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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 218-524-5 | CAS number: 2172-33-0
- 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
Endpoint summary
Administrative data
Description of key information
The irritation capacity on the skin and eye of animals was intensivly tested in the past and numerous data with different test substance concentrations are available.
Skin irritation:
In total five different studies with different test material concentrations are available. In the latest study FAT 46014/F with a purity of about 36 % was investigated according to OECD 404 in the rabbit. Three animals have been tested for 4 hours on the intact and abraded skin under semiocclusive conditions. Taking the 24 h, 48 h and 72 h readings into account (mean value 0 for erythema and eschar formation and mean value 0 for edema formation) the test substance has to be judged as non-irritating. A second study investigating FAT 46014/E with a purity of 35 % in a pre-guideline study on abraded and intact skin areas under occlusive testing conditions resulted a mean of 1 for erythema/eschar formation and a mean of 1 for edema formation taking the 24 h, 48 h and 72 h readings of the intact skin areas into account. Interestingly abrasion does not lead to further elevation of scores compared with intact skin areas. A third study on FAT 46014/C with a purity of 18 % was performed in a pre-guideline test on the intact and abraded skin under occlusive conditions. Results obtained in 6 animals on intact skin areas resulted in mean values of 0.16 for erythema/eschar formation and 0.16 for edema formation with full recovery after 48 hours. Based on these results the substance has to be judged as not irritating to the skin. Notably, even slightly enhanced effects observed on abraded skin areas returned to normal 3 days after test substance application. In the fourth study FAT 46014/B with a purity of 45 % was investigated in a pre-guideline test in six rabbits. Again the test substance was applied to intact and abraded skin areas under occlusive conditions. Unfortunately, only readings 24 h and 72 h after test substance application have been reported. Nevertheless, the test substance showed no signs of irritation at all (all readings in all animals are zero) and no other effects are reported. Therefore, it is concluded that the test substance did not induce any signs of irritation to the animals. Last but not least a study has been performed on FAT 46014/A with a purity of 45 %. The test material was investigated in a pre-guideline study in six rabbits on intact and abraded skin areas under occlusive conditions. Also in this test only results from the 24 hour and 72 hour reading have been reported. But since all reading on the intact skin have been zero for erythema/eschar formation and edema formation and no other signs of toxicity or irritation effects have been noted the substance is judged to be not-irritating in this test. In summary it can be noted that in general all tests may be used for assessment of the irritation potential to the skin of rabbits since test substance application and terms of testing conditions are comparable or slightly elevated compared to today’s standards (occlusive vs. semiocclusive testing conditions; abrasive vs intact testing conditions). But since data are reported very detailed, some effects of elevated testing conditions might be judged separately. As an overall conclusion it can be noted that up the maximum substance concentration of 45 % the test substance has to be judged as non-irritant according to CLP.
