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EC number: 251-136-4 | CAS number: 32647-67-9
- 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 Oral Toxicity:
The study was performed to assess the acute oral toxicity of the test item (EC 251-136-4) in the Wistar strain rat.
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity.
Body Weight. All animals showed expected gains in body weight.
Necropsy. No abnormalities were noted at necropsy.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System-Unclassified).
Acute Dermal Toxicity:
The acute dermal toxicity of the substance (EC 251-136-4) has been assessed by reading across the results of studies conducted on two structurally similar analogue substances, which are detailed below.
Source Substance; Gel All DX (EC-413 -110 -2):
A study was performed to assess the acute dermal toxicity of the test material (EC 413-110-2) in the Sprague-Dawley CD strain rat.
A group of 10 animals (5 males and 5 females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study.
All animals showed an expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bodyweight.
Source Substance; Gel All MD (EC 402-950-5):
The purpose of the study is to determine the acute dermal toxicity of technical GEL-ALL-MD (EC 402-950-5) to the rat.
Groups of 5 male and 5 female Sprague-Dawley rats received a single, 24 hour occluded, topical application of 2100 mg Technical Gel-ALL-MD/kg bodyweight, moistened with 0.5% w/v sodium carboxymethylcellulose in distilled water. A further 5 male and 5 female control animals were treated similarly except that no test material was applied to the skin. Animals were observed for 14 days after treatment and then examined post mortem.
There were no mortalities, no treatment-related clinical signs and no evidence of skin irritation. No treatment-related effects on bodyweight were recorded and no abnormalities were seen post-mortem.
In both sexes the acute dermal LD50 was greater than 2100 mg/kg bw.
Acute inhalation toxicity:
Study waived for target substance (EC 251-136-4).
An acute inhalation study conducted on source substance EC 402-950-5 gave an LC50 (4 hr) >0.67 mg/L air, the maximum attainable concentration.
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
- Study period:
- Experimental start date: 13 March 2017. Experimental completion date: 29 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- Identification: Geniset D
Batch: 5434
Purity: 99.4%
Physical state/Appearance: white powder
Expiry Date: 31 October 2018
Storage Conditions: room temperature in the dark - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animal Information
Female Wistar (RccHan™:WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20% of the mean body weight at the start of treatment.
Animal Care and Husbandry
The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon,
UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study. - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- Test Item Preparation and Analysis:
For the purpose of the study the test item was freshly prepared, as required, as a suspension in arachis oil BP. Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.
The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females at 2000 mg/kg
- Control animals:
- no
- Details on study design:
- Using available information on the toxicity of the test item, 2000 mg/kg was chosen as the starting dose.
In the absence of toxicity at a dose level of 2000 mg/kg (single female), an additional group of animals was treated at 2000 mg/kg.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose group to confirm the survival of the previously dosed animals.
Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays.
Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and
opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- No abnormalities were noted at necropsy
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
- Executive summary:
Introduction
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat.
Methods
Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
Results
Mortality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity.
Body Weight. All animals showed expected gains in body weight.
Necropsy. No abnormalities were noted at necropsy.
Conclusion
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System-Unclassified).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 October 1997 to 16 October 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: males: 215 to 243 g; females: 208 to 230 g
- Housing: animals were housed in suspended polypropylene cages furnished with wood flakes. The animals were housed individually during the 24-h exposure period and in groups of 5, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22 °C
- Humidity (%): 50 to 74 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/ 12
- On one occasion the relative humidity was above the limit specified in the protocol (70 %). This deviation was not considered to affect the purpose or integrity of the study. - Type of coverage:
- semiocclusive
- Vehicle:
- other: moistened with arachis oil BP.
- Details on dermal exposure:
- TEST SITE
- % coverage: 10 % of the total body surface
- Type of wrap if used: surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. The bandage was further secured with a piece of Blenderm wrapped around each end.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated skin and surrounding hair was wiped with cotton wool moistened with arachis oil BP to remoe any residual test material.
- Time after start of exposure: 24 h
TEST MATERIAL
- The test material, as received, was applied uniformly to an area of shorn skin which had been previously moistened with arachis oil BP. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5/ sex/ dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 h after dosing and subsequently once daily for 14 aysd. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: dermal reactions (scored according to the Draize scale). - 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 signs of systemic toxicity were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal reactions: No signs of skin irritation were noted.
