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EC number: 232-087-8 | CAS number: 7785-70-8
- 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
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Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From April 28 to August 5, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OECD Guideline 414 with a minor deviation as only 2 doses were tested but up to the limit dose of 1000 mg/kg/day
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- only 2 doses tested but up to the limit dose of 1000 mg/kg/day
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Camphene
- EC Number:
- 201-234-8
- EC Name:
- Camphene
- Cas Number:
- 79-92-5
- Molecular formula:
- C10H16
- IUPAC Name:
- 2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane
- Reference substance name:
- 3,3-dimethyl-2-methylidenebicyclo[2.2.1]heptane
- IUPAC Name:
- 3,3-dimethyl-2-methylidenebicyclo[2.2.1]heptane
- Details on test material:
- - Name of test material (as cited in study report): Camphene
- Substance type: Technical grade
- Physical state: Vitreous, colourless, waxy-crystalline solid
- Analytical purity: 78%
- Lot/batch No.: 54/90
- Stability under test conditions: 12 months at 25 °C; solution in sesame oil is stable for 4 hours
- Storage condition of test material: Cool in a well-closed container
- Solubility: Medium solubility in sesame oil
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH, Germany
- Stock: Tif: RAI f (SPF)
- Age at study initiation: 54 days
- Weight at study initiation: 180-190 g
- Fasting period before study:
- Housing: Individually housed in MAKROLON cages type III
- Diet (e.g. ad libitum): ALTROMIN 1314 (ALTROMIN GmbH, Lage/Lippe, Germany), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 15%
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil, DAB 10
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test solutions were freshly prepared in sesame oil each day immediately before dosing
VEHICLE
- Justification for use and choice of vehicle (if other than water): Test material was soluble in sesame oil
- Amount of vehicle (if gavage): 5 mL/kg bw
- Lot/batch no. (if required): 2009
- Source: Henry Lamotte, Bremen, Germany - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - Concentrations: 50 and 200 mg/mL suspension
- Sampling interval: Sampled at start and termination of treatment
- Sample storage conditions before analysis: Samples were deep-frozen at -20 °C or cooler until dispatch
- Analytical method: Gas chromatography with FID detector - Details on mating procedure:
- - Impregnation procedure: Cohoused
- If cohoused:
- M/F ratio per cage: 1:1
- Length of cohabitation: Overnight
- Proof of pregnancy: Sperm in vaginal smear referred to as Day 0 of pregnancy. If the smear was negative, mating was repeated.
- Fertile (proved) male rats of the same breed were repeatedly employed for mating, at the earliest 3 days after successful copulation - Duration of treatment / exposure:
- Day 6-15 of pregnancy
- Frequency of treatment:
- Once daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
250 and 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 20 pregnant females per dose (plus 5 females per dose as reserve)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses were selected on the basis of a pilot study. In this limit test study, camphene (1000 mg/kg bw/day) was administered to 3 pregnant rats from Day 6 to 15 of pregnancy. Except for a slight transient reaction after the first dosing, 1000 mg/kg bw/day was well-tolerated by the dams and did not influence the prenatal development.
- Rationale for animal assignment (if not random): Rats were assigned to their respective group according to their mating day i.e. in a cyclic way following the listing of positive findings in the vaginal smear.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
- Cage side observations were included: Behaviour, external appearance, mortality and faeces
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: Daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: Daily
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation Day 20 under ether
- Organs examined: Ovaries and uteri - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations and location of fetuses in the uterus: Yes
- Number and size of resorptions: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: Fetuses and placentae count, sex and viability of fetuses, weight of ovaries, weight and length of fetuses and weight of placentae - Fetal examinations:
- - External examinations: Yes: [all per litter]
- Soft tissue examinations: Yes: [half per litter]
- Skeletal examinations: Yes: [half per litter] - Statistics:
- - Comparison of malformation and variation rates was carried out using R.A. Fisher’s exact test (p ≤ 0.05).
- Homogeneity of variances was tested by the Bartlett chi-square test followed by a one-way analysis of variance (ANOVA).
- When the results indicated a significant difference among groups Dunnett test (p ≤ 0.01) was used to compare the experimental groups with the control group. - Indices:
- - Resorption rate in % = (Resorptions / implantations) X 100
- Malformation rate in % = (malformed fetuses / fetuses) X 100
- Variation rate in % = (fetuses with variations / fetuses) X 100
- Pre-implantation loss in % = (corpora lutea-implantations / corpora lutea) X 100
- Post-implantation loss in % = (implantations-living fetuses / implantations) X 100
- Conception rate in % = (number of pregnant animals / number of animals mated) X 100 - Historical control data:
- Yes; summarized results of teratology studies in Sprague-Dawley rats (1988-1991) were attached as Appendix-4 to the study
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
- Mortality: No treatment-related mortality was observed.
- Clinical symptoms: At 1000 mg/kg bw/day, 6/20 dams showed reduced motor activity and salivation after first dosing, two of them salivation after second dosing. The reactions occurred within 5-20 minutes after administration and lasted for 20-60 minutes, 1-2 hours or 2-6 hours. No clinical signs were observed in the remaining high-dosed and the low-dosed dams.