Eye irritation:
In total five different studies with different test material concentrations are available. In the latest study FAT 46014/F with a purity of about 36 % was investigated according to OECD 405 in the rabbit. Three animals have been tested by instillation of 0.1 g into one eye while the other eye has been left untreated to serve as internal control. Rinsing of the eye has not been performed (as recommended by the guideline) representing an elevated testing condition. As a result, mean value for the cornea (24, 48 and 72 hour readings) is 1.2, mean value for the iris and mean values for the conjunctiva (24, 48 and 72 hour readings) are 1.9 for redness and 0.66 for chemosis. Taking these results into account the test substance has to be judged as irritating to the eye. A second study investigating FAT 46014/E with a purity of 35 % in a pre-guideline study in six rabbits. Instillation of 0.1 g of the test material into one eye was followed by a rinsing procedure after 30 seconds in 3 animals while in further 3 animals the test substance remained in the eye. Scoring of the animals after 24, 48 and 72 hours resulted in no scores neither for cornea, nor for iris nor for conjunctive (all scores reported, all scores zero). Based on these test results the substance was judged not-irritating to the eye. A third study on FAT 46014/C with a purity of 18 % was performed in a pre-guideline test in six rabbits. Animals have been instilled with 0.1 ml of the test substance in one eye while the other one left untreated and served as internal control. 1 min after test substance instillation eyes have been rinsed with saline to flush remaining test material out of the eyes. While slight scores of conjunctival redness occurred in treated animals at the first reading after one hour all scores had returned to zero after 6 hours. Therefore for the 24, 48 and 72 hour readings all scored have been zero. Based on these test results the substance was judged not-irritating to the eye. In the fourth study FAT 46014/B with a purity of 45 % was performed in a pre-guideline test in six rabbits. Animals have been instilled with 0.1 ml of the test substance in one eye while the other one left untreated and served as internal control. 30 seconds after test substance instillation eyes have been rinsed with saline to flush remaining test material out of the eyes. At the first reading after one day all scores reported have been zero as well as all scores at the 48 and 72 hour readings. No further signs of irritation or other effects on the eye have been reported. Based on these test results the substance was judged not-irritating to the eye. Last but not least a study has been performed on FAT 46014/A with a purity of 45 %. Animals have been instilled with 0.1 mg of the test substance in one eye while the other one left untreated and served as internal control. 30 seconds after test substance instillation eyes have been rinsed with saline to flush remaining test material out of the eyes. At the first reading after one day all scores reported have been zero as well as all scores at the 48 and 72 hour readings. No further signs of irritation or other effects on the eye have been reported. Based on these test results the substance was judged not-irritating to the eye. In summary it can be noted that in general all tests may be used for assessment of the irritation potential to the eye of rabbits (weight of evidence approach). In all cases tests have been conducted either according to OECD guideline 405 or according to the procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO) representing a test standard being used as a guidance to develop OECD Guideline 405 in the late 1980ies. Based on above mentioned results it remains unclear why clear irritating effects have been observed with FAT 46014/F having only a test substance purity of about 36 % while other test sample preparations having much higher test substance concentrations led to no irritation at all (FAT 46014/A and FAT 46014/B). And also results with a comparable purity demonstrated no irritating effects at all (FAT 46014/E). So the only difference is that in all other studies the treated eyes have been flushed with either lukewarm water or physiological saline to remove remaining test material after 30 sec or 1 minute to prevent mechanical damage to the eye which is known to also cause irritating effects. Another option could be that maybe other ingredients present in the coupage of the test material caused those effects, but this remains elusive. In summary, the registrant proposes to judge the test material as non-irritant to the skin and irritant to the eye. Judgement is based on the key study selected for skin irritation and based on a worst case approach taking all available data for eye irritation into account.
Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study
Justification for selection of eye irritation endpoint:
Weight of evidence approach
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study completion date: 29 February, 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- Code No. : FAT 46014/F
Batch No. : EN 94071.32
Stability: guaranteed by the sponsor until November 1988
Description: solid
Contents of active ingredient: 35.7 %
Test Article Received: December 6, 1983 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Füllinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 1930-2270 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: at least 6 cm²
SCORING SYSTEM:
<0.5: non-irritant
0.6 - 3.0: slightly irritant
3.1 - 5.0: irritant
5.1 - 8.0: severely irritant - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 8
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Animal #3 had slight erythema at 1 hour observation only
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24h
- Remarks on result:
- other: Animal #3 has slight edema at 1 hour observation only.
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 46014/F was found to be non-irritant and not corrosive when applied to the rabbit skin.
- Executive summary:
The skin irritation potential of FAT 46014/F with purity of 35.7 % was evaluated in a study conducted according to OECD Guideline 404. 3 Female rabbits were used for this purpose. This test was conducted in GLP compliance. The test was carried out on shaved intact skin. Animal #3 had slight erythema and edema at 1 hour observation only, which was resolved within 24 hours. The means scores for 24/48/72 hour observations were 0 for both erythema and edema reactions. Hence, FAT 46014/F can be classified as non-irritant and not corrosive to rabbit skin.
