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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, analogue approach)
Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, analogue approach)
Acute toxicity: Inhalation LC50 (rat, m/f): > 5.0 mg/L air (OECD 403, analogue approach)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common origin, common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to endpoint discussion for further details).
Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common origin, common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to endpoint discussion for further details).
Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 05 Jan - 19 Jan 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD) (limited data on test substance).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- limited data on test substance
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- limited data on test substance
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Safepharm laboratories ltd., Derby, UK
- 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 River, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males: 202 - 217 g (male) and 202 - 212 g (female)
- Housing: individually housed in suspended polypropylene cages for the time of exposure and in groups of five, by sex, for the reminder of the study.
- Diet: ad libitum, Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, UK
- Water: ad libitum
- Acclimation period: minimum 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 (18 at one ocasion, this was not considered relevant for the study)
- Humidity (%): 47-67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: approx. 10% of total body surface
- Type of wrap if used: gauze secured with self adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with cotton wool moistened with distilled water
- Time after start of exposure: 24 h - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5 h; 1 h; 2 h and 4 h after dosing and daily thereafter for 14 days. Weighing on Days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Skin reactions according to Draize Scoring System (1977) - Statistics:
- Not required
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate, reliable study (Klimisch score 2 due to read-across) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common origin, common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to endpoint discussion for further details).
Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Additional information
Justification for grouping of substances and read-across
There are no data available for the acute toxicity of Fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1). In order to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Overview for acute toxicity
CAS |
Acute toxicity oral |
Acute toxicity inhalation |
Acute toxicity dermal |
70983-72-1 (a) Target substance |
RA: CAS 68424-31-7 RA: CAS 84418-63-3 RA: CAS 146289-36-3 |
RA: CAS 68424-31-7 RA: CAS 85536-35-2 |
RA: CAS 131459-39-7 |
84418-63-3 (b) |
LD50 > 2000 mg/kg bw |
-- |
-- |
68424-31-7 |
LD50 > 2000 mg/kg bw |
LD50 > 5.1 mg/L air |
-- |
131459-39-7 |
-- |
-- |
LD50 > 2000 mg/kg bw |
146289-36-3 |
LD50 > 2000 mg/kg bw |
-- |
-- |
85536-35-2 |
-- |
LD50 > 5 mg/L air |
-- |
(b) Substances that are either already registered under REACh or not subject to the REACh Phase-in registration deadline of 31 May 2013 are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.
The above mentioned substances are considered to be similar on the basis of the structural and similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).Discussion
Acute oral toxicity
Acute toxicology: oral
Since no studies investigating the acute oral toxicity of Fatty acids C5-10 esters with dipentaerythritol (CAS 70983-72-1) are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across from the structurally related analogue substances Fatty acids, C5-10, esters with pentaerythritol (CAS# 68424-31-7), isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS# 84418-63-3) and Pentaerythritol ester of pentanoic acids and isononanoic acid (CAS# 146289-36-3).
CAS 68424-31-7
For Fatty acids, C5-10, esters with pentaerythritol (CAS# 68424-31-7), an acute oral toxicity study (limit test) according to OECD TG 401 (Robinson, 1991) is available. Groups of 2 male and female Alderley Park SPF albino rats received a dose of 2000 mg /kg bw of test substance in corn oil by gavage. No mortality, signs of systemic toxicity and abnormalities during gross necropsy were observed. Initial loss of weight (due to predose fasting) was observed in treated animals. However, the animals gained a normal weight after dosing. Thus, the acute oral LD50 in rats was determined to be greater than 2000 mg/kg bw.
CAS 84418-63-3
An acute oral toxicity study (limit test) according to OECD TG 401 was conducted with isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS# 84418-63-3; McCall, 1991). Groups of 5 ALpk:AP male and female rats received a dose of 2000 mg /kg bw of test substance by gavage. The animals were observed for 8 days. No mortality and significant signs of systemic toxicity were seen during the observational period. All animals lost weight initially due the predose fasting but all had exceeded their initial body weight by Day 3 and weight gain continued until the end of the study. With regard to the gross pathology analysis a small number of abnormalities were observed. However these effects were considered as a spectrum of known background changes in this specific rat strain were considered to be not treatment related. Thus, the acute oral LD50 in rats was determined to be greater than 2000 mg/kg bw.
CAS 146289-36-3
In addition a limit test was conducted with Pentaerythritol ester of pentanoic acids and isononanoic acid (CAS# 146289-36-3) according to OECD 401 and under GLP conditions (Sterzel, 1991). 5 male and female Wistar rats were administered with 2000 mg/kg bw test substance in arachidis oil via gavage. No mortality occurred during the 14 day observation period. At the same time no clinical signs of toxicity and effect on body weight were observed up to the end of the observation period. Necropsy and histopathological examination revealed no substance-related findings. On the basis of the test results the LD50 was determined to be greater than 2000 mg/kg bw.
