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EC number: 403-920-4 | CAS number: 107551-67-7 G 19-675 ZP
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Feb. 8, 1988 to Apr. 25, 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guideline, with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
- EC Number:
- 403-920-4
- EC Name:
- 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
- Cas Number:
- 107551-67-7
- Molecular formula:
- C13H18O3
- IUPAC Name:
- 3-(3-tert-butyl-4-hydroxyphenyl)propanoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd. (Animal Production)
- Age at study initiation: 7 to 8 weeks.
- Weight at study initiation: 176 to 228 g.
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: Segregated by sex, group housed (5 animals/cage) in Macrolon cages type 4, with standardized soft wood bedding.
- Diet (e.g. ad libitum): Rat chow, ad libitum.
- Water (e.g. ad libitum): Water, ad libitum.
- Acclimation period: At least 5 days before administration.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C.
- Humidity (%): 55±10%.
- Air changes (per hr): 15 air change per hr.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500, 1000, and 2000 mg/kg body weight.
- Amount of vehicle (if gavage): 10 mL/kg body weight.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight. - Doses:
- 500, 1000, and 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 500 mg/kg body weight group: 5 males/group
1000 mg/kg body weight group: 5/sex/group
2000 mg/kg body weight group: 5 females/group - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: Daily.
Body weight: At start and on Days 7, 14, and at death.
Necropsies: Spontaneously dying animals were submitted to a gross necropsy as soon as possible
- Necropsy of survivors performed: Yes. - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 000 - 2 000 mg/kg bw
- Mortality:
- See Table 1.
- Clinical signs:
- other: Ruffled fur, dyspnea, hunched posture, and exophthalmos were seen, being common symptoms in acute tests. Additionally, slightly to severely reduced spontaneous activity was observed in the spontaneously died animals dosed with 2000 mg/kg bw. The surviving
- Gross pathology:
- At autopsy, a spotted thymus was observed in one female given 1000 and in four females given 2000 mg/kg bw.
Edematous lungs were found in one female and a liquid-filled thoracic cavity in three females of the 2000 mg/kg bw dose group, respectively. - Other findings:
- Not available.
Any other information on results incl. tables
Table 1. Rate of Deaths
Dose mg/kg |
Totals |
Time of Death |
|||||||||||||||||||
In group |
Deaths |
Deaths |
Hours after treatment |
Days of Post-exposure Period |
|||||||||||||||||
No. |
% |
1 |
2 |
3 |
5 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
>14 |
||
Males |
|||||||||||||||||||||
500 |
5 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1000 |
5 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Females |
|||||||||||||||||||||
1000 |
5 |
0 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2000 |
5 |
5 |
100 |
|
|
|
|
2 |
2 |
1 |
|
|
|
|
|
|
|
|
|
|
|
Table 2. Signs and Symptoms
Observation |
Exposure day: hours |
Days of post-exposure period |
||||||||||||||||
|
1 |
2 |
3 |
5 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
>13 |
500 mg/kg males |
||||||||||||||||||
ruffled fur |
XX |
XX |
XX |
XX |
X |
X |
X |
X |
X |
x |
x |
x |
|
|
|
|
|
|
dyspnea |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
|
|
|
|
hunched post |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
|
|
|
|
|
|
|
1000 mg/kg males |
||||||||||||||||||
ruffled fur |
X |
X |
X |
X |
X |
X |
X |
X |
X |
x |
x |
x |
x |
x |
|
|
|
|
dyspnea |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
|
|
|
|
hunched post |
X |
X |
X |
X |
X |
|
|
|
|
|
|
|
|
|
|
|
|
|
1000 mg/kg females |
||||||||||||||||||
ruffled fur |
XX |
XX |
XX |
XX |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
dyspnea |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
|
|
hunched post. |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
|
|
|
|
|
exophthalmos |
|
|
|
|
X |
|
|
|
|
|
|
|
|
|
|
|
|
|
2000 mg/kg females |
||||||||||||||||||
ruffled fur |
XX |
XX |
XX |
XX |
XX |
X |
|
|
|
|
|
|
|
|
|
|
|
|
dyspnea |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
|
|
|
|
|
|
|
hunched post. |
X |
X |
X |
X |
X |
|
|
|
|
|
|
|
|
|
|
|
|
|
ventr. lecuiib. |
x* |
x* |
x* |
x* |
x* |
X |
|
|
|
|
|
|
|
|
|
|
|
|
red.spcn.act. |
X |
X |
X |
X |
XX |
XXX |
|
|
|
|
|
|
|
|
|
|
|
|
X =- slight XX = moderate xxx = marked
hunched post. = hunched posture
ventr.recumb. = ventral recumbency
red.spcn.act. = reduced spontaneous activity
* = only in one animal
Table 3. Mean Body Weight and Standard Deviation
Males |
Females |
|||||
Dose (mg/kg) |
Day 1 |
Day 7 |
Day 14 |
Day 1 |
Day 7 |
Day 14 |
500 |
220/ 6.2 |
296/ 7.9 |
355/ 13.1 |
- |
- |
- |
1000 |
211/7.3 |
261/ 10.7 |
322/ 18.7 |
185/ 5.5 |
215/ 7.5 |
235/ 5.5 |
2000 |
- |
- |
|
184/ 9.2 |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Single oral application of the test item induced spontaneous death of all female animals in the high dose group (2000 mg/kg) until day 3 of the post observation period. Therefore LD50 is considered to be > 1000 mg/kg but < 2000 mg/kg bw.
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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