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EC number: 209-235-5 | CAS number: 562-74-3
- 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
Oral:
In an acute oral toxicity study similar to OECD Guideline 401 in rats (MB Research Lab, 1977), an LD 50 of 1300 mg/kgbw was determined.
Dermal:
In an acute dermal toxicity study similar to OECD Guideline 402 in rabbits (MB Research Lab, 1977), an LD 50 > 2500.0 and < 5000.0 mg/kg bw was determined.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 10 animals/group, no record of bodyweight/gain
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Sample markings: 76-363, 4-TERPINENOL - Species:
- rat
- Route of administration:
- oral: unspecified
- Doses:
- 0.6, 1.22, 2.47, and 5.0 g/kg
- No. of animals per sex per dose:
- 10 per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at least once a day
- Necropsy of survivors performed: yes - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 1 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In the 0.6 g/kg dose group one animal died. In the 1.22 g/kg dose group, 4 animals died. In the 2.47 g/kg dose group, 9 animals died and in the 5.0 g/kg dose group, all animals died. In all dose groups, the animals died on day 1 after administration of the test substance.
- Clinical signs:
- other: Symptomatology Rats: 0.6 g/kg - ataxia, lethargy, tremors, chromorhinorrhea, chromodacryorrhea 1.22 g/kg - lethargy, ptosis, pile-erection chromorhinorrhea 2.47 g/kg - salivation, chromorhinorrhea, ataxia 5.0 g/kg - coma and death
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions chosen and the results obtained, the test substance is considered to be classified as acute toxic category 4 (H302: harmful if swallowed). The LD50 was reported to be 1.3 g/kg.
- Executive summary:
An acute toxicity test via the oral route was performed pre-GLP. The test was equivalent or similar to the OECD guideline 401. Ten rats per dose group were treated with 0.6, 1.22, 2.47, and 5.0 g/kg of the test substance of which died at the first observation day 1/10, 4/10, 9/10, and 10/10, respectively. The LD50 was reported to be 1.3 g/kg. Necropsy observations revealed dark lungs, dark liver, dark kidneys, and areas of redness in intestines, among others.
Reference
Necroscopy Observations
Dose g/kg |
0.6 |
1.22 |
2.47 |
5.0 |
Lungs dark |
1 |
4 |
9 |
9 |
Liver dark |
1 |
4 |
8 |
7 |
Areas of redness in intestines |
1 |
4 |
6 |
6 |
Kidneys dark |
1 |
2 |
2 |
3 |
Dried blood around eyes |
|
|
3 |
|
Yellow exudate - nose and mouth |
|
|
3 |
|
Portions of intestines yellow |
|
|
3 |
|
Portions of stomach red |
|
|
3 |
|
Bloody urine in bladder |
|
|
2 |
|
Red exudate - mouth |
|
|
2 |
|
Kidneys mottled |
|
3 |
1 |
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 300 mg/kg bw
- Quality of whole database:
- Sufficient for the determination of the LD50.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- no record of the body weight/-gain
- GLP compliance:
- no
- Remarks:
- pre GLP-Study
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Sample markings 76-363, 4-TERPINENOL - Species:
- rabbit
- Doses:
- 1.25, 2.5, and 5.0 g/kg
- No. of animals per sex per dose:
- 4 per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at least once a day
- Necropsy of survivors performed: yes - Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: mortality was observed
- Mortality:
- In the 5.0 g/kg dose group, 3 animals died within day 1. One more animal died on day 2
- Clinical signs:
- other: Ataxia and negative righting reflex in 1/each at 5.0 g/kg.
- Other findings:
- Skin Irritation:
- Redness: 1.25 g/kg: Moderate-2, severe-2
2.5 g/kg - Moderate - l, severe - 3
5.0 g/kg - severe - l
- Edema - moderate in all - Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the conditions chosen, the test substance revealed a LD50 of greater than 2.5 g/kg.
