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EC number: 203-696-6 | CAS number: 109-69-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Reference Type:
- secondary source
- Title:
- 1-chlorobutane, CAS No. 109-69-3
- Author:
- OECD SIDS
- Year:
- 1 997
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 6
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline For Testing Of Chemicals, Preliminary Reproduction Toxicity Screening Test
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Nihon Bioreseach Center Inc., Hashima Laboratory, Hashima, Japan
- Limit test:
- no
Test material
- Reference substance name:
- 1-chlorobutane
- EC Number:
- 203-696-6
- EC Name:
- 1-chlorobutane
- Cas Number:
- 109-69-3
- Molecular formula:
- C4H9Cl
- IUPAC Name:
- 1-chlorobutane
- Details on test material:
- - Name of test material (as cited in study report): 1-Chlorobutane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: females: ~230 g; males: ~340 g
- Housing: stainless steel and plastic cages
- Diet (ad libitum): solid pellets (CRF-1, Oriental Yeast Co. Ltd.)
- Water (ad libitum): tap water
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 0, 0.048, 0.24, 1.2, 6%
- Amount of vehicle (if gavage): max. 5 mL/kg/bw
- Lot/batch no.: 5233 and 8250 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability of test solutions were confirmed 1 and 3 hours after preparation of doses.
- Details on mating procedure:
- Mating was performed in hanging stainless steel cages.
- Duration of treatment / exposure:
- males: 49 days
females: 41-46 days - Frequency of treatment:
- once daily
- Duration of test:
- males: 49 days
females: 41-46 days (from 14 days before mating to day 3 of lactation)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2.4, 12, 60, 300 mg/kg bw/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Preliminary study with male rats was conducted. Dose levels: 0, 10, 30, 100, 300, 1000 mg/kg bw/d
Within 5 days all animals of the top dose died. Salivation was observed 3 days after treatment in group 300 mg/kg, 7 days after treatment in group 100 mg/kg bw/d. Actual concentrations were selected on the basis of these results.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations: general conditions and mortality
BODY WEIGHT: Yes
- Time schedule for examinations: twice a week
FOOD CONSUMPTION: Yes
twice a week (converted to a daily dose measured over two consecutive days)
POST-MORTEM EXAMINATIONS: Yes
- Organs examined: testes, epididymes, ovaries, stomach, small intestine
OTHER:
reproductive indices - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data - Fetal examinations:
- - External examinations: Yes: number of dead pups at day 0 and 4, body weight at day 0 and 4, necropsy findings on day 4
- Statistics:
- Bartlett-test, Dunnet-test, Scheffe-test, χ2-test
- Indices:
- gestation index, delivery index, birth index, viability index
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Details on maternal toxic effects:
CLINICAL SIGNS AND MORTALITY (PARENTAL ANIMALS)
males:
- salivation in all dose groups
females:
- salivation: before and during mating in animals receiving 60 and 300 mg/kg bw/d, during pregnancy in animals receiving 12 mg/kg bw/d - 300 mg/kg bw/d and during lactation in highest dose females (300 mg/kg bw/d)
- One dam died on day 22 of pregnancy and one dam died on day 4 of lactation in the 300 mg/kg bw/d group.
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
- statistically significant suppressed body weight gain in males and females of the 300 mg/kg bw/d dose group
- reduced food consumption in males and females receiving 300 mg/kg bw/d
GROSS PATHOLOGY (PARENTAL ANIMALS)
- surviving females on day 4 of lactation: 12/12 controls, 12/12 animals of 2.4 mg/kg bw/day, 11/11 animals of 12 mg/kg bw/day, 10/10 animals of 60 mg/kg bw/day and 5/9 animals of 300 mg/kg bw/day did not show necropsy findings. At a dose of 300 mg/kg bw/day the following effects were observed: in two of 9 animals white glandular mucosa of the stomach, in 1 of 9 animals each dark red spots, black spots and edema in the glandular mucosa of the stomach, in 1 of 9 animals black discoloration of the small intestine
- males: no necropsy findings
HISTOPATHOLOGY (PARENTAL ANIMALS)
females: histopathological examinations of the ovary in the other dose groups of n-butyl chloride except 300 mg/kg bw/day group were not carried out. No remarkable changes were recognized in the ovary.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 2.4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 2.4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
MORTALITY (OFFSPRING):
- Control: 2 pups from 2 dams until day 4 of lactation
- 2.4 mg/kg bw/d: 3 pups from 2 dams until day 4 of lactation; the survival rate of pups was the same as control.
