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EC number: 212-990-3 | CAS number: 903-19-5
- 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, rat (OECD 420): LD50 (m/f) > 2000 mg/kg bw
- Acute dermal toxicity, rat (OECD 402): LD50 (m/f) > 2000 mg/kg bw
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:
- 04 Oct - 07 Nov 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Annex to Directive 92/69/EEC (OJ No. L383A, 29,12,92), Part B, Method B.1)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- Adopted 17 Dec 2001.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Good Laboratory Practice, The United Kingdom Compliance Programme, Department of Health and Social Security 1986 and subsequent revision, Department of Health, UK
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Hsd/Ola: Sprague-Dawley (CD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, UK
- Females: yes
- Age at study initiation: 4 - 7 wks
- Weight at study initiation: 94 - 100 g (males range), 99 - 105 g (females range)
- Fasting period before study: animals were fasted overnight prior to and approximately 4 hours after dosing
- Housing: groups of up to 5 rats of the same sex per cage, in metal cages with mesh floors
- Diet: SDS LAD 1, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 24 Oct 1995 To: 07 Nov 1995 - Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 1%, aqueous
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% w/v
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: limit test in compliance with Test Guideline OECD420. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality, morbidity and clinical signs soon after dosing and at frequent intervals on Day 1, then twice daily for 14 days. The bodyweight of each rat was recorded on Day 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- Individual weekly bodyweight changes and group mean bodyweights.
- Key result
- 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: 2000 mg/kg bw: piloerection was observed in all rats within 5 min of dosing, recovery was complete in all instances by three hours after dosing. There were no other clinical signs.
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed on Day 15.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The acute lethal oral dose (LD50) to rats of AF-317 was found to be greater than 2000 mg/kg bw.
Reference
Dose [mg/kg bw] |
Mortality |
Clinical Signs |
N |
N |
|
Males |
||
2000 |
0/5 |
5/5 |
Females |
||
2000 |
0/5 |
5/5 |
N = Number of animals dosed
Clinical Signs = Piloerection was observed in all rats, completely resolving in all instances by 3 hours after dosing
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
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:
- 15 Apr - 29 Apr 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- no information on test substance formulation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- Annex V to Directive 92/69/EEC (OJ No. L383A, 29,12,92) , Part B , Methods for the determination
of Toxicity , B.3 - Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Expiration date of the lot/batch: 03 July 1999
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar strain Crl : (WI) BR (outbred, SPF-Quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: Young adult animals (approx. 9 weeks old)
- Weight at study initiation: Males: 328 +/- 22 g (mean +/- SD); Females: 222 +/- 12 g (mean +/- SD). Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: No
- Housing: Individually housed in labelled poycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands)
- Diet: Standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium), ad libitum
- Water: Free access to tap water , ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back (one day before exposure an area of approx. 5 x 7 cm was clipped)
- % coverage: Approx. 10% of the total body surface, i. e. approx. 25 square cm for males and 18 square cm for females
- Type of wrap if used: Nonwoven swab ( Dispomed® L) covered with aluminium foil and Coban flexible bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only. Suppliers: Lohmann, Neuwied, Germany (Dispomed) and 3M, St. Paul, USA (Coban & Micropore).
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, with a tissue moistened with tap water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 10 mL/kg bw
- 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: Mortality / Viability: twice daily, body weight: Day 1 (pre-administration), 8 and 15, clinical signs: at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15
- Necropsy of survivors performed: Yes - Statistics:
- No
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Red staining of the head, neck and / or periorbital region was noted in three animals on Day 2. Erythema (Grade 1), scales and scabs were seen in the treated skin-area among some animals between Days 3 and 6. Brown staining of the skin on the back by the
- Gross pathology:
- Pelvic dilatation in the right kidney, found in one female at macroscopic post mortem examination, is commonly noted among rats of this age and strain and was therefore not considered to be toxicologically significant. No further abnormalities were noted among the animals.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The acute lethal dermal dose (LD50) of AF-317 to rats was found to be greater than 2000 mg/kg bw.
Reference
Table 1. Mortality and clinical signs in the acute dermal toxicity study.
Dose [mg/kg bw] |
Mortality |
Clinical signs |
N* |
N* |
|
Males |
||
2000 |
0/5 |
3/5 |
Females |
||
2000 |
0/5 |
4/5 |
*N= Number of animals / number of animals used |
Clinical signs: Red staining of the head, neck and / or periorbital region was noted in three animals (2 males and 1 female) on Day 2. Erythema (Grade 1), scales and scabs were seen in the treated skin-area among some animals (2 males and 3 females) between Days 3 and 6. Brown staining of the skin on the back by the test substance was noted in two females on Day 2.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.
Additional information
Acute oral toxicity
A reliable acute toxicity study conducted under GLP with 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone (CAS 903-19-5) in five male and female Sprague-Dawley rats according to OECD guideline 420 is available (Key, 1996). In this study the test substance diluted in methylcellulose was orally administered via gavage at a dose of 2000 mg/kg bw, and thereafter the rats were observed for 14 days. No mortality occurred during the study period. Piloerection was observed in all rats within 5 min of dosing, while the recovery was complete in all instances by 3 hours after dosing. Slightly low bodyweight gains were recorded for 2/5 male rats on both Day 8 and 15, while all other rats achieved satisfactory bodyweight gains throughout the study. No macroscopic abnormalities were observed during the macroscopic evaluation. Based on the results of the conducted study, a LD50 value of > 2000 mg/kg bw was derived for male and female rats.
Acute dermal toxicity
In an acute dermal toxicity study conducted under GLP conditions and according to OECD guideline 402, five male and female Wistar rats were exposed for 24 h to 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone (CAS 903-19-5) in propylene glycol at a dose level of 2000 mg/kg bw under occlusive conditions (Key, 1998). The fur of all rats was clipped one day prior to testing. The animals were observed for 14 days for signs of systemic toxicity and mortality. No mortality occurred during the study period. Red staining of the head, neck and / or periorbital region was noted in 2/5 males and 1/5 females on Day 2. Erythema (Grade 1), scales and scabs were seen in the treated skin-area among 2/5 males and 3/5 females between Days 3 and 6. Brown staining of the skin on the back by the test substance was noted in 2/5 females on Day 2. The changes noted in mean body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.Pelvic dilatation in the right kidney, found in one female at macroscopic post mortem examination, is commonly noted among rats of this age and strain and was therefore not considered to be toxicologically significant. No further abnormalities were noted among the animals. Based on the results of the conducted study, the LD50 value was derived to be > 2000 mg/kg bw for male and female rats.
Justification for classification or non-classification
The available data on acute oral and dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008 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.
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