- Interpretation of results:
- not classified
- Conclusions:
- The dermal toxicity of the test material was assessed according to OECD guideline 402. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the actue dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" and Method B3 of Commission Directive 92/69/EEC.
A group of 10 animals (5 males and 5 females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study.
All animals showed an expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bodyweight.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see Section 13 for "Read-across justification to support the REACH registration of Bis-O-(benzylidene)-D-glucitol (EC 251-136-4) at 10-100 tpa" for full details.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
It is proposed that the structural similarity and properties of the target substance and the structural analogue (sources substance) are sufficiently close for there to be a reasonable expectation of similar effects.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Soure substance:
IUPAC name: 1,3:2,4-bis-O-((3,4-dimethylphenyl)methylene) D-Glucitol
EC number: 413-110-2
CAS number: 135861-56-2
Target Substance: Bis-O-(benzylidene)-D-glucitol
IUPAC name: 1,3:2,4-bis-O-dibenzylidene-D-glucitol
EC number: 251-136-4
CAS number: 32647-67-9
3. ANALOGUE APPROACH JUSTIFICATION
Based on the structural similarity of the source substances and target substance, similarity of physic-chemical properties and similarity in experimental (eco)toxicological test data (and toxicokinetic behaviour assessment) it is concluded that target substance and the structural analogue (source substance) are sufficiently close for there to be a reasonable expectation of similar effects, for the endpoints where results have been read-across.
4. DATA MATRIX
Please see Section 13 for "Read-across justification to support the REACH registration of Bis-O-(benzylidene)-D-glucitol (EC 251-136-4) at 10-100 tpa" for full details. - Reason / purpose for cross-reference:
- read-across source
- 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 signs of systemic toxicity were noted during the study.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal reactions: No signs of skin irritation were noted.
- Interpretation of results:
- other: not classified under EU CLP
- Conclusions:
- The dermal toxicity of the test material was assessed according to OECD guideline 402. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the actue dermal toxicity of the test material (structural analogue source substance EC 413-110-2) in the Sprague-Dawley CD strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" and Method B3 of Commission Directive 92/69/EEC.
A group of 10 animals (5 males and 5 females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study.
All animals showed an expected gain in bodyweight during the study.
No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bodyweight.
It is proposed that this result can be used in the assessment of the target substance.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study conducted between April 1988 and June 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- other: modified procedure described by Noakes and Sanderson (similar to 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, Ltd, Manston Road, Margate, Kent
- Age at study initiation: Males were between 48 to 50 days old and females were between 56 to 65 days old
- Weight at study initiation: 278 g to 342 g for Males and 211 g to 267 g for Females
- Fasting period before study: not stated in report
- Housing: Rats were housed in pairs by sex and in steel mesh cages
- Diet (e.g. ad libitum): Free acess to Modified Expanded S.Q.C Rat and Mouse Diet No. 1
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 to 22 deg C
- Humidity (%): 44 to 54%
- Air changes (per hr): not stated in report
- Photoperiod (hrs dark / hrs light): 12 hours light followed by 12 hours of darkness
IN-LIFE DATES: From: Day of dosing (day 1) To: Day of sacrifice (day 14) - Type of coverage:
- occlusive
- Vehicle:
- other: moistened with 0.5% sodium carboxymethyl in distilled water.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 cm by 10 cm
- Type of wrap if used: aluminium foil (held in place by an encircling band of waterproof plaster).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated skin was washed with soap and water to remove residual test material and then rinsed with water and dried.
- Time after start of exposure: 24 hours
TEST MATERIAL
- For solids, paste formed: yes, test material was moistened with 0.5% w/v solution sodium carboxymethylcellulose in distilled water and applied to the shaved area at a dose level of 2100 mg/kg. - Duration of exposure:
- 24 hours
- Doses:
- 0 (control) and 2100 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females were tested at both the 0 and 2100 mg/kg dose range (e.g. 20 animals in total)
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs and behaviour frequently on the day of treatment, at least once each morning and afternoon on working days thereafter and at leaast once each other day. Bodyweights were recorded immediately prior to treatment on Day 1, on Day 8 and immediately prior to termination on Day 15.
- Necropsy of survivors performed: yes - all animals were killed by CO2 asphyxiation on Day 15 and subjected to gross post-mortem examination for external abnormalities and for abnormalities of the thoracic and abdominal viscera.
