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EC number: 280-068-8 | CAS number: 82933-90-2
- 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
Taking data from both skin and eye irritation/corrosion studies into account, it can be concluded that the test substance FAT 20043 is non-irritating to skin and eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: The test was carried out according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965).
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-13 weeks
- Weight at study initiation: average body weights of 2.73 Kgs. (males) and 2.38 Kgs. (females)
- Housing:The rabbits were caged singly in an experimental room.
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: Six rabbits were acclimatized in the test area for one week prior to the start of the trial.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light):Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. - Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 g of the test compound was mixed with 12 ml. of water to make a solution of 15ml. 0.75ml. of which was applied to each test- site on a 2.5 cm. square gauze pad. - Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 h and 72 h
- Number of animals:
- Six rabbits ( 3 male and 3 female)
- Details on study design:
- TEST SITE
Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand sits remained intact.
These were covered with aluminum foil secured with "Sleek"* adhesive tape. The test sites were then enclosed by a 6" wide "Cobon” self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.
SCORING SYSTEM:
Primary irritation score Rating
0 Non irritating
0.1 - 0.5 Minimally irritating
0.6 - 1.5 Slightly irritating
1.6 - 3.0 Mildly irritating
3.1 - 5.0 Moderately irritating
5.1 - 6.5 Severely irritating
6.6 - 8.0 Extremely irritating - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animal (intact skin)
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animal (intact skin)
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animal (Abraded skin)
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animal (Abraded skin)
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animal (intact skin)
- Time point:
- 24 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animal (intact skin)
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animal (Abraded skin)
- Time point:
- 24 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animal (Abraded skin)
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20043/B is a slight to moderate primary skin irritant in the albino rabbit.
- Executive summary:
A skin irritation potential was determined of FAT 20043/B according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965).
Slight erythema and very slight to moderate edema was seen on 2/6 and 6/6 rabbits respectively, 24 hours after application of the compound. All sites were normal by 72 hours. There was no marked difference in the reactions between abraded and intact sites. The primary irritation score was 1.0. FAT 20043/B is a slight primary skin irritant in the albino rabbit. Based on the finding in the skin irritation studies, the test substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Reference
Erythema Formation:
No./Sex | Intact | Abraded | Total | ||
24 hrs | 72 hrs | 24 hrs | 72 hrs | ||
11 | 0 | 0 | 0 | 0 | |
13 | 0 | 0 | 0 | 0 | |
15 | 0 | 0 | 0 | 0 | |
12 | 0 | 0 | 1 | 0 | |
14 | 1 | 0 | 1 | 0 | |
16 | 0 | 0 | 0 | 0 | |
Mean | 0.17 | 0 | 0.33 | 0 | 0.5 |
Oedema Formation
No./Sex | Intact | Abraded | Total | ||
24 hrs | 72 hrs | 24 hrs | 72 hrs | ||
11 | 2 | 0 | 3 | 0 | |
13 | 0 | 0 | 1 | 0 | |
15 | 2 | 0 | 2 | 0 | |
12 | 1 | 0 | 1 | 0 | |
14 | 3 | 0 | 2 | 0 | |
16 | 2 | 0 | 1 | 0 | |
Mean | 1.67 | 0 | 1.67 | 0 | 3.33 |
Total Erythema + Oedema Score = 3.83
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: The test was carried out in accordance with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: average body weights of 2.73 kgs. (males) and 2.38 kgs. (females)
- Housing:The rabbits were caged singly in an experimental room.
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum.
- Water:Sterile filtered water was available at all times.
- Acclimation period: Six rabbits were acclimatised in the test area for one week prior to the start of the trial
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50-70
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg. - Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- Six rabbits (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):After 30 seconds the compound was, as far as possible, flushed out of the eyes' of three of the rabbits with warm water for 1 minute.
SCORING SYSTEM:The ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.
