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EC number: 220-499-0 | CAS number: 2785-87-7
- 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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Pre-guideline and pre-GLP study. Only basic data given but the study is comparable to OECD TG 401.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- No data
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Pre-guideline and pre-GLP study. No details on method (abraded skin or not, occlusive conditions or not). 4 animals/dose used (only 2 animals for highest dose group). Clinical signs were not observed at the two highest doses tested. Lack of coherence with respect to the rat dermal and oral data. Therefore, the study was not considered reliable for the risk assessment.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no details on test substance, test animals, environmental condition of animal room; 4 animals/dose used (2 animals for highest dose group); body weight, method of LD50 calculation not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- No data
- Duration of exposure:
- No data
- Doses:
- 79, 313, 1250 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 4 animals/dose (except highest dose group where 2 animals used)
- 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 and clinical signs daily for 14 days.
- Necropsy of survivors performed: Yes; animals that died during study and all surviving animals were subjected to gross necropsy at the end of the study period. - Statistics:
- None
- Preliminary study:
- Not applicable
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 310 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 160 - <= 600
- Mortality:
- - No mortality was observed at 79 mg/kg bw.
- 2/4, 4/4 and 2/2 animals died within 2 days post treatment at 313, 1250 and 5000 mg/kg bw, respectively - Clinical signs:
- other: - Lethargy, slight ataxia, tachypnea, negative righting reflex, dyspnea and pupillary dilation were noted in one animal treated with 313 mg/kg bw on Day 2. Lethargy was noted in another animal from same treatment group on Day 14. - At 79 mg/kg bw: 1/4 an
- Gross pathology:
- - At 79 mg/kg bw: 3/4 animals showed red intestines areas and dark liver.
- At 313 mg/kg bw: Pale kidney, white nodules throughout the lung and red intestine areas were noted in 1/4 animals. 2/4 animals showed dark liver and lung, skin oedema and redness.
- At 1250 mg/kg bw: All animals showed mottled liver, dark lungs and skin redness. Dark spleen, kidney and liver were observed in 1/4 animals. 3/4 animals showed red intestinal areas, bloated intestine, skin oedema, brown anogenital exudate and red nose/mouth exudate.
- At 5000 mg/kg bw: Mottled liver, dark kidney, red intestinal areas, skin redness and oedema were observed in all animals. One animal showed dark lung and reduced spleen size. - Other findings:
- None
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The study is a pre-guideline and pre-GLP study. No details on method (abraded skin or not, occlusive conditions or not). 4 animals/dose used (only 2 animals for highest dose group). Clinical signs were not observed at the two highest doses tested. There was a lack of coherence with respect to the rat dermal and oral data. Therefore, the study was not considered reliable for the risk assessment.
- Executive summary:
In an acute dermal toxicity study, groups of rabbits (4/dose except high dose where 2 animals used) were given single dermal application of test material at 79, 313, 1250 and 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
No mortality was observed at 79 mg/kg bw. 2/4, 4/4 and 2/2 animals died within 2 days post treatment at 313, 1250 and 5000 mg/kg bw, respectively. Lethargy, slight ataxia, tachypnea, negative righting reflex, dyspnea and pupillary dilation were noted in at 313 mg/kg bw. Slight skin redness was observed at 79 mg/kg bw. Slight to severe skin redness and oedema were observed in animals treated with 313 and 1250 mg/kg bw. No macroscopic abnormalities were observed in 1/4 animals at 79 and 313 mg/kg bw. At 79 mg/kg bw, gross necropsy revealed red intestines areas and dark liver in remaining animals. At 313 mg/kg bw, pale kidney, red intestine areas, white nodules in the lung, dark liver and lung, skin oedema and redness were observed. At 1250 mg/kg bw, mottled liver, dark lungs, spleen, kidney and liver, skin redness, red intestinal areas, bloated intestine, skin oedema, brown anogenital exudate and red nose/mouth exudate were observed. At 5000 mg/kg bw, mottled liver, dark kidney/lung, red intestinal areas, skin redness and oedema were observed.