- 12 mg/kg bw/d: 1 pup from a dam, all pups on day 2 of lactation from a dam (No. 251) which didn’t take care of pups (maternal toxicity); The survival rate of pups tended to be decreased slightly.
- 60 mg/kg bw/d: 5 pups from 4 dams, all pups on day 2 of lactation from a dam (No. 356) which didn’t take care of pups (maternal toxicity); The survival rate of pups tended to be decreased slightly.
- 300 mg/kg bw/d: 3 pups from 2 dams, 8 pups from a dam (No. 456) which died on day 4 of lactation, 15 pups from a dam (No. 459) which showed decrease of food consumption and didn’t take care of pups and lost weight significantly on day 4 of lactation (maternal toxicity); The survival rate of pups was decreased but not statistically significant.
BODY WEIGHT (OFFSPRING):
depression of body weight gain in the highest dose group on day 4 of lactation (males: control 10.19 +/- 1.45 g, 300 mg/kg bw/d 8.19 +/- 2.18 g; females: control 9.47 +/- 1.47 g, 300 mg/kg bw/d 7.77 +/- 1.85 g); no changes in body weight in all dose groups compared to the control group on day 0 of lactation.
GROSS PATHOLOGY (OFFSPRING):
no remarkable changes in necropsy in pups on day 4 of lactation
The decreased survival rate of pups in the 12, 60 and 300 mg/kg bw/d dose group was clearly due to maternal toxicity resulting in lack of pup care behaviour and subsequently in mortality of pups. No remarkable changes at gross necropsy were observed in pups even in the highest dose group confirming, that maternal toxicity is the cause for the reduced viability index on day 4 of lactation.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Observation of pups (F1)
Group [mg/kg bw/d] |
Control |
n-butyl chloride |
|||
0 |
2.4 |
12 |
60 |
300 |
|
Number of dams |
12 |
12 |
12 |
11 |
11 |
Number of implantation scars total |
190 |
200 |
214 |
189 |
197 (12) |
Number of implantation scars per dam |
15.8 +/- 3.6 |
16.7 +/- 2.1 |
17.8 +/- 1.3 |
17.2 +/- 2.0 |
16.4 +/- 2.1 (12) |
Gestation index (%) |
100 |
100 |
100 |
100 |
91.7 (12) |
Numer of live pups born total |
172 |
180 |
198 |
169 |
164 |
Numer of live pups born per dam |
14.3 +/- 3.7 |
15.0 +/-2.0 |
16.5 +/- 1.6 |
15.4 +/-3.6 |
14.9 +/- 2.0 |
Number of dead pups on day 0 total |
7 |
4 |
1 |
4 |
1 |
Number of dead pups on day 0 per dam |
0.6 +/- 0.9 |
0.3 +/- 0 0.5 |
0.1 +/- 0.3 |
0.4 +/- 0.5 |
0.1 +/- 0.3 |
Birth index (%) |
90.8 +/- 11.0 |
90.2 +/- 7.5 |
92.4 +/- 5.5 |
88.5 +/- 15.7 |
92.4 +/- 6.0 |
Number of dead pups on day 4 total |
170 |
177 |
181 |
146 |
138 |
Viability index (%) |
99.0 +/- 2.3 |
98.3 +/- 4.0 |
91.2 +/- 28.8 |
88.2 +/- 29.5 |
85.7 +/- 28.6 |
Number of external abnormalities |
0 |
0 |
0 |
0 |
0 |
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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