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EC number: 613-782-9 | CAS number: 65355-32-0
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-02-12 to 2002-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 02-1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 07-1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (1r,1's,4r,4'r)-4'-propyl-[1,1'-bi(cyclohexane)]-4-carboxylic acid
- EC Number:
- 613-782-9
- Cas Number:
- 65355-32-0
- Molecular formula:
- C16 H28 O2
- IUPAC Name:
- (1r,1's,4r,4'r)-4'-propyl-[1,1'-bi(cyclohexane)]-4-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne, France
- Age at study initiation: 11 weeks (male) and 8-9 weeks (female)
- Weight at study initiation: 2.21 - 2.47 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood, and haysticks for gnawing
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: Days 1 to 7
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A single application of 100 mg into the conjunctival sac of the left eye
- Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 7 days;
Viability/mortality: daily from delivery of the animals to the termination of the test;
Clinical signs: Daily from delivery of the animals to the termination of the test;
Body weights: At start of acclimatization, on the day of application and at termination of observation;
Irritation scores: 1, 24, 48, and 72 hours, as well as 7 days after treatment - Number of animals or in vitro replicates:
- 2 females and 1 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes were not rinsed after instillation
- Time after start of exposure: 7 days
SCORING SYSTEM: The occular reaction was assessed according to the numerical scoring system listed in the EU Regulation (EC) No 1272/2008 (CLP), as amended for fifteenth time in Regulation (EU) No 2020/217, at approximately 1, 24, 48 and 72 hours as well as 7 days after application. When present, corrosion and/or staining of sclera and cornea by the test item were recorded and reported.
TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel/ Switzerland)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Application of the test item to healthy rabbit conjunctivae resulted in a primary eye irritation score of 1. No abnormal findings were observed in the cornea or iris of any animal at any of the measuring intervals (table 1). Slight to moderate reddening of the conjunctivae was observed in all animals 1 hour after treatment. Slight reddening continued to be observed in all animals but gradually diminished to clear at the 7-day reading (table 1). Swelling of the conjunctivae (slight with partial eversion of lids or with lids about half-closed) was apparent in all animals at the 1-hour reading. Swelling persisted in one animal up to 48 hours after treatment (table 1). Assessment of the sclera was not possible in one animal at the 1-hour reading due to swelling of the conjunctiva. Moderate reddening was, however, subsequently observed in this animal at the 24- and 48-hour readings but diminished to clear 7 days after treatment. Moderate reddening was similarly observed in the remaining two animals 1 hour after treatment but cleared in one animal at the 24-hour reading and in the other animal at the 48-hour reading (table 1). A slight to moderate waterly discharge was present in all animals 1 hour after treatment and a slight waterly discharge was still evident in one animal at the 24-hour reading. No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals. No corrosion of the cornea was observed at any of the reading times.
- Other effects:
- - Lesions and clinical observations: no clinical signs of systemic toxicty were observed in the animals during the study and no mortality occured
- white remnants of the test item were observed in the eye or conjunctival sac of all animals 1 hour after treatment and continued to be observed in one animal up to the 24-hour reading
Any other information on results incl. tables
Table 1: Eye irritation scores – individual values
Animal Number |
Sex |
Evaluation Interval |
Corneal Opacity |
Iris |
Conjunctivae |
Cumulative |
Sclera |
||
Redness |
Chemosis |
Score |
Mean |
||||||
4 |
M |
1 hour |
0 |
0 |
2 |
1 |
3 |
3.33 |
2 |
5 |
F |
0 |
0 |
1 |
3 |
4 |
n.a. |
||
6 |
F |
0 |
0 |
1 |
2 |
3 |
2 |
||
4 |
M |
24 hours |
0 |
0 |
1 |
0 |
1 |
1.67 |
1 |
5 |
F |
0 |
0 |
1 |
2 |
3 |
2 |
||
6 |
F |
0 |
0 |
1 |
0 |
1 |
0 |
||
4 |
M |
48 hours |
0 |
0 |
1 |
0 |
1 |
1 |
0 |
5 |
F |
0 |
0 |
1 |
1 |
2 |
2 |
||
6 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
||
4 |
M |
72 hours |
0 |
0 |
0 |
0 |
0 |
0.33 |
0 |
5 |
F |
0 |
0 |
1 |
0 |
1 |
1 |
||
6 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
||
4 |
M |
7 days |
0 |
0 |
0 |
0 |
0 |
0.00 |
0 |
5 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
||
6 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
n.a.= not assessable due to swelling of the conjunctivae
F= female
M=male
Table 2. Eye irritation scores – mean values after 24, 48 and 72 hours
Animal Number |
Sex |
Corneal Opacity |
n |
iris |
n |
Conjunctivae |
Primary Eye Irritation Score |
|||
redness |
n |
chemosis |
n |
|||||||
4 |
M |
0 |
3 |
0 |
3 |
0.67 |
3 |
0 |
3 |
1 |
5 |
F |
0 |
3 |
0 |
3 |
1 |
3 |
1 |
3 |
|
6 |
F |
0 |
3 |
0 |
3 |
0.33 |
3 |
0 |
3 |
|
Mean score |
0 |
|
0 |
|
0.67 |
|
0.33 |
|
|
n= number of available data points
Table 3. Eye irritation scores – assessment according to EEC guidelines
Evaluated intervals |
Corneal Opacity |
Iris |
Conjunctivae |
|
redness |
chemosis |
|||
24 hours |
Not irritating |
Not irritating |
Not irritating |
|
48 hours |
||||
72 hours |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not induce significant or irreversible damage to the rabbit eye and is considered to be "not irritating" to the rabbit eye.
- Executive summary:
The primary eye irritation of the test item was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7 days after test item application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary eye irritation score was calculated by totaling the mean cumulative scores at 24, 48 and 73 hours and then dividing the resulting total by the number of data points. The primary eye irritation score was 1.00 (max 13). The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.67 redness of the conjunctivae and grade 0.33 chemosis of the conjunctivae. The instillation of the test item into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and swelling. These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any reading. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. Based upon the referred classification criteria (EU Regulation (EC) No 1272/2008 (CLP), as amended for fifteenth time in Regulation (EU) No 2020/217), the test item is considered to be "not irritating" to the rabbit eye.
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