Rabbit Dermal LD50 = 310 mg/kg bw (95 % confidence limits of 160-600 mg/kg bw)
Under the test conditions, the test material is classified as ‘Category 3’ according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
However, the study is a pre-guideline and pre-GLP study. No details on method (abraded skin or not, occlusive conditions or not). 4 animals/dose used (only 2 animals for highest dose group). Clinical signs were not observed at the two highest doses tested. There was a lack of coherence with respect to the rat dermal and oral data. Therefore, the study was not considered reliable for the risk assessment.
None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (no details on test substance, test animals, environmental conditions of animal room and body weight. )
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-methoxy-4-propylphenol
- EC Number:
- 220-499-0
- EC Name:
- 2-methoxy-4-propylphenol
- Cas Number:
- 2785-87-7
- Molecular formula:
- C10H14O2
- IUPAC Name:
- 2-methoxy-4-propylphenol
- Test material form:
- not specified
- Details on test material:
- None
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- no data
- Doses:
- 1220, 1730, 2470 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals/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 toxicity and clinical signs daily for 14 days.
- Necropsy of survivors performed: Yes - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 600 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 900 - <= 3 600
- Mortality:
- Mortality was observed in 1/10 (Day 1), 4/10 (3 animals died on Day 1; one animal died on Day 2) and 10/10 animals (Day 1) at 1730, 2470 and 5000 mg/kg bw, respectively. No mortality was observed at 1220 mg/kg bw.
- Clinical signs:
- other: Lethargy was observed in all dose groups. Also, chromodacryorrhea, ptosis and ataxia were observed at 1220, 1730 and 2470 mg/kg bw, respectively.
- Gross pathology:
- - No macroscopic abnormalities were observed in 8/10, 8/10, 6/10 and 0/10 animals at 1220, 1730, 2470 and 5000 mg/kg bw, respectively.
- Necropsy of remaining animals revealed red/yellow/bloated intestines; red/bloated stomach; dark/mottled liver; kidneys - dark at 1730, 2470 and 5000 mg/kg bw; lungs dark at 2470 and 5000 mg/kg bw; yellow anogenital exudate at 2470 mg/kg bw and red nose/mouth exudate at 2470 and 5000 mg/kg bw. - Other findings:
- None
Any other information on results incl. tables
Table 7.2.1.1 – Distribution of mortality
|
Observation day |
|||||||||||||
Dose (mg/kg bw) |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
1220 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1730 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2470 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5000 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions, test material is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- classified as category 5 according to the GHS since rat Oral LD50 is lower than 5000 mg/kg bw (2600 mg/kg bw) - Executive summary:
In an acute oral toxicity study, performed similarly to OECD Guideline No. 401, groups of rats (10 animals/dose) were administered a single oral dose of test material at 1220, 1730, 2470 and 5000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
All ten animals died at 5000 mg/kg bw. 1/10 and 4/10 animals died at 1730 and 2470 mg/kg bw. No mortality was observed at 1220 mg/kg bw. Lethargy was observed in all dose groups. Also chromodacryorrhea, ptosis and ataxia were observed at 1220, 1730 and 2470 mg/kg bw, respectively. No macroscopic abnormalities were observed in 8/10, 8/10, 6/10 and 0/10 animals at 1220, 1730, 2470 and 5000 mg/kg bw, respectively. Necropsy of remaining animals revealed red/yellow/bloated intestines; red/bloated stomach; dark/mottled liver; kidneys dark at 1730, 2470 and 5000 mg/kg bw; lungs dark at 2470 and 5000 mg/kg bw; yellow anogenital exudate at 2470 mg/kg bw and red nose/mouth exudate at 2470 and 5000 mg/kg bw.
Rat Oral LD50 = 2600 mg/kg bw (95% Cl: 1900-3600 mg/kg bw).
Under the test conditions, test material is:
- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw
- classified as category 5 according to the GHS since rat Oral LD50 is lower than 5000 mg/kg bw (2600 mg/kg bw)
This study is considered as acceptable and satisfies the requirement for acute oral toxicity
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