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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
- 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
FAT 40069/A is to be considered as a non- irritant to the skin and eye of rabbits.
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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959) of the US Association of Food and Drug Official (AFDO).
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: In order to prevent injuries by bites the rabbits were kept separately in V2A wire mesh cages
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- on the whole back and flanks two days before treatment with an electric clipper
- Vehicle:
- other: PEG 400 (Polyethylene glycol)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- FAT 40069/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- Rabbits were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The gauze patches were removed 2 4 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme.
SCORING SYSTEM:
Erythema and Eschar Formation
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Total possible erythema score: 4
Edema Formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising: 2
- Moderate edema (raised approximately 1 mm): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score: 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 males and 3 females
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks:
- Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40069/A is considered as non-irritant to the rabbit skin.
- Executive summary:
A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40069/A, on the skin of the rabbits according to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959) of the US Association of Food and Drug Official (AFDO). Six rabbits (3 males and 3 females), Russian breed, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. FAT 40069/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. In conclusion, The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.5. FAT 40069/A is to be considered as a non-irritant to the skin of rabbits.
Reference
Evaluation of the skin reactions:
Animal No. / Sex | Skin Reaction | 24 hours after application | 72 hours after application | ||
Intact skin | sacrificed skin | Intact skin | sacrificed skin | ||
1/M | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 1 | 0 | 0 | |
2/M | Erythema | 0 | 0 | 0 | 0 |
Oedema | 2 | 2 | 0 | 1 | |
3/M | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 1 | 0 | 0 | |
4/F | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
5/F | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 2 | 0 | 0 | |
6/F | Erythema | 0 | 0 | 0 | 0 |
Oedema | 1 | 1 | 0 | 0 |
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:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: The procedure adopted was 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).
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: V2A wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g of the test substance
- Duration of treatment / exposure:
- One application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.
SCORING SYSTEM:
Cornea
A. Opacity-degree of density (area most dense taken for reading)
- No opacity: 0
- Scattered or diffuse area, details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
- Opaque, iris invisible: 4
B. Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter, but less than half: 2
- Greater than half, but less than three quarters: 3
- Greater than three quarters, up to whole area: 4
Total maximum = 80 (A x B x 5)
Iris
A. Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive): 1
- No reaction to light, hemorrhage, gross destruction (any or all of these): 2
A x 5
Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Vessels normal: 0
- Vessels definitely injected above normal: 1
- More diffuse, deeper crimson red, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
B. Chemosis
- No swelling: 0
- Any swelling above normal (includes nictitating membrane): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half closed: 3
- Swelling with lids about half closed to completely closed: 4
C. Discharge
- No discharge: 0
- Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
- Discharge with moistening of the lids and hairs just adjacent to lids: 2
- Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
(A + B + C) x 2 Total maximum = 20
The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 females (eyes rinsed)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- eyes rinsed
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- eyes rinsed
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- eyes rinsed
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- eyes rinsed
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- eyes rinsed
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- eyes rinsed
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 female eyes rinsed and 3 female eyes not rinsed
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The results of the eye irritation test are summarized in tables 1 and 2. The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae. The irritation index was found to be 10.8 for the cornea, 0 for the iris and 6.9 for the conjunctivae.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40069/A is to be considered as a non-irritant to the eye of rabbits.
- Executive summary:
A study was performed to determine the eye irritation potential of FAT 40069/A on rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed and only rabbits showing normal ophthalmic findings were included in the test. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 10.8 for the cornea, 0 for the iris and 6 .9 for the conjunctivae. The effects were observed to be completely reversible by the end of Day 7. FAT 40069/A is to be considered as a non-irritant to the eye of rabbits.
Reference
Eyes rinsed:
Days after application | Rabbit 1 Female | Rabbit 2 Female | Rabbit 3 Female | ||||||
Cornea | Iris | Conjuct. | Cornea | Iris | Conjuct. | Cornea | Iris | Conjuct. | |
1 | 0 | 0 | 10 | 0 | 0 | 10 | 0 | 0 | 12 |
2 | 0 | 0 | 6 | 0 | 0 | 10 | 0 | 0 | 10 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Eyes not rinsed:
Days after application | Rabbit 4 Male | Rabbit 5 Male | Rabbit 6 Male | ||||||
Cornea | Iris | Conjuct. | Cornea | Iris | Conjuct. | Cornea | Iris | Conjuct. | |
1 | 20 | 0 | 18 | 10 | 0 | 16 | 30 | 0 | 18 |
2 | 30 | 0 | 12 | 5 | 0 | 12 | 45 | 0 | 12 |
3 | 40 | 0 | 12 | 0 | 0 | 10 | 45 | 0 | 10 |
4 | 30 | 0 | 8 | 0 | 0 | 6 | 40 | 0 | 6 |
7 | 20 | 0 | 8 | 0 | 0 | 0 | 10 | 0 | 0 |
Data represent values of calculated primary eye irritation index. Eyes not rinsed should not be taken into account for the overall hazard assessment.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was carried out to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40069/A, on the skin of the rabbits according to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959) of the US Association of Food and Drug Official (AFDO). The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.5. The effects were observed to be completely reversable by the end of Day 7. FAT 40069/A is to be considered as a non-irritant to the skin of rabbits.
A study was performed to determine the eye irritation potential of FAT 40069/A in rabbits according to 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 10.8 for the cornea, 0 for the iris and 6 .9 for the conjunctivae.
The effects were observed to be completely reversible by the end of Day 7. FAT 40069/A is to be considered as a non-irritant to the eye of rabbits
Justification for selection of skin irritation / corrosion
endpoint:
Basic data given, acceptable for assessment
Justification for selection of eye irritation endpoint:
Basic data given, acceptable for assessment
Justification for classification or non-classification
Based on the above stated assessment, FAT 40069/A is to be considered as a non-irritant to the skin and eyes of rabbits according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council.
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.