Referenceopen allclose all
Scoring of erythema and eschar formation.
Animal No./Sex | 1h | 24h | 48h | 72h | days | days |
34/F | 0 | 0 | 0 | 0 | ||
35/F | 0 | 0 | 0 | 0 | ||
36/F | 1 | 0 | 0 | 0 | ||
Total | 1 | 0 | 0 | 0 | = 1 | (A) |
Scoring of Oedema formation
Animal No./Sex | 1h | 24h | 48h | 72h | days | days |
34/F | 0 | 0 | 0 | 0 | ||
35/F | 0 | 0 | 0 | 0 | ||
36/F | 1 | 0 | 0 | 0 | ||
Total | 1 | 0 | 0 | 0 | = 1 | (B) |
Index of Skin irritation: A1 + B1 = 2 :12 = 0.17
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Study completion date: 12 March, 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Code No. : FAT 46014/F
Batch No. : EN 94071.32
Stability: guaranteed by the sponsor until November 1988
Description: solid
Contents of active ingredient: 35.7 %
Test Article Received: December 6, 1983 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 1890-2090 g
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15 air changes/h.
- Photoperiod (hrs dark / hrs light): 12 hours light/day - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye remained untreated and served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- one second
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period by means of a slit-lamp. The ocular irritation scores were evaluated according to the scoring system presented in the following table. The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals and taking into account the reversibility of the effect. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritant / corrosive response data:
- None
- Other effects:
- The animals showed a normal body weight development.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- FAT 46014/F is an irritant when applied to the rabbit eye mucosa.
- Executive summary:
The eye irritation potential of FAT 46014/ F evaluated in a study conducted according to OECD Guideline 405. 0.1 g of FAT 46014/F was placed into the conjunctival sac of the right eye of each of 3 male rabbits, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 46014/F. The mean scores for corneal opacity, iris, conjunctival redness and chemosis were 1.22, 1.11, 2.56 and 2, respectively. The substance was found to be severely irritant and not corrosive when applied to the rabbit eye mucosa, however the animals had recovered at the end of the observation period of 11 days. Based on the scores obtained and full reversibility, the substance is considered to be eye irritant (category 2).
Referenceopen allclose all
Evaluation of eye reactions
Cornea
Animal No/Sex | 31/M | 32/M | 33/M |
After 1 hr | 2 | 2 | 2 |
After 24 hr | 2 | 1 | 2 |
After 48 hr | 1 | 1 | 1 |
After 72 hr | 1 | 1 | 1 |
After 7 days | 0 | 0 | 0 |
After 11 days | 0 | 0 | 0 |
Iris
Animal No/Sex | 31/M | 32/M | 33/M |
After 1 hr | 1 | 1 | 1 |
After 24 hr | 1 | 2 | 1 |
After 48 hr | 1 | 1 | 1 |
After 72 hr | 1 | 1 | 1 |
After 7 days | 0 | 0 | 0 |
After 11 days | 0 | 0 | 0 |
Conjuctiva -( redness in bulbar and palpebral membranes)
Animal No/Sex | 31/M | 32/M | 33/M |
After 1 hr | 2 | 2 | 2 |
After 24 hr | 2 | 3 | 3 |
After 48 hr | 2 | 3 | 3 |
After 72 hr | 1 | 3 | 3 |
After 7 days | 0 | 1 | 1 |
After 11 days | 0 | 0 | 0 |
Conjuctiva -( chemosis in lids and nictating membranes)
Animal No/Sex | 31/M | 32/M | 33/M |
After 1 hr | 4 | 2 | 3 |
After 24 hr | 2 | 3 | 2 |
After 48 hr | 2 | 3 | 2 |
After 72 hr | 1 | 2 | 1 |
After 7 days | 0 | 0 | 0 |
After 11 days | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In summary, the registrant proposes to judge the test material as non-irritant to the skin and irritant to the eye. Judgement is based on the key study selected for skin irritation and based on a worst case approach taking all data available for eye irritation into account.
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.