Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-998-8 | CAS number: 112-70-9
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from handbook
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Reproductive and developmental toxicity study of test material was performed on the rats
- Author:
- John Wiley & Sons
- Year:
- 2 012
- Bibliographic source:
- Patty's Toxicology
- Reference Type:
- other: secondary source
- Title:
- SIDS Initial Assessment Report
- Author:
- OECD SIDS
- Year:
- 2 006
- Bibliographic source:
- SIDS Initial Assessment Report,2006
- Reference Type:
- other: authoritative database
- Title:
- Reproductive and developmental toxicity study of test material
- Author:
- HSDB
- Year:
- 2 019
- Bibliographic source:
- U.S. National Library of Medicine
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Reproductive and developmental toxicity study of test material was performed on the rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Hexan-1-ol
- EC Number:
- 203-852-3
- EC Name:
- Hexan-1-ol
- Cas Number:
- 111-27-3
- Molecular formula:
- C6H14O
- IUPAC Name:
- hexan-1-ol
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): hexan-1-ol
- Molecular Formula:C6H14O
- Molecular Weight: 102.1756 g/mol
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: COBS CD
- Details on species / strain selection:
- No data available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test material diluted with corn oil - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 days (from days 6-15 of gestation)
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0,200,1000mg/kg bw
- No. of animals per sex per dose:
- Total:75
0 mg/kgbw/day:25 female
200 mg/kgbw/day:25 female
1000 mg/kgbw/day:25 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: Yes
- Time schedule : daily
- Cage side observations checked in table [No.?] were included. No data available
DETAILED CLINICAL OBSERVATIONS: No data available
- Time schedule: No data available
BODY WEIGHT: Yes
- Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OTHER: No data available - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- Intrauterine survival, foetal weight and external, skeletal and visceral anomalies were recorded.
- Postmortem examinations (parental animals):
- Post-mortem examinations (Parent Animal)
SACRIFICE
The dams were sacrificed and sectioned on gestation day 20
GROSS NECROPSY:yes - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- foetal weight and external, skeletal and visceral anomalies were recorded.
HISTOPATHOLOGY / ORGAN WEIGTHS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. - Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- clinical signs of intoxication were observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced body weight was observed at 1000mg/kg bw dose group
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- body weight and weight gain
- reproductive performance
- Remarks on result:
- other: overall no toxic effects was observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Effects on the foetus were confined to an increase in numbers of litters with the skeletal variant 'malaligned sternebrae' which occured at 200 mg/kg/day only and a slight decrease in foetal weight at 1000 mg/kg/day which was within the historical control range. As an increased incidence of 'malaligned sternebrae' was not observed at 1000 mg/kg/day the observation at 200 mg/kg/day was considered incidental.
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- gross pathology
- Remarks on result:
- other: No developmental toxic effects was observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The no observed adverse effect level (NOAEL) was considered to be 1000mg/kg bw/day for reproductive and developmental toxicity .When female rats were treated with test material by orally during gestation days 6-15.
- Executive summary:
The reproductive and developmental toxicity study of test material was performed in female COBS CD rats. The test material was dissolved in corn oil and administered in dose concentration 0,200,1000mg/kg bw by oral gavage route from days 6-15 of gestation. 25 females /dose group were used in study. All the animals were observed forClinical signs, body weight and food consumoption.The dams were sacrificed and sectioned on gestation day 20. Intrauterine survival, foetal weight and external, skeletal and visceral anomalies were recorded. In dams clinical signs of intoxication were observed also reduced body weight was observed at 1000mg/kg bw dose group. Effects on the foetus were confined to an increase in numbers of litters with the skeletal variant 'malaligned sternebrae' which occurred at 200 mg/kg/day only and a slight decrease in foetal weight at 1000 mg/kg/day which was within the historical control range. As an increased incidence of 'malaligned sternebrae' was not observed at 1000 mg/kg/day the observation at 200 mg/kg/day was considered incidental. Hence the no observed adverse effect level (NOAEL) was considered to be 1000mg/kg bw/day for reproductive and developmental toxicity .When female rats were treated with test material by orally during gestation days 6-15.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