- Body weight, body weight change: Body weights remained within the normal range, body weight gain showed no influence of the test material.
- Food consumption: Transient impairment of the food consumption by the highest tested dose (1000 mg/kg bw/day) was observed on the 7th, 8th and 9th gestation day by 6%, 22% and 10%, respectively. Food consumption had normalised from the 10th gestation day onwards.
- Drinking-water consumption: Treatment did not influence drinking-water consumption.
- Autopsy findings: No treatment-related pathological changes were detected at autopsy.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
- Mortality: No dead fetuses observed in control or treatment groups.
- Uterus and placentae weights, conception rate, mean number of corpora lutea and implantation sites, pre-implantation loss and number of viable fetuses, sex distribution of fetuses and weight of fetuses: No treatment-related effects
- Number of resorptions and consequently the post-implantation loss: Slightly but not significantly (at p ≤ 0.01) increased at 1000 mg/kg bw/day
- External macroscopic examination: No treatment-related effects; one malformed fetus at 1000 mg/kg bw/day (shifted and fused dorsal, lumbar and coccygeal vertebrae, bilateral crossed legs, stump tail, omphalocele) belongs to the spontaneous range as to type and number of affected fetuses (control: one fetus with stump tail)
- Soft tissue examination: No treatment-related effects; very common variations (uni- or bilateral dilated renal pelvis, haemorrhages of the liver, 4th cerebral ventricle enlarged) were observed in all groups without any dose-response relationships
- Skeletal examination: No treatment-related effects; variations (accessory 14th ribs, wavy ribs and bipartite/misaligned sternum) were observed in all groups and/or retardations (incomplete or missing ossification of hyoid, skull, vertebral bodies and/or sternebrae) were found biologically non-significant
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: Examination of the influence on the pregnant rat and the fetus by oral administration summary of maternal clinical symptoms
|
Test Group 1: Control |
Test Group 2: 250 mg/kg bw/day |
Test Group 3: 1000 mg/kg bw/day |
|
Dams evaluated |
n = |
20 |
20 |
22# |
No remarkable observations |
n = |
20 |
20 |
14 |
% |
100 |
100 |
63.6 |
|
Reduced motility |
n = |
0 |
0 |
6 |
% |
0 |
0 |
27.3 |
|
Salivation |
n = |
0 |
0 |
7 |
% |
0 |
0 |
31.8 |
|
Opisthotonus |
n = |
0 |
0 |
1* |
% |
0 |
0 |
4.5 |
|
Tonoclonic convulsions |
n = |
0 |
0 |
1** |
% |
0 |
0 |
4.5 |
* deceased dam no. 53; ** * deceased dam no. 56; # dams no. 53, 56 died prematurely due to regurgitation and aspiration of the test substance
Applicant's summary and conclusion
- Conclusions:
- In conclusion, the no-observed-effect level (NOEL) for maternal and fetotoxicity of camphene administered orally (gavage) was considered to be 250 mg/kg bw/day in Sprague-Dawley rats. Further, camphene is not considered to be teratogenic.
- Executive summary:
In a prenatal developmental toxicity study performed in accordance with OECD guideline 414 and in compliance with GLP, camphene in sesame oil was administered through gavage to groups of Sprague-Dawley pregnant rats (20/dose) at dose levels of 0 (vehicle control), 250 and 1000 mg/kg bw/day from Day 6 to 15 of pregnancy. Dams were observed twice daily for behaviour, external appearance, mortality and faeces. Body weights, food and water consumption were noted daily. Caesarean sections were performed on Day 20 of pregnancy and the ovaries and uterine contents were recorded. Fetuses were weighed and examined for external, visceral and skeletal malformations.
No treatment-related mortality was observed at any dose level. At 1000 mg/kg bw/day, 6/20 dams showed reduced motor activity and salivation after first dosing, two of them salivation after second dosing. The reactions occurred within 5-20 minutes after administration and lasted for 20-60 minutes, 1-2 hours or 2-6 hours. Body weights remained within the normal range and body weight gain showed no influence of the test material. Transient impairment of the food consumption by the highest tested dose (1000 mg/kg bw/day) was observed on the 7th, 8th and 9th gestation day by 6%, 22% and 10%, respectively. Treatment did not influence drinking-water consumption. No treatment-related pathological changes were detected at autopsy. No dead fetuses observed in control or treatment groups. No treatment-related effects were observed on uterus and placentae weights, conception rate, mean number of corpora lutea and implantation sites, pre-implantation loss and number of viable fetuses, sex distribution of fetuses and weight of fetuses. External macroscopic examination, examination of soft tissue and skeletal examination revealed no treatment-related biologically and/or statistically significant variations/retardations. Number of resorptions and consequently the post-implantation loss were increased slightly (statistically non- significant) at 1000 mg/kg bw/day.
In conclusion, the no-observed-effect level (NOEL) for maternal and fetotoxicity of camphene administered orally (gavage) was considered to be 250 mg/kg bw/day in Sprague-Dawley rats. Therefore, camphene is not considered to be teratogenic.
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