) and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- The mortality incidences of males and females were compared across doses with a categorical data modelling procedure using SAS CATMOD (SAS Institute, Inc. SAS User's Guide: Statistics, Version 5 Edition, p 171-253. Cary, NC: SAS Institute Inc., 1985). The criterion of statistical significance was 0.05. If the results indicate a significant difference between the mortality responses for males and females, the LD50 is calculated separately by sex; otherwise the LD50 is calculated on the pooled mortality incidences at each dose.
The LD50, 95% confidence limits, and slope were calculated from the logarithm of the doses and the incidences of mortality using a SAS PROBIT procedure (SAS Institute, Inc. SAS User's Guide: Statistics, Version 5 Edition, p 171-253. Cary, NC: SAS Institute Inc., 1985) based on the method of D.J. Finney (Probit Analysis, Third Edition, London: Cambridge University Press, 1971).
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 251 mg/kg bw
- 95% CL:
- > 190 - < 322
- Mortality:
- - Time of death: Males - 1 at 200 mg/kg 4 hr post-dosing (day 0); 3 at 400 mg/kg 2 hr post-dosing (day 0); 3 at 400 mg/kg 4 hr post-dosing (day 0). Females - 1 at 200 mg/kg 4 hr post-dosing (day 0); 1 at 200 mg/kg on day 1; 5 at 400 mg/kg 4 hr post-dosing (day 0). A dose-related increase in mortality was observed in the 200- and 400-m/kg dose groups.
- Number of deaths at each dose: (number of deaths/number treated)
Dose (mg/kg) 50 200 400
Males 0/6 1/6 6/6
Females 0/6 2/6 5/6 - Clinical signs:
- other: No mortalities and no clinical signs related to the test substance were seen in the 50- mg/kg dose group. Clinical signs indicative of neurotoxicity (tremors and/or convulsions) were observed in survivors as well as decedents in the 200- and 400-mg/kg do
- Gross pathology:
- Necropsy of the decedents revealed numerous skin irritation effects related to the test substance. No gross changes observed in survivors.
- Other findings:
- - Potential target organs: skin
- Other observations: no statistically significant sex-related differences
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Executive summary:
The dermal toxicity of the test material was evaluated in Crl:CD BR rats. The test material was dispersed in neutral oil and applied topically to the shaved intact skin of three groups of rats (6/sex/group) at 50, 200 or 400 mg/kg (2 ml/kg) body weight. The application sittes were occluded for 24 hr. After the 24 -hr exposure, the application sites were washed with tap water. No mortalities and no clinical signs related to the test substance were seen in the 50 mg/kg dose group. A dose-related increase in mortality was observed in the 200 and 400 mg/kg dose groups. Clinnical signs indicative of neurotoxicity (tremors and/or convulsions) were observed in survivors as well as decedents in the 200 and 400 mg/kg dose groups. Surviving animals recovered from the neurotoxic effects in this study. There was no apparent test substance related body weight effects in thsi study. Numerous skin irritation effects were seen in both sexes at all doses. No treatment related signs were seen at necropsy (other than skin irritaion). The overall no observed effect level (NOEL) was 50 mg/kg.
Sincec no statistically significant sex-related difference in mortality was observed, the LD50 was calculated from the combined mortality incidence data. The acute dermal LD50 in male and female rats (combined) was 251 mg/kg with 95% confidence limits of 190 and 322 mg/kg.
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