- Other examinations performed: skin irritation - after removal of the plaster, skin treatment sites were examined daily for evidence of skin irritation. - Statistics:
- The significance of difference between bodyweight change of control and test groups was estimated by the two sample test of Dunnett.
- Preliminary study:
- Range finding with 1 male and 1 female: no evidence of toxicity or skin irritation
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 100 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: There were no treatment related clinical signs during the study.
- Gross pathology:
- There were no abnormal findings
- Other findings:
- Skin irritation: There was no evidence of skin irritation.
- Interpretation of results:
- not classified
- Conclusions:
- In both sexes, the acute dermal LD50 was greater than 2100 mg/kg bw.
- Executive summary:
The purpose of the study is to determine the acute dermal toxicity of techncial GEL-ALL-MD to the rat.
Groups of 5 male and 5 female Sprague-Dawley rats received a single, 24 hour occluded, topical application of 2100 mg Technical Gel-ALL-MD/kg bodyweight, moistened with 0.5% w/v sodium carboxymethylcellulose in distilled water. A further 5 male and 5 female control animals were treated similarly except that no test material was applied to the skin. Animals were observed for 14 days after treatment and then examined post mortem.
There were no mortalities, no treatment-related clinical signs and no evidence of skin irritation. No treatment-related effects on bodyweight were recorded and no abnormalities were seen post-mortem.
In both sexes the acute dermal LD50 was greater than 2100 mg/kg bw.
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see Section 13 for "Read-across justification to support the REACH registration of Bis-O-(benzylidene)-D-glucitol (EC 251-136-4) at 10-100 tpa" for full details.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
It is proposed that the structural similarity and properties of the target substance and the structural analogue (sources substance) are sufficiently close for there to be a reasonable expectation of similar effects.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Soure substance:
IUPAC name: 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
EC number: 402-950-5
CAS number: 87826-41-3
Target Substance: Bis-O-(benzylidene)-D-glucitol
IUPAC name: 1,3:2,4-bis-O-dibenzylidene-D-glucitol
EC number: 251-136-4
CAS number: 32647-67-9
3. ANALOGUE APPROACH JUSTIFICATION
Based on the structural similarity of the source substances and target substance, similarity of physic-chemical properties and similarity in experimental (eco)toxicological test data (and toxicokinetic behaviour assessment) it is concluded that target substance and the structural analogue (source substance) are sufficiently close for there to be a reasonable expectation of similar effects, for the endpoints where results have been read-across.
4. DATA MATRIX
Please see Section 13 for "Read-across justification to support the REACH registration of Bis-O-(benzylidene)-D-glucitol (EC 251-136-4) at 10-100 tpa" for full details. - Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 100 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: There were no treatment related clinical signs during the study.
- Gross pathology:
- There were no abnormal findings
- Other findings:
- Skin irritation: There was no evidence of skin irritation.
- Interpretation of results:
- other: not classified under EU CLP
- Conclusions:
- In both sexes, the acute dermal LD50 was greater than 2100 mg/kg bw.
- Executive summary:
The purpose of the study is to determine the acute dermal toxicity of techncial GEL-ALL-MD (structural analogue source substance EC 402-950-5) to the rat.
Groups of 5 male and 5 female Sprague-Dawley rats received a single, 24 hour occluded, topical application of 2100 mg Technical Gel-ALL-MD/kg bodyweight, moistened with 0.5% w/v sodium carboxymethylcellulose in distilled water. A further 5 male and 5 female control animals were treated similarly except that no test material was applied to the skin. Animals were observed for 14 days after treatment and then examined post mortem.
There were no mortalities, no treatment-related clinical signs and no evidence of skin irritation. No treatment-related effects on bodyweight were recorded and no abnormalities were seen post-mortem.
In both sexes the acute dermal LD50 was greater than 2100 mg/kg bw.
It is proposed that this result can be used in the assessment of the target substance.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Acute dermal toxicity study results are read-across from structurally similar analogue substances.
Additional information
Justification for classification or non-classification
Acute toxicity: via oral route: The test material did not meet the criteria for classification as acutely toxic via the oral route according to Regulation 1272/2008 (CLP) as the LD50 of >2000 mg/kg is above the threshold for classification.
Acute toxicity: via dermal route: The test material did not meet the criteria for classification as acutely toxic via the dermal route according to Regulation 1272/2008 (CLP) as the LD50 of >2000 mg/kg is above the threshold 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.