Score Assessment
0 : Non irritant
0 - 10: Minimally irritant
11 - 25: Slightly irritant
26 - 56: Moderately irritant
57 - 84: Markedly irritant
>84: Extremely irritant - Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 0.16
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- A slight to moderate conjunctival reaction was seen in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours and thereafter continued to do so until all eyes were normal by 48 hours (1/3 washed) 72 hours (2/3 unwashed 2/3 washed) and 6 days (1/3 unwashed). Staining of the conjunctivae and cornea by the compound was seen in the unwashed eyes for up to 40 hours.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20043/B is a minimal eye irritant in the albino rabbit.
- Executive summary:
A study was performed to determine the eye irriattion potential of FAT 20043/B in rabbits according to with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification. 100 mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes' of three of the rabbits with warm water for 1 minute. There was no effects observed for cornea and iris at 24 and 48 h observation period, however redness and discharge were seen but get reversed after 72 hrs. In conclusion, FAT 20043/B is a minimal eye irritant in the albino rabbit and based on the finding in the eye irritation studies, the test substance does not need to be classified according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Reference
Rabbit eye irritation scores-reference procedure:
1 hour | 6 hours | 1 Day | 2 Days | 3 Days | 6 Days | |||||||||||||||||||||||||||||||||||||
Rabbit No | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | 11 | 13 | 15 | 12 | 14 | 16 | ||||||
Conjuctivae | ||||||||||||||||||||||||||||||||||||||||||
A | Redness | 2 | 2 | 2 | 2 | 1 | 1 | - | - | - | - | - | - | 1 | 2 | 1 | 2 | 1 | 1 | 1 | 1 | - | 1 | 1 | 1 | - | 1 | - | - | - | - | - | - | - | - | - | - | |||||
B | Chemosis | 2 | 2 | 1 | 2 | 1 | 2 | - | - | - | - | - | - | 1 | 1 | - | 1 | - | - | 1 | 1 | - | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
C | Discharge | 2 | 1 | - | 3 | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | - | |||||
c=(A+B+C) X2 | (max. 20) | 12 | 10 | 6 | 14 | 4 | 6 | - | - | - | - | - | - | 4 | 6 | 2 | 6 | 2 | 2 | 4 | 4 | - | 4 | 2 | 2 | - | 2 | - | - | - | - | - | - | - | - | - | - | |||||
Total | (Max.110) | 12 | 10 | 6 | 14 | 4 | 6 | - | - | - | - | - | - | 4 | 6 | 2 | 6 | 2 | 2 | 4 | 4 | - | 4 | 2 | 2 | - | 2 | - | - | - | - | - | - | - | - | - | - |
Eyes washed in Nos. 14, 15 & 16 hours
No effects were observed for cornea and iris.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
A skin irritation potential was determined of FAT 20043/B according to the method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous. Substances Labelling Act Sect. 191.11 (February 1965). Slight erythema and very slight to moderate edema was seen 24 hours after application of the compound on 2/6 and 6/6 rabbits, respectively. All sites were normal by 72 hours. There was no marked difference in the reactions between abraded and intact sites. The primary irritation score was 1.0. It can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general, abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment. Hence, FAT 20043/B can be considered as non-irritating to rabbit’s skin. In another supporting study, the test was to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound on the skin of the rabbits. The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0. Therefore FAT 20043/A is to be considered as non-irritant to the skin of rabbits. Considering the results from key study and supporting study it can be concluded that FAT 20043 is non-irritating to rabbit’s skin.
Eye Irritation:
A study was performed to determine the eye irritation potential of FAT 20043/B in rabbits according to with the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification. In conclusion, FAT 20043/B is a minimal eye irritant in the albino rabbit. A supporting study was performed to determine the eye irritation potential of FAT 20043/A in rabbits according to the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO). The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and o for the conjunctivae. Therefore, FAT 20043/A is to be considered non-irritant to the eye of rabbits.
Justification for selection of skin irritation / corrosion endpoint:
Non-GLP guideline study
Justification for selection of eye irritation endpoint:
Non-GLP guideline study
Justification for classification or non-classification
Based on the finding in the skin and eye irritation studies, the test substance does not need to be classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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