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EC number: 203-700-6 | CAS number: 109-74-0
- 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
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- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted at a GLP facility under OECD guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Butyronitrile
- EC Number:
- 203-700-6
- EC Name:
- Butyronitrile
- Cas Number:
- 109-74-0
- Molecular formula:
- C4H7N
- IUPAC Name:
- butanenitrile
- Details on test material:
- Sponsor's identification: N-butyronitrile
Description: clear colourless liquid
Batch number: TXTXOL
Purity: 99.891%
Date received: 30 September 2012
Expiry date: not supplied
Storage conditions: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and five female Wistar (RccHan™:WIST) strain rats were supplied by Harlan
Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to
cages. The females were nulliparous and non-pregnant. After an acclimatisation period
of at least five days the animals were selected at random and given a number unique
within the study by indelible ink-marking on the tail and a number written on a cage card.
At the start of the study the animals weighed at least 200 g, and were eight to twelve
weeks of age.
The animals were housed in suspended solid-floor polypropylene cages furnished with
woodflakes. The animals were housed individually during the 24-Hour exposure period
and in groups of up to four, by sex, for the remainder of the study. Free access to mains
drinking water and food (2014C Teklad Global Rodent diet supplied by Harlan
Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking
water and bedding were routinely analysed and were considered not to contain any
contaminants that could reasonably be expected to affect the purpose or integrity of the
study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to
70% respectively. Any occasional deviations from these targets were considered not to
have affected the purpose or integrity of the study. The rate of air exchange was at least
fifteen changes per hour and the lighting was controlled by a time switch to give twelve
hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered
not to contain any contaminant of a level that might have affected the purpose or integrity
of the study.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- For each animal the calculated volume of test item was applied as evenly as possible to
an area of shorn skin (approximately 10% of the total body surface area) using a
graduated syringe. A piece of surgical gauze was placed over the treatment area and
semi-occluded with a piece of self-adhesive bandage. The animals were caged
individually for the 24-Hour exposure period and for the remainder of the test. Shortly
after dosing the dressings were examined to ensure that they were securely in place.
After the 24-Hour contact period the bandage was carefully removed and the treated skin
and surrounding hair wiped with cotton wool moistened with distilled water to remove any
residual test item. - Duration of exposure:
- 24 hours
- Doses:
- 500, 1000 or 2000 mg/kg
- No. of animals per sex per dose:
- 1 for the rangefinding study and 4 for the limit test.
- Control animals:
- no
- Details on study design:
- On the day before treatment the back and flanks of each animal were clipped free of hair. Using available information on the toxicity of the test item, a single group of animals was initially treated as follows:
Dose Level Concentration Dose Volume Number of Rats
(mg/kg) (ml/kg) Male/Female
======================================
500 50 10 1/1
In the absence of mortality at a dose level of 500 mg/kg, an additional group of animals was
treated as follows:
Dose Level Concentration Dose Volume Number of Rats
(mg/kg) (ml/kg) Male/Female
======================================
1000 0.778 1.27 1/1
In the absence of mortality at a dose level of 1000 mg/kg, an additional group of animals
was treated as follows:
Dose Level Concentration Dose Volume Number of Rats
(mg/kg) (ml/kg) Male/Female
======================================
2000 0.778 2.54 1/1
In the absence of mortality at a dose level of 2000 mg/kg, an additional group of animals
was treated as follows:
Dose Level Concentration Dose Volume Number of Rats
(mg/kg) (ml/kg) Male/Female
======================================
2000 0.778 2.54 1/1
A total of ten animals were therefore treated at a dose level of 2000 mg/kg in the study.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: Red/brown staining around the eyes or snout was noted in the male treated at a dose level of 1000 mg/kg and three animals treated at a dose level of 2000 mg/kg. There were no signs of systemic toxicity noted in the remaining animals
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The acute dermal median lethal dose (LDso) of the test item in the Wistar strain rat was
found to be greater than 2000 mg/kg bodyweight - Executive summary:
The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following: OECD Guidelines for the Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987) ; Method 83 Acute Toxicity (Dermal) of Commission Regulation (EC) No. 440/2008. Initially, three groups, each of two animals (one male and one female), were given single, 24 hour, semi-occluded dermal applications of the test item to intact skin at dose levels of 500, 1000 or 2000 mg/kg bodyweight. Based on the results of the initial test a further group of eight animals (four males and four females) was similarly treated with the undiluted test item at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths. Red/brown staining around the eyes or snout was noted in the male treated at a dose level of 1000 mg/kg and three animals treated at a dose level of 2000 mg/kg. There were no signs of systemic toxicity noted in the remaining animals. Very slight erythema was noted at the test site of the female treated at a dose level of 500 mg/kg. There were no signs of dermal irritation noted in the remaining animals. One animal treated at a dose level of 1000 mg/kg and five animals treated at a dose level of 2000 mg/kg showed bodyweight loss during the first week but expected gain in bodyweight during the second week. The remaining animals showed expected gains in bodyweight over the study period. Necropsy. No abnormalities were noted at necropsy. Conclusion. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
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