Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 416-210-4 | CAS number: 128119-70-0
- 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
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The experimental phase of the study was undertaken between 4 March and 18 March 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
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 (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 416-210-4
- EC Name:
- -
- Cas Number:
- 128119-70-0
- Molecular formula:
- C14H26O2
- IUPAC Name:
- 2-methyl-3-({1,7,7-trimethylbicyclo[2.2.1]heptan-2-yl}oxy)propan-1-ol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Equal numbers of healthy male and female CD rats of Sprague-Dawley origin (Hsd/Ola:SpragueDawley (CD) were obtained from a reputable supplier.
- They were in the weight range of 220 to 283 g and approximately seven to ten weeks of age prior to dosing (Day 1).
- All the rats were acclimatised to the experimental environment for a period of fourteen days prior to the start of the study.
- The rats were allocated without conscious bias to cages within the treatment group. They were housed individually in metal cages with wire mesh floors in Building R 14 Room 6.
- A standard laboratory rodent diet (Biosure LAD 1) and drinking water were provided ad libitum.
- Each batch of diet used for the study was analysed for certain nutrients, possible contaminants and micro-organisms.
- Results of routine physical and chemical examination of drinking water at source as conducted, usually weekly by the supplier are made available to Huntingdon Research Centre Ltd. (as quarterly summaries).
- The mean daily minimum and maximum temperatures of the animal room were 20°C and 22°C respectively and the mean daily relative humidity value was 49% R.H. Air exchange was maintained at 10 to 15 air changes per hour and lighting was controlled by means of a time switch to provide 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- A group of ten rats (five males and five females) was treated at 2.0 g/kg bodyweight. One day prior to treatment hair was removed from the dorso-Iumbar region of each rat with electric clippers exposing an area equivalent to approximately 10 % of the total body surface. The test substance was applied by spreading it evenly over the prepared skin. The treated area (approximately 50 mm x 50 mm) was then promptly covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk. At the end of the 24 hours exposure period, the dressings were carefully removed and the treated area of skin was washed with warm (30° to 40°C) water and blotted dry with absorbent paper. The day of dosing was designated Day 1.
- Duration of exposure:
- 24 hours
- Doses:
- 2.05 ml/kg (specific gravity 0.975)
- No. of animals per sex per dose:
- A group of ten rats (five males and five females)
- Control animals:
- no
- Details on study design:
- OBSERVATIONS
- Mortality: Cages of rats were checked at least twice daily for any mortalities.
- Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of seven hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day. This latter observation was at approximately 16.30 hours on week daysor 11.30 hours on Saturdays and Sundays. The nature and severity of the clinical signs and time were recorded at each observation.
- All animals were observed for 14 days after dosing.
Dermal responses: Local dermal irritation at the treatment site was assessed daily using the following numerical system:
- Erythema and eschar formation: No erythema: 0; Slight erythema: 1; Well-defined erythema: 2; Moderate erythema: 3; Severe erythema (beet redness) to slight: 4; eschar formation (injuries in depth): 5
- Oedema formation: No oedema: 0; Slight oedema: 1; Well-defined oedema (edges of area well-defined by definite raising): 2; Moderate oedema (raised approximately 1 millimetre): 3; Severe oedema (raised more than 1 millimetre& extending beyond the area of exposure): 4
- Bodyweight: Individual bodyweights were recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes were calculated.
- Macroscopic examination: All animals were killed on Day 15 by cervical dislocation and were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all examined tissues was recorded.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths folIowing a single dermal application of Bornafix at 2.0 g/kg bodyweight.
- Clinical signs:
- other: There were no signs of systemic reaction to treatment.
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed on Day 15.
- Other findings:
- DERMAL RESPONSES
Slight erythema with no oedema was observed at the sites of application of the test substance for all rats on Day 2 and in females only on Days 3 and 4.
There were no other dermal changes and irritation had resolved by either Day 3 (males) or Day 5 (females). for full details please see table 1
Any other information on results incl. tables
Table 1 Dermal reactions observed after application of Bornafix
Dose g/kg |
Sex |
Animal number & ear mark |
E = Erythema O = Oedema |
Day |
|||
2 |
3 |
4 |
5 To 15 |
||||
2 |
M A L E
|
1 RP |
E |
1 |
0 |
0 |
0 |
O |
0 |
0 |
0 |
0 |
|||
2 LP |
E |
1 |
0 |
0 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
3 RLP |
E |
1 |
0 |
0 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
4 RIRO |
E |
1 |
0 |
0 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
5 LILO |
E |
1 |
0 |
0 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
F E M A I L
|
6 RP |
E |
1 |
1 |
1 |
0 |
|
O |
0 |
0 |
0 |
0 |
|||
7 LP |
E |
1 |
1 |
1 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
8 RPLP |
E |
1 |
1 |
1 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
9 RIRO |
E |
1 |
1 |
1 |
0 |
||
O |
0 |
0 |
0 |
0 |
|||
10 LILO |
E |
1 |
1 |
1 |
0 |
||
O |
0 |
0 |
0 |
0 |
Table 2 Individual bodyweights (g) of rats dosed dermally with Bornafix
Sex |
Dose g/kg |
Animal number & ear mark |
Bodyweight (g) at |
||
Day 1 |
Day 8 |
Day 15 |
|||
M A L E
|
2.0 |
1 RP |
269 |
314 |
370 |
2 LP |
261 |
293 |
332 |
||
3 RPLP |
264 |
298 |
354 |
||
4 RIRO |
283 |
315 |
367 |
||
5 LILO |
277 |
309 |
360 |
||
F E M A I L
|
2.0 |
6 RP |
236 |
242 |
251 |
7 LP |
241 |
255 |
272 |
||
8 RPLP |
245 |
255 |
261 |
||
9 RIRO |
220 |
230 |
244 |
||
10 LILO |
252 |
263 |
290 |
Table 3 Individual bodyweight changes (g) of rats dosed dermally with Bornafix
Sex |
Dose g/kg |
Animal number & ear mark |
Bodyweight gains (g) at |
|
Week 1 |
Week 2 |
|||
M A L E
|
2.0 |
1 RP |
45 |
56 |
2 LP |
32 |
39 |
||
3 RPLP |
34 |
56 |
||
4 RIRO |
32 |
52 |
||
5 LILO |
32 |
51 |
||
F E M A I L
|
2.0 |
6 RP |
6 |
9 |
7 LP |
14 |
17 |
||
8 RPLP |
10 |
6 |
||
9 RIRO |
10 |
14 |
||
10 LILO |
11 |
27 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not harmful in accordance with EU CLP (EC No 1272/2008 and its amendments)
- Conclusions:
- In an acute dermal toxicity test in male and female rats, an LD50 of > 2000 mg/kg bw was determined.
- Executive summary:
A study according to OECD 402 was performed to assess the acute dermal toxicity of Bornafix to the rat. A group of ten rats (five males and five females) was given a single occlusive dermal application of the test substance, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period. There were no deaths and no signs of systemic reaction to treatment. Slight erythema with no oedema was observed at the sites of application of the test substance for all rats on Day 2 and in females only on Days 3 and 4. There were no other dermal changes and irritation had resolved by either Day 3 (males) or Day 5 (females). Slightly low bodyweight gains were recorded for four males and four females on Day 8 and in one male and two females on Day 15; the remaining rats achieved anticipated gains on Day 15. All other rats achieved anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15. The acute lethal dermal dose to rats of Bornafix was found to be greater than 2.0 g/kg bodyweight.
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.