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EC number: 202-794-6 | CAS number: 99-85-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes (incl. QA statement)
- Justification for study design:
- The study was designed to evaluate the potential toxic effect of the test item Gamma Terpinene when administered to rats for a minimum of 28 days and to evaluate the potential of the test item to affect male and female reproductive performance such as gonadal function, mating behaviour, conception, parturition, and early postnatal development. The study was performed in compliance with the OECD Test Guideline No.422, Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test, Adopted: 29 July, 2016.
Test material
- Reference substance name:
- p-mentha-1,4-diene
- EC Number:
- 202-794-6
- EC Name:
- p-mentha-1,4-diene
- Cas Number:
- 99-85-4
- Molecular formula:
- C10H16
- IUPAC Name:
- p-mentha-1,4-diene
Constituent 1
- Specific details on test material used for the study:
- Clear, liquid.
Storage: Room temperature (20 ± 5°C); keep away of light
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Duration of treatment / exposure:
- 28d
- Frequency of treatment:
- Females were treated during:
14-day pre-mating,
14-day mating (maximum)
22-day gestation (approximately)
13-day lactation
Males were treated during:
14-day pre-mating,
14-day mating (maximum)
The animals designated for post-treatment observation (5 animals per sex in control and high groups, respectively) remained untreated for subsequent 14 days.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Description (incidence and severity):
- There were no test item-related deaths of animals during the study. Animals lived through the observation period without significant visible clinical signs.
Lethargy in 2 males (ID 4-Control and 33-Mid) was observed on Day 7 of treatment. Lethargy, spasm and tremor was observed in females: ID 102, 103, 108 (High) and ID 84, 89, 63 (Mid) between Day 4 and Day 7 of treatment. No other signs were observed. - Mortality:
- no mortality observed
- Description (incidence):
- There were no test item-related deaths of animals during the study. Animals lived through the observation period without significant visible clinical signs.
- Body weight and weight changes:
- not specified
- Description (incidence and severity):
- The body weight of males of all dose groups was mildly increasing during the study. No significant differences between control and dose groups were observed. The body weight of High dose satellite males was similar in comparison with recovery control males during the whole study.
The body weight of females of all dose groups was mildly increasing during the study. Only significant difference between Control group and Low group on Day1 of the treatment in females was noticed. The body weight of recovery High dose females was similar in comparison with recovery control females during the whole study. - Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- Food consumption of males of all dose groups was similar to the control males during the whole study. Food consumption of recovery treated males was similar in comparison with control group during the whole application and recovery period.
Food consumption of treated females was similar or slightly lower in comparison with control group during the whole application period. Food consumption of recovery treated females was similar in comparison with recovery control females for the whole study. - Haematological findings:
- not specified
- Description (incidence and severity):
- Only statistically significant decrease of haemoglobin in males of High group and females of Mid group against Control group were registered. These sporadic changes had no dose relationship; they were considered to be a result of intra-individual and inter-individual variability for this species or they have only statistical character.
No test item related effect on the haematology parameters were observed in this study. During the study, haematology parameters in both sexes were within or close to the historical control data for this species. - Clinical biochemistry findings:
- not specified
- Description (incidence and severity):
- There were no findings in clinical chemistry parameters which could be definitively attributed to the treatment.
Statistical evaluation of clinical chemistry results showed no differences between control and dose groups. The average values of clinical chemistry parameters in all animals were within or slightly outside the serum historical control data. - Urinalysis findings:
- not specified
- Description (incidence and severity):
- No significant changes against normal physiological conditions were detected. In the urine of some animals, small amounts of protein, ketones and presence of blood (erythrocytes) were observed. There are no differences between control and the dose groups. These findings considered to be normal (9). No test item related effect was observed.
- Behaviour (functional findings):
- not specified
- Description (incidence and severity):
- Open field test
The locomotor activity was not influenced by the administration of tested compounds in neither experimental group compared to Control.