- Executive summary:
A dermal toxicity test in rabbits pre-GLP was conducted. The test was equivalent or similar to the OECD guideline 402. Four animals per dose group were treated with 1.25, 2.5, and 5.0 g/kg of the test substance. Three animals and one animal of the highest test group died on the first day of observation and on the second day of observation, respectively. No deaths occurred at the lower dose groups. Systemic effects were observed to be ataxis and negative righting reflex in each animal at 5.0 g/kg. Skin irritation, from moderate to severe, was observed in all animals. The LD50 was reported to be greater than 2.5 g/kg.
Reference
Necropsy observations
Dose g/kg |
1.25 |
2.5 |
5.0 |
Reddish urine | 1 | ||
Liver mottled | 3 | ||
Area of exposure edematous | 3 | ||
Urine very dark | 1 | ||
Light eschar formation in exposure area |
2 |
2 |
1 |
Areas of lung dark |
|
|
2 |
Portions of intestinal wall white |
|
|
1 |
Yellow exudate - nose |
|
|
1 |
Areas of stomach yellow |
|
|
1 |
Heavy eschar formation in area of exposure |
1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Sufficient for classification.
Additional information
Oral:
In the available study (MB Research Lab, 1977) the acute toxic effects of p-menth-1-en-4-ol were investigated after a single oral gavage to rats similar to the OECD Guideline 401. The test substance was administered once orally via gavage to rats (male/female not specified, 10 animals/dose) at doses of 0.6, 1.22, 2.47, and 5.0 g/kg bw. Body weight was not determined. Clinical observations were performed at least once per day during the 14 days observation period and all animals were sacrificed and necropsied at the end of the observation period. Following clinical signs were observed: 0.6 g/kg bw - ataxia, lethargy, tremors, chromorhinorrhea, chromodacryorrhea; 1.22 g/kg bw - lethargy, ptosis, pile-erection chromorhinorrhea; 2.47 g/kg bw - salivation, chromorhinorrhea, ataxia; 5.0 g/kg bw - coma and death. In the 0.6 g/kg dose group, 1 animal died. In the 1.22 g/kg bw dose group, 4 animals died. In the 2.47 g/kg bw dose group, 9 animals died and in the 5.0 g/kg bw dose group, all animals died. In all dose groups, the animals died on day 1 after administration of the test substance.
Based on the mortality, a LD50 of 1300.0 mg/kg bw was determined.
Dermal:
In an acute dermal toxicity study similar to OECD Guideline 402 (MB Research Lab, 1977) groups of adult rabbits (4/dose, sex not specified) were dermally exposed to p-menth-1-en-4-ol at doses of 1.25, 2.5, and 5.0 g/kg bw. Animals then were observed for 14 days. Following treatment related clinical signs were observed: ataxia and negative righting reflex at 5.0 g/kg. No mortality occured in the 1.25 and 2.5 g/kg bw dose group. All (4) animals died within the first two days after test substance application in the 5.0 g/kg bw dose group. A dermal LD50 of > 2500 and < 5000 mg/kg bw was determined.
Specific target organ toxicity - single exposure:
In both oral and dermal acute toxicity studies, effects relating to transient neurodepression were observed. In the acute dermal toxicity study in rabbits, 1 animal at the top dose of 5000 mg/kg bw showed ataxia and negative righting reflex. In the acute oral toxicity study, the high dose animals (5000 mg/kg bw) were comatose and died following test substance administration. Animals in the 2470 and 600 mg/kg bw dose groups showed ataxia, and at 600 and 1220 mg/kg bw additionally lethargy was observed. Taken together, these symptoms indicate transient neurodepression related to test substance administration and justify classification with STOT SE 3, H336 (may cause drowsiness and dizziness).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.
An oral LD50 of 1300.0 mg/kg bw was determined. As a result the test substance is considered to be classified for acute oral toxicity (Category 4, H302) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
In an acute dermal toxicity study a dermal LD50 > 2500 mg/kg bw was detrmined. Thus, the test substance is not considered to be classified for acute dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
Additionally classification for specific target organ toxicity after single exposure (STOT SE 3), H336, is considered justified based on the results observed in acute oral and acute dermal toxicity studies. Thus, the substance is to be classified with STOT SE 3 (H336) under Regulation (EC) 1272/2008 (CLP).
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