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EC number: 253-775-4 | CAS number: 38083-17-9
- 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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Endpoint summary
Administrative data
Description of key information
Acute toxicity studies with crinipan were performed in rats (study report: Bayer/Symrise 1975039), mice (study report: Bayer/Symrise 1975038), rabbits (study report: Bayer/Symrise 1975040), and dogs (study report: Bayer/Symrise 1975039). The results clearly classify crinipan as moderately toxic with oral LD50 of 400 mg/kg bw in rats. Accordingly, the compound is classified into ‘Category 4’ according to the current EU-CLP.
No study on the acute toxicity of crinipan upon dermal application was conducted. This is considered justified, since no local corrosive or irritant effects on the skin were observed after topical application of crinipan (see the corrosion/irritation section of this Technical Dossier for details), the dermal absorption of crinipan is low (see the corrosion/irritation section of this Technical Dossier for details), and crinipan is only moderately toxic following oral application (e.g., the LD50 value of crinipan in rats was determined at 400 mg/kg; see the studies on acute oral toxicity documented in this Technical Dossier for details). Accordingly, it is considered unlikely that crinipan might elicit any noteworthy degree of local or systemic toxicity following dermal application, in particular as pharmacokinetic studies showed only limited dermal penetration.
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
- Study period:
- No study period specified, but the study report was finalized on 1975-01-08.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a method that is largely comparable to the current OECD guideline 401. However, it was not conducted according to the principles of GLP, as GLP had not yet been implemented at the time the study was performed.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- The test item was administered orally to groups of 10 male and female Wistar rats at dose levels of 160, 200, 250, 320, 400, 500, 630, 800, and 1000 mg/kg. Toxicity symptoms and mortality rates were recorded for a 14-d observation period. Animals that died were, whenever possible, autopsied and examined for pathological changes. The surviving rats were killed at the end of the trial and also autopsied. Computation of the LD50 values, with a confidence range of p = 0.05 was carried out by means of programmed probit analysis.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder Winkelmann (Kirchborchen, Germany)
- Weight at study initiation: 170-253 g
- Housing: Animals were kept in Makrolon cages type I or type III in groups of 5 animals per cage.
- Diet: standard diet (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: about 24°C - Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous solution with 5% cremophor
- Details on oral exposure:
- The test item was suspended in tap water with the addition of 5% cremophor and was administered to the animals in a volume of 10 mL/kg via a stomach tube.
- Doses:
- The test item was administered at dose levels of 160, 200, 250, 320, 400, 500, 630, 800, and 1000 mg/kg.
- No. of animals per sex per dose:
- 10 animals were used per dose (no data on animals per sex given).
- Control animals:
- not specified
- Details on study design:
- Toxicity symptoms and mortality rates were recorded for a 14-d observation period. Animals that died were, whenever possible, autopsied and examined for pathological changes. The surviving rats were killed at the end of the trial and also autopsied.
- Statistics:
- Computation of the LD50 values, with a confidence range of p=0.05 was carried out by means of the programmed probit analysis according to Fink and Hund [Fink H, Hund G (1965) Probitanalyse mittels programmgesteuerter Rechenanlagen. Arzneim-Forsch / Drug Res 15:624-630].
- Preliminary study:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 400 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 334 - 481
- Mortality:
- See table 1 in section "Any other information on results incl. tables".
- Clinical signs:
- other: Except for the dose of 160 mg/kg, which was symptom-free tolerated, all animals showed coordination disturbances and tonic-clonic convulsions about 1 h after administration. After 2 h, motility was reduced and the animals were temporarily laying on their
- Gross pathology:
- The autopsies did not provide any pathological findings.
- Other findings:
- no data
- Interpretation of results:
- moderately toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Crinipan was found to be moderately toxic upon a single oral administration to male and female rats.
- Executive summary:
The acute toxicity of crinipan upon oral administration was studied in male and female Wistar rats (n=10 per dose). Crinipan was found to be moderately toxic, with a LD50 of 400 mg/kg.
Reference
Table 1: Acute oral toxicty of crinipan in rats
Dose |
Number of animals used |
Toxicological result |
|
Number of animals that died |
Number of animals showing toxic symptoms |
||
160 |
10 |
0 |
0 |
200 |
10 |
1 |
10 |
250 |
10 |
2 |
10 |
320 |
10 |
5 |
10 |
400 |
10 |
5 |
10 |
500 |
10 |
7 |
10 |
630 |
10 |
6 |
10 |
800 |
10 |
9 |
10 |
1000 |
10 |
10 |
10 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 400 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity studies with crinipan were performed in rats (study report: Bayer/Symrise 1975039), mice (study report: Bayer/Symrise 1975038), rabbits (study report: Bayer/Symrise 1975040), and dogs (study report: Bayer/Symrise 1975039). The calculated oral LD50 are summarized in the following table.
Species |
Oral LD50 |
Number of animals / dose level |
Test guideline |
Remarks |
Wistar rats |
400 |
10 males |
Comparable to OECD 401 before GLP |
OECD 401 has been deleted, however the results are reliable and indicate crinipan as moderately toxic in all species |
CF1/W 86 mice |
644 |
10 males |
||
Giant Chinchilla rabbits |
250 |
2 females |
||
Beagle dogs |
250-500 |
2 animals |
The results mentioned above clearly classify crinipan as moderately toxic with oral LD50of 400 mg/kg bw in rats.
Justification for selection of acute toxicity – oral endpoint
The study was a good and reliable study conducted according to a
method that is largely comparable to the current OECD guideline 401.
Justification for classification or non-classification
Due to the findings described above (LD50 oral in rats 400 mg/kg bw) the substance has to be classified as Acute toxicity category 4, H302: Harmful if swallowed according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
It can reasonably be deduced that the substance does not exert systemic toxic effects after dermal application and thus does not have to be classified, because
- the substance has an LD50 400 mg/kg after administration of a single oral dose,
- and the dermal bioavailability of the substance is very low and was determined with a maximum value of 3.5% during 24 hours. It can thus be concluded that not enough substance would be systemically available upon dermal exposure to reach levels that could exert lethal effects.
No conclusion on classification and labeling regarding acute inhalation exposure can be derived due to lack of data.
The substance does not have to be classified forspecific target organ toxicity– single exposure according to Regulation (EC) No 1272/2008, as no specific toxic effects were observed after acute exposure.
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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