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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
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- 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
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- Nanomaterial pour density
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- 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

Acute Toxicity: dermal
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- EC Number:
- 212-990-3
- EC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- Cas Number:
- 903-19-5
- Molecular formula:
- C22H38O2
- IUPAC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
Constituent 1
- 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
Test animals
- 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
Administration / exposure
- 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
Results and discussion
Effect levels
- 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.
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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