Tail flick Test
In comparison with Control group, the reaction time was not significantly influenced by the administration of test item.
Grip Strength Test
Statistically significant difference between the Control and the Low group was observed. This significance has probably statistical character. Other differences observed within the males group were not statistically significant.
As to the group of females, male satellites and female satellites, there is not a statistically significant difference between the means of component groups. - Organ weight findings including organ / body weight ratios:
- not specified
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on the systemic toxicity
Target system / organ toxicity (P0)
open allclose all
- Key result
- Critical effects observed:
- no
- System:
- urinary
- Key result
- Critical effects observed:
- no
- System:
- haematopoietic
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Description (incidence and severity):
- There were no test item-related deaths of animals during the study. Animals lived through the observation period without significant visible clinical signs.
Lethargy in 2 males (ID 4-Control and 33-Mid) was observed on Day 7 of treatment. Lethargy, spasm and tremor was observed in females: ID 102, 103, 108 (High) and ID 84, 89, 63 (Mid) between Day 4 and Day 7 of treatment. No other signs were observed. - Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- There were no test item-related deaths of animals during the study.
- Body weight and weight changes:
- not specified
- Description (incidence and severity):
- The body weight of males of all dose groups was mildly increasing during the study. No significant differences between control and dose groups were observed. The body weight of High dose satellite males was similar in comparison with recovery control males during the whole study.
The body weight of females of all dose groups was mildly increasing during the study. Only significant difference between Control group and Low group on Day1 of the treatment in females was noticed. The body weight of recovery High dose females was similar in comparison with recovery control females during the whole study. - Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- Food consumption of males of all dose groups was similar to the control males during the whole study. Food consumption of recovery treated males was similar in comparison with control group during the whole application and recovery period.
Food consumption of treated females was similar or slightly lower in comparison with control group during the whole application period. Food consumption of recovery treated females was similar in comparison with recovery control females for the whole study. - Haematological findings:
- not specified
- Description (incidence and severity):
- Only statistically significant decrease of haemoglobin in males of High group and females of Mid group against Control group were registered. These sporadic changes had no dose relationship; they were considered to be a result of intra-individual and inter-individual variability for this species or they have only statistical character.
No test item related effect on the haematology parameters were observed in this study. During the study, haematology parameters in both sexes were within or close to the historical control data for this species. - Clinical biochemistry findings:
- not specified
- Description (incidence and severity):
- There were no findings in clinical chemistry parameters which could be definitively attributed to the treatment.
Statistical evaluation of clinical chemistry results showed no differences between control and dose groups. The average values of clinical chemistry parameters in all animals were within or slightly outside the serum historical control data. - Urinalysis findings:
- not specified
- Description (incidence and severity):
- No significant changes against normal physiological conditions were detected. In the urine of some animals, small amounts of protein, ketones and presence of blood (erythrocytes) were observed. There are no differences between control and the dose groups. These findings considered to be normal (9).
- Organ weight findings including organ / body weight ratios:
- not specified
- Description (incidence and severity):
- Relative weights of the liver in the Low, Mid and High dose males were significantly increased compared to Control group. Significant increase of kidney and spleen relative weight and decrease of relative weight of thymus in High dose against Control were observed. In satellite males no differences between Control and High dose were observed. No findings were seen in females.
- Gross pathological findings:
- not specified
- Description (incidence and severity):
- All animals were necropsied. During necropsy, hydrometra and uterus filled with blood were observed in two females. No other macroscopically changes were noticed.
- Histopathological findings:
- not specified
Effect levels (F1)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: reproduction
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Based on the reproduction toxicity
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Based on the systemic toxicity
Target system / organ toxicity (F1)
open allclose all
- Key result
- Critical effects observed:
- no
- System:
- urinary
- Key result
- Critical effects observed:
- no
- System:
- haematopoietic
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 250 mg/kg bw/day
- Treatment related:
- yes
- Relation to other toxic effects:
- not specified
Applicant's summary and conclusion
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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