Acute toxicology: inhalation
Since no studies investigating the acute inhalation toxicity of Fatty acids C5-10 esters with dipentaerythritol (CAS# 70983-72-1) are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across from the structurally related substance fatty acids, C5-10, esters with pentaerythritol (CAS# 68424-31-7) and fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol (CAS# 85536-35-2) was conducted.
CAS 68424-31-7
An acute inhalation toxicity study (limit test) was performed with Fatty acids, C5-10, esters with pentaerythritol (CAS# 68424-31-7) according to OECD guideline 403 (Parr-Dobrzanski, 1994). Five rats per sex were exposed (nose only) to an aerosol of the test material with an analytical concentration of 5.10 mg/L air (nominal concentration was 5.0 mg/L air) for an exposure duration of four hours. No mortality occurred during the 14 day study period. Some clinical signs were noticed, which included hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for exposure. No effect on body weight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Thus, the LC50 after acute inhalation of Fatty acids, C5-10, esters with pentaerythritol (CAS# 68424-31-7) in male and female rats was found to be greater than 5.1 mg/L air.
CAS 85536-35-2
An acute inhalation toxicity study (limit test) was performed with Fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol (CAS# 85536-35-2) according to OECD guideline 403 (Parr-Dobrzanski, 1994). Five rats per sex were exposed (nose only) for four hours to an aerosol of the test material with an analytical concentration of 5.0 mg/L air. No mortality occurred during the 14 day study period. Clinical signs were seen during and/or immediately after exposure were hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur. In general, animals showed a rapid recovery from these effects by Day 2, although, hunched posture and piloerection persisted in few animals to Days 4 and 8, respectively. No effect on body weight was noted. Finally necropsy and histopathological examination revealed no substance-related findings. Thus, the LC50 after acute inhalation of Fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol in male and female rats was found to be greater than 5.0 mg/L air.
Acute toxicology: dermal
Since no acute dermal toxicity studies with Fatty acids C5-10 esters with dipentaerythritol (CAS# 70983-72-1) are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across from the structurally related analogue substances 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS# 131459-39-7).
CAS 131459-39-7
The acute dermal toxicity potential 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS #131459-39-7) was investigated in limit test performed according to OECD guideline 402 (Allen, 1999) and under GLP conditions. The back and flanks regions of five male and female Sprague-Dawley rats were treated with 2000 mg/kg bw test material under semiocclusive conditions. 24 hours after the dosing the treated area of skin was cleaned with distilled water and cotton wool. No mortality occurred and no clinical signs of toxicity were observed in any of the animals during the 14-day observation period. Necropsy and histopathological examination revealed no substance-related findings. The test substance had no effect on body weight.
Thus, the dermal LD50 after treatment with 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid in male and female rats was found to be greater than 2000 mg/kg bw.
Conclusion for acute toxicity
In summary, studies available from source substances Fatty acids, C5-10, esters with pentaerythritol (CAS# 68424-31-7), Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol (CAS 84418-63-3) and pentaerythritol ester of pentanoic acids and isononanoic acid (CAS# 146289-36-3) results in oral LD50 greater than 2000 mg/kg bw. For acute inhalation toxicity, two studies are available for substances Fatty acids, C5-10, esters with pentaerythritol (CAS# 68424-31-7) and fatty acids, C5-9, mixed esters with dipentaerythritol and pentaerythritol (CAS# 85536-35-2). From these studies a LC50 value for male rats and female rat greater than 5.0 mg/L air was evaluated. An acute dermal toxicity study conducted with 3,5,5-trimethylhexanoic acid mixed tetraesters with pentaerythritol and valeric acid (CAS# 131459-39-7) showed no effects at the limit dose 2000 mg/kg bw.
Thus, the available data indicate a very low level of acute toxicity for the all the source substance and thus no hazard for acute oral, inhalation and dermal toxicity was identified.
Justification for selection of acute toxicity – oral endpoint
Hazard assessment is conducted by means of read-across from structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).
Justification for selection of acute toxicity – inhalation endpoint
Hazard assessment is conducted means of read-across based on structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).
Justification for selection of acute toxicity – dermal endpoint
Hazard assessment is conducted by means of read-across from a structural analogue. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Justification for classification or non-classification
Based on read-across from structurally similar substances, the available data on oral, inhalation